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A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression

Primary Purpose

Depressive Disorder, Major

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 1358894
Placebo
Quetiapine
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

--Established diagnosis of Major Depressive Disorder (MDD), single episode or recurrent, as confirmed at the time of screening by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th version (DSM-5) (SCID-5), with a duration of current depressive episode ≥ 8 weeks and ≤ 24 months at the time of screening visit

  • Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 24 at screening, as confirmed by a trained site based rater AND interactive, computer administered MADRS. The difference in the rater and computer administered MADRS must not exceed more than 7 points (for details refer to section 6.2). In addition, trial participants must have a score of ≥ 3 on the Reported Sadness Item on both MADRS scales (computer administered and rater-administered MADRS)
  • A documented ongoing monotherapy treatment of ≥ 4 weeks at the screening visit, with bupropion or a protocol specified Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) (refer to the ISF) at adequate dose (at least minimum effective dose as per prescribing information and as confirmed per detectable drug levels in the screening blood or urine sampling)
  • Male and female participants, 18 to 65 years of age, both inclusively at the time of consent
  • Women who are of child-bearing potential (WOCBP)1 must be able and willing, as confirmed by the investigator, to use two methods of contraception which include one highly effective method of birth control per ICH M3 (R2) that result in a low failure rate of less than 1%, plus one additional barrier
  • Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
  • Able to communicate well, and to understand and comply with trial requirements

Exclusion Criteria:

  • Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder or MDD with psychotic features as assessed by the Structured Clinical Interview for DSM-5 Clinical Trials (SCID-5) at the time of screening
  • Diagnosis of any other mental disorder (in addition to those as described in Exclusion Criterion #1) that was the primary focus of treatment within 6 months prior to screening or at baseline (as per clinical discretion of the investigator)
  • Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder as per DSM-5 criteria, at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator
  • Diagnosis of a substance related disorder within 3 months prior to screening visit (with exception of caffeine and tobacco)
  • History of seizure disorders, stroke, brain tumor or any other major neurological illness that can impact participation in the trial
  • History of more than 2 unsuccessful monotherapy treatments (at adequate dosage and duration, per local prescribing information of the product) with an approved antidepressant medication for the current ongoing major depressive episode. These include ongoing monotherapy treatment with bupropion or a protocol specified SSRI or SNRI as described in Inclusion Criterion #3
  • Any suicidal behavior in the past 12 months prior to screening (per investigator judgement including an actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
  • Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months prior to screening or at screening or baseline visit (i.e. active suicidal thought with method and intent but without specific plan, or active suicidal thought with method, intent and plan)

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • Encino Hospital Medical CenterRecruiting
  • Collaborative Neuroscience Network, LLC (CNS)
  • Alliance ResearchRecruiting
  • California Neuroscience ResearchRecruiting
  • Schuster Medical Research InstituteRecruiting
  • Viking Clinical Research, Ltd.Recruiting
  • Collaborative Neuroscience Research, LLCRecruiting
  • Mountain Mind. LLCRecruiting
  • CT Clinical ResearchRecruiting
  • Institute of Living
  • Gulf Coast Clinical Research CenterRecruiting
  • Sarkis Clinical TrialsRecruiting
  • Clinical Neuroscience Solutions, IncRecruiting
  • Optimus U CorporationRecruiting
  • Advanced Discovery Research LLCRecruiting
  • Atlanta Center
  • Chicago Research Center, IncorporatedRecruiting
  • University of Kansas School of Medicine-WichitaRecruiting
  • Precise Research CentersRecruiting
  • Psychiatric Care and Research CenterRecruiting
  • Center For Emotional FitnessRecruiting
  • Hassman Research InstituteRecruiting
  • Synexus Clinical Research US, Inc.
  • University of CincinnatiRecruiting
  • The Ohio State University Wexner Medical CenterRecruiting
  • Lehigh Center for Clinical Research
  • Global Medical Institutes, LLC, Scranton Medical InstituteRecruiting
  • Core Clinical ResearchRecruiting
  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)Recruiting
  • CEN (Centro Especializado Neurociencias)Recruiting
  • Instituto DAMIC - Fundacion RusculledaRecruiting
  • CENPIA-Centro de Estudios Neuropsiquiátricos y Psicológicos Integral AmbulatorioRecruiting
  • Clinica Privada de Salud Mental Santa Teresa de AvilaRecruiting
  • Instituto de Neurociencias San AgustínRecruiting
  • Instituto Médico de la Fundación Estudios ClínicosRecruiting
  • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)Recruiting
  • Griffith Health
  • Peninsula Therapeutic and Research GroupRecruiting
  • Albert Road ClinicRecruiting
  • Monash Alfred Psychiatry Research CentreRecruiting
  • Mental Health Center "Prof. Dr. Ivan Temkov - Burgas" EOODRecruiting
  • SPH "Sveti Ivan Rilsкi"Recruiting
  • "Filipopolis" - Ambulatory for Group Practice for Specialized Care in PsychiatryRecruiting
  • Medical Center Intermedica Ltd.Recruiting
  • University of CalgaryRecruiting
  • OCT Research ULCRecruiting
  • UBC HospitalRecruiting
  • Braxia Scientific Corp. (CRTCE Mississauga)Recruiting
  • Centre for Addiction and Mental Health (CAMH)Recruiting
  • Neuropsychiatry, s.r.o.
  • Clinical Research Foundation s.r.oRecruiting
  • MPMeditrine s.r.o.Recruiting
  • A-SHINE s.r.o
  • Clintrial s.r.o.Recruiting
  • AD71 s.r.o.Recruiting
  • INEP medical s.r.o.Recruiting
  • HOP Dijon-BourgogneRecruiting
  • CAB Médical PsychéRecruiting
  • CAB Ambroise Paré
  • HOP la ColombièreRecruiting
  • HOP Saint-JacquesRecruiting
  • HOP PasteurRecruiting
  • HOP CarémeauRecruiting
  • CTR Psychiatrique UniversitaireRecruiting
  • HOP PurpanRecruiting
  • Zentrum für klinische Forschung Dr. med. I. SchöllRecruiting
  • Universitätsklinikum FrankfurtRecruiting
  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz
  • Zentralinstitut für seelische GesundheitRecruiting
  • Praxis für Psychiatrie und PsychotherapieRecruiting
  • Studienzentrum Nord-WestRecruiting
  • Obudai Egeszsegugyi CentrumRecruiting
  • Semmelweis UniversityRecruiting
  • Bugat Pal Hospital, GyongyosRecruiting
  • National Center for Global Health and Medicine Kohnodai HospitalRecruiting
  • Kaku Mental ClinicRecruiting
  • Fukuoka University HospitalRecruiting
  • Kuramitsu HospitalRecruiting
  • Hokudai-dori Mental Health ClinicRecruiting
  • Arai Clinic
  • Tatsuta ClinicRecruiting
  • Kishiro Mental ClinicRecruiting
  • Yutaka ClinicRecruiting
  • Yuge Neuropsychiatric HospitalRecruiting
  • Arata Clinic
  • Nara Medical University HospitalRecruiting
  • Rainbow and Sea HospitalRecruiting
  • Inuo HospitalRecruiting
  • National Center of Neurology and Psychiatry
  • Tamachi mita cocoromi ClinicRecruiting
  • Sancha Mental ClinicRecruiting
  • Maynds Tower Mental ClinicRecruiting
  • Ichigaya Himorogi ClinicRecruiting
  • Ohwa Mental ClinicRecruiting
  • Synexus Polska SCM Sp. z o.o. Gdansku, GdanskRecruiting
  • Synexus Lodz Medical CenterRecruiting
  • Specialist Psychiatric Healthcare Centre in LodzRecruiting
  • Clinical Best SolutionsRecruiting
  • Centrum Medyczne "Luxmed" Sp. z o.o.Recruiting
  • Synexus Poland, Branch in PoznanRecruiting
  • Federal State Budget Institution "Mental Health Research Center"
  • SBI of HC "Z. P. Solovyov Scientific&pract psychoneurolog.Cent"
  • SHI "Reg.Clin.Psychiatric Hosp.of Saint Sophia"
  • FSBEI of HE Smolensk State Medical University
  • SBHI "Psychiatric Hospital #1 P.P.Kashchenko"
  • FSBI Bekhterev Net.Med.Res.Cen.of Psych&Neuro
  • LLC "MK-Med"
  • MUDr. Beata Dupejová
  • J & J SMART, s.r.o., psychiatric clinicRecruiting
  • Old Town Bratislava University Hosp,Recruiting
  • MENTUM s.r.o.Recruiting
  • EPAMED s.r.o.Recruiting
  • Psychiatricka klinika I.UN L. PasteuraRecruiting
  • CENTRUM ZDRAVIA R.B.K, s.r.o., psychiatric clinicRecruiting
  • Pro mente sana s.r.o., Psychiatric clinicRecruiting
  • Crystal Comfort s.r.o
  • Hospital Universitario Fundación AlcorcónRecruiting
  • Hospital Clínic de BarcelonaRecruiting
  • Hospital Jerez de la FronteraRecruiting
  • Hospital Ramón y CajalRecruiting
  • Hospital Puerta de HierroRecruiting
  • Centro de Salud de San JuanRecruiting
  • Hospital Universitario Marqués de ValdecillaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Treatment group 1

Placebo group

Treatment group 2

Arm Description

BI 1358894

Placebo

Quetiapine

Outcomes

Primary Outcome Measures

Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
The MADRS consists of 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thought, suicidal thoughts. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). The possible total score could range from 0 to 60 (from normal with absence of symptoms to severe depression).

Secondary Outcome Measures

Response defined as ≥ 50% MADRS reduction from baseline
Change from baseline in State-Trait Anxiety Inventory (STAI) State and Trait version scores
The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel "right now, at this moment." The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how people generally feel. Each STAI item is given a weighted score of 1 to 4. A rating of 4 indicates the presence of a high level of anxiety for ten S-Anxiety items and eleven T-Anxiety items (e.g., "I feel frightened," "I feel upset"). A high rating indicates the absence of anxiety for the remaining ten S-Anxiety items and nine T-Anxiety items (e.g., "I feel calm," "I feel relaxed").Scores for both the S-Anxiety and the T-Anxiety scales can vary from a minimum of 20 to a maximum of 80. Higher scores indicate greater anxiety.
Change from baseline in Clinical Global Impression Severity Scale (CGI-S) score
The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience with the depression population, a participant is assessed on severity of illness at the time of rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. Higher scores indicate worsening.
Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score
The different categories and associated 16 items are: Negative Emotions/Mood: sadness, hopeless/helpless, irritability, anhedonia; Anxiety: feeling overwhelmed, worry; Low Energy: tiredness; Cognition: intrusive thoughts, poor concentration; Sleep Disturbances: general sleep adequacy; Self Harm/Suicide: life not worth living; Low Motivation: lack of drive, no interest in activities; Sense of Self: self-blame; Eating Behavior: poor appetite, overeating. The SMDDS uses a recall of "over the past 7 days" and participants respond to each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"). The total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology.

Full Information

First Posted
August 18, 2020
Last Updated
October 16, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04521478
Brief Title
A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression
Official Title
A Phase II, 6-week, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel Group Trial With a Quetiapine Arm to Evaluate the Efficacy, Tolerability and Safety of Oral BI 1358894 in Patients With Major Depressive Disorder With Inadequate Response to Antidepressants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
January 4, 2024 (Anticipated)
Study Completion Date
February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study is open to adults with depression (major depressive disorder) for whom standard treatment with antidepressants alone does not work sufficiently. The purpose of the trial is to find out whether a medicine called BI 1358894 helps to improve symptoms of depression. Four different doses of BI 1358894 are tested in the study. Participants continue their standard antidepressant therapy throughout the study. Participants are put into 6 groups by chance. Participants in 4 of the 6 groups take different doses of BI 1358894, and placebo. Participants in the fifth group take quetiapine, a medicine already used to treat depression, and placebo. Participants in the sixth group take placebo only. Participants take BI 1358894, quetiapine, or placebo as tablets. Placebo tablets look like BI 1358894 or quetiapine tablets but do not contain any medicine. Each participant takes tablets twice a day. Participants are in the study for about 3 months. During this time, they visit the study site about 8 times and get about 2 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups, the quetiapine group, and the placebo group are then compared. The doctors also regularly check the general health of the participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
431 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment group 1
Arm Type
Experimental
Arm Description
BI 1358894
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Treatment group 2
Arm Type
Experimental
Arm Description
Quetiapine
Intervention Type
Drug
Intervention Name(s)
BI 1358894
Intervention Description
BI 1358894
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Description
quetiapine
Primary Outcome Measure Information:
Title
Change from baseline in Montgomery-Åsberg Depression Rating Scale (MADRS) total score
Description
The MADRS consists of 10 items: apparent sadness, reported sadness, inner tension, reduced sleep, reduced appetite, concentration difficulties, lassitude, inability to feel, pessimistic thought, suicidal thoughts. MADRS items are rated on a 0-6 continuum (0=no abnormality, 6=severe). The possible total score could range from 0 to 60 (from normal with absence of symptoms to severe depression).
Time Frame
At week 6
Secondary Outcome Measure Information:
Title
Response defined as ≥ 50% MADRS reduction from baseline
Time Frame
At week 6
Title
Change from baseline in State-Trait Anxiety Inventory (STAI) State and Trait version scores
Description
The S-Anxiety scale (STAI Form Y-1) consists of twenty statements that evaluate how respondents feel "right now, at this moment." The T-Anxiety scale (STAI Form Y-2) consists of twenty statements that assess how people generally feel. Each STAI item is given a weighted score of 1 to 4. A rating of 4 indicates the presence of a high level of anxiety for ten S-Anxiety items and eleven T-Anxiety items (e.g., "I feel frightened," "I feel upset"). A high rating indicates the absence of anxiety for the remaining ten S-Anxiety items and nine T-Anxiety items (e.g., "I feel calm," "I feel relaxed").Scores for both the S-Anxiety and the T-Anxiety scales can vary from a minimum of 20 to a maximum of 80. Higher scores indicate greater anxiety.
Time Frame
At week 6
Title
Change from baseline in Clinical Global Impression Severity Scale (CGI-S) score
Description
The CGI-S evaluates the severity of psychopathology on a scale of 1 to 7. Considering total clinical experience with the depression population, a participant is assessed on severity of illness at the time of rating according to: 1=normal (not at all ill); 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill participants. Higher scores indicate worsening.
Time Frame
At week 6
Title
Change from baseline in Symptoms of Major Depressive Disorder Scale (SMDDS) total score
Description
The different categories and associated 16 items are: Negative Emotions/Mood: sadness, hopeless/helpless, irritability, anhedonia; Anxiety: feeling overwhelmed, worry; Low Energy: tiredness; Cognition: intrusive thoughts, poor concentration; Sleep Disturbances: general sleep adequacy; Self Harm/Suicide: life not worth living; Low Motivation: lack of drive, no interest in activities; Sense of Self: self-blame; Eating Behavior: poor appetite, overeating. The SMDDS uses a recall of "over the past 7 days" and participants respond to each question using a rating scale between 0 ("Not at all" or "Never") to 4 ("Extremely" or "Always"). The total score ranges from 0 to 60 with a higher score indicating more severe depressive symptomatology.
Time Frame
At week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: --Established diagnosis of Major Depressive Disorder (MDD), single episode or recurrent, as confirmed at the time of screening by the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, 5th version (DSM-5) (SCID-5), with a duration of current depressive episode ≥ 8 weeks and ≤ 24 months at the time of screening visit Montgomery-Åsberg Depression Rating Scale (MADRS) total score ≥ 24 at screening, as confirmed by a trained site based rater AND interactive, computer administered MADRS. The difference in the rater and computer administered MADRS must not exceed more than 7 points (for details refer to section 6.2). In addition, trial participants must have a score of ≥ 3 on the Reported Sadness Item on both MADRS scales (computer administered and rater-administered MADRS) A documented ongoing monotherapy treatment of ≥ 4 weeks at the screening visit, with bupropion or a protocol specified Selective Serotonin Reuptake Inhibitor (SSRI) or Serotonin Norepinephrine Reuptake Inhibitor (SNRI) (refer to the ISF) at adequate dose (at least minimum effective dose as per prescribing information and as confirmed per detectable drug levels in the screening blood or urine sampling) Male and female participants, 18 to 65 years of age, both inclusively at the time of consent Women who are of child-bearing potential (WOCBP)1 must be able and willing, as confirmed by the investigator, to use two methods of contraception which include one highly effective method of birth control per ICH M3 (R2) that result in a low failure rate of less than 1%, plus one additional barrier Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial Able to communicate well, and to understand and comply with trial requirements Exclusion Criteria: Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar disorder, delusional disorder or MDD with psychotic features as assessed by the Structured Clinical Interview for DSM-5 Clinical Trials (SCID-5) at the time of screening Diagnosis of any other mental disorder (in addition to those as described in Exclusion Criterion #1) that was the primary focus of treatment within 6 months prior to screening or at baseline (as per clinical discretion of the investigator) Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder as per DSM-5 criteria, at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and likely to impact trial participation, as per the judgement of investigator Diagnosis of a substance related disorder within 3 months prior to screening visit (with exception of caffeine and tobacco) History of seizure disorders, stroke, brain tumor or any other major neurological illness that can impact participation in the trial History of more than 2 unsuccessful monotherapy treatments (at adequate dosage and duration, per local prescribing information of the product) with an approved antidepressant medication for the current ongoing major depressive episode. These include ongoing monotherapy treatment with bupropion or a protocol specified SSRI or SNRI as described in Inclusion Criterion #3 Any suicidal behavior in the past 12 months prior to screening (per investigator judgement including an actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS) in the past 3 months prior to screening or at screening or baseline visit (i.e. active suicidal thought with method and intent but without specific plan, or active suicidal thought with method, intent and plan)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Boehringer Ingelheim
Phone
1-800-243-0127
Email
clintriage.rdg@boehringer-ingelheim.com
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Encino Hospital Medical Center
City
Encino
State/Province
California
ZIP/Postal Code
91436
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Collaborative Neuroscience Network, LLC (CNS)
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Individual Site Status
Terminated
Facility Name
Alliance Research
City
Long Beach
State/Province
California
ZIP/Postal Code
90807
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
California Neuroscience Research
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Schuster Medical Research Institute
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Viking Clinical Research, Ltd.
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Collaborative Neuroscience Research, LLC
City
Torrance
State/Province
California
ZIP/Postal Code
90504
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Mountain Mind. LLC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
CT Clinical Research
City
Cromwell
State/Province
Connecticut
ZIP/Postal Code
06416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Institute of Living
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Individual Site Status
Terminated
Facility Name
Gulf Coast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Clinical Neuroscience Solutions, Inc
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Optimus U Corporation
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Advanced Discovery Research LLC
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Atlanta Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331
Country
United States
Individual Site Status
Completed
Facility Name
Chicago Research Center, Incorporated
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60634
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
University of Kansas School of Medicine-Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Psychiatric Care and Research Center
City
O'Fallon
State/Province
Missouri
ZIP/Postal Code
63368
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Center For Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Hassman Research Institute
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Synexus Clinical Research US, Inc.
City
New York
State/Province
New York
ZIP/Postal Code
10017
Country
United States
Individual Site Status
Terminated
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Individual Site Status
Terminated
Facility Name
Global Medical Institutes, LLC, Scranton Medical Institute
City
Moosic
State/Province
Pennsylvania
ZIP/Postal Code
18507
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
City
Caba
ZIP/Postal Code
C1133AAH
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
CEN (Centro Especializado Neurociencias)
City
Cordoba
ZIP/Postal Code
5004
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Instituto DAMIC - Fundacion Rusculleda
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
CENPIA-Centro de Estudios Neuropsiquiátricos y Psicológicos Integral Ambulatorio
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Clinica Privada de Salud Mental Santa Teresa de Avila
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Instituto de Neurociencias San Agustín
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Instituto Médico de la Fundación Estudios Clínicos
City
Rosario
ZIP/Postal Code
S2000DEJ
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
City
Rosario
ZIP/Postal Code
S2000QJI
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08002667801
Email
argentina@bitrialsupport.com
Facility Name
Griffith Health
City
Southport
State/Province
Queensland
ZIP/Postal Code
4125
Country
Australia
Individual Site Status
Completed
Facility Name
Peninsula Therapeutic and Research Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800271035
Email
australia@bitrialsupport.com
Facility Name
Albert Road Clinic
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800271035
Email
australia@bitrialsupport.com
Facility Name
Monash Alfred Psychiatry Research Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
1800271035
Email
australia@bitrialsupport.com
Facility Name
Mental Health Center "Prof. Dr. Ivan Temkov - Burgas" EOOD
City
Burgas
ZIP/Postal Code
9001
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
024903378
Email
balgariya@bitrialsupport.com
Facility Name
SPH "Sveti Ivan Rilsкi"
City
Novi Iskar
ZIP/Postal Code
1282
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
024903378
Email
balgariya@bitrialsupport.com
Facility Name
"Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
024903378
Email
balgariya@bitrialsupport.com
Facility Name
Medical Center Intermedica Ltd.
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
024903378
Email
balgariya@bitrialsupport.com
Facility Name
University of Calgary
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
OCT Research ULC
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
UBC Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2A1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
Braxia Scientific Corp. (CRTCE Mississauga)
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5C 4E7
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
Centre for Addiction and Mental Health (CAMH)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18336022346
Email
canada@bitrialsupport.com
Facility Name
Neuropsychiatry, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 09
Country
Czechia
Individual Site Status
Completed
Facility Name
Clinical Research Foundation s.r.o
City
Kladno
ZIP/Postal Code
27201
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
MPMeditrine s.r.o.
City
Ostrava-Poruba
ZIP/Postal Code
708 68
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
A-SHINE s.r.o
City
Plzen
ZIP/Postal Code
31200
Country
Czechia
Individual Site Status
Completed
Facility Name
Clintrial s.r.o.
City
Prague
ZIP/Postal Code
10000
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
AD71 s.r.o.
City
Prague
ZIP/Postal Code
10900
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
INEP medical s.r.o.
City
Prague
ZIP/Postal Code
18600
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800142046
Email
cesko@bitrialsupport.com
Facility Name
HOP Dijon-Bourgogne
City
Dijon
ZIP/Postal Code
21079
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
CAB Médical Psyché
City
Douai
ZIP/Postal Code
59500
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
CAB Ambroise Paré
City
Elancourt
ZIP/Postal Code
78990
Country
France
Individual Site Status
Completed
Facility Name
HOP la Colombière
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Saint-Jacques
City
Nantes
ZIP/Postal Code
44093
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Carémeau
City
Nîmes
ZIP/Postal Code
30029
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
CTR Psychiatrique Universitaire
City
Saint-Cyr-sur-Loire
ZIP/Postal Code
37540
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
HOP Purpan
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0805102354
Email
france@bitrialsupport.com
Facility Name
Zentrum für klinische Forschung Dr. med. I. Schöll
City
Bad Homburg
ZIP/Postal Code
61350
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Universitätsklinikum Frankfurt
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Individual Site Status
Completed
Facility Name
Zentralinstitut für seelische Gesundheit
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Praxis für Psychiatrie und Psychotherapie
City
Stralsund
ZIP/Postal Code
18439
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Studienzentrum Nord-West
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08007234742
Email
deutschland@bitrialsupport.com
Facility Name
Obudai Egeszsegugyi Centrum
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
680017725
Email
magyarorszag@bitrialsupport.com
Facility Name
Semmelweis University
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
680017725
Email
magyarorszag@bitrialsupport.com
Facility Name
Bugat Pal Hospital, Gyongyos
City
Gyongyos
ZIP/Postal Code
3200
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
680017725
Email
magyarorszag@bitrialsupport.com
Facility Name
National Center for Global Health and Medicine Kohnodai Hospital
City
Chiba, Ichikawa
ZIP/Postal Code
272-8516
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Kaku Mental Clinic
City
Fukuoka, Fukuoka
ZIP/Postal Code
810-0022
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Fukuoka University Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
814-0180
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Kuramitsu Hospital
City
Fukuoka, Fukuoka
ZIP/Postal Code
819-0037
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Hokudai-dori Mental Health Clinic
City
Hokkaido, Sapporo
ZIP/Postal Code
001-0010
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Arai Clinic
City
Hyogo, Amagasaki
ZIP/Postal Code
660-0882
Country
Japan
Individual Site Status
Completed
Facility Name
Tatsuta Clinic
City
Hyogo, Kobe
ZIP/Postal Code
651-0097
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Kishiro Mental Clinic
City
Kanagawa, Kawasaki
ZIP/Postal Code
214-0014
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Yutaka Clinic
City
Kanagawa,Sagamihara
ZIP/Postal Code
252-0303
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Yuge Neuropsychiatric Hospital
City
Kumamoto, Kumamoto
ZIP/Postal Code
861-8002
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Arata Clinic
City
Nagasaki, Nagasaki
ZIP/Postal Code
852-8154
Country
Japan
Individual Site Status
Completed
Facility Name
Nara Medical University Hospital
City
Nara, Kashihara
ZIP/Postal Code
634-8522
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Rainbow and Sea Hospital
City
Saga, Karatsu
ZIP/Postal Code
847-0031
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Inuo Hospital
City
Saga, Tosu
ZIP/Postal Code
841-0081
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
National Center of Neurology and Psychiatry
City
Tokyo, Kodaira
ZIP/Postal Code
187-8851
Country
Japan
Individual Site Status
Completed
Facility Name
Tamachi mita cocoromi Clinic
City
Tokyo, Minato-ku
ZIP/Postal Code
108-0023
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Sancha Mental Clinic
City
Tokyo, Setagaya-ku
ZIP/Postal Code
154-0004
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Maynds Tower Mental Clinic
City
Tokyo, Shibuya-ku
ZIP/Postal Code
151-0053
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Ichigaya Himorogi Clinic
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
162-0843
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Ohwa Mental Clinic
City
Tokyo, Toshima-ku
ZIP/Postal Code
170-0002
Country
Japan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Synexus Polska SCM Sp. z o.o. Gdansku, Gdansk
City
Gdansk
ZIP/Postal Code
80-382
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
Synexus Lodz Medical Center
City
Lodz
ZIP/Postal Code
90127
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
Specialist Psychiatric Healthcare Centre in Lodz
City
Lodz
ZIP/Postal Code
91-229
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
Clinical Best Solutions
City
Lublin
ZIP/Postal Code
20-078
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
Centrum Medyczne "Luxmed" Sp. z o.o.
City
Lublin
ZIP/Postal Code
20-109
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
Synexus Poland, Branch in Poznan
City
Poznan
ZIP/Postal Code
60-702
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008001218830
Email
polska@bitrialsupport.com
Facility Name
Federal State Budget Institution "Mental Health Research Center"
City
Moscow
ZIP/Postal Code
115522
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SBI of HC "Z. P. Solovyov Scientific&pract psychoneurolog.Cent"
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Individual Site Status
Completed
Facility Name
SHI "Reg.Clin.Psychiatric Hosp.of Saint Sophia"
City
Saratov
ZIP/Postal Code
410060
Country
Russian Federation
Individual Site Status
Completed
Facility Name
FSBEI of HE Smolensk State Medical University
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
SBHI "Psychiatric Hospital #1 P.P.Kashchenko"
City
St. Petersburg
ZIP/Postal Code
190121
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
FSBI Bekhterev Net.Med.Res.Cen.of Psych&Neuro
City
St. Petersburg
ZIP/Postal Code
192019
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
LLC "MK-Med"
City
St. Petersburg
ZIP/Postal Code
197373
Country
Russian Federation
Individual Site Status
Suspended
Facility Name
MUDr. Beata Dupejová
City
Banska Bystrica
ZIP/Postal Code
974 04
Country
Slovakia
Individual Site Status
Completed
Facility Name
J & J SMART, s.r.o., psychiatric clinic
City
Bratislava
ZIP/Postal Code
81107
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800002662
Email
slovensko@bitrialsupport.com
Facility Name
Old Town Bratislava University Hosp,
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800002662
Email
slovensko@bitrialsupport.com
Facility Name
MENTUM s.r.o.
City
Bratislava
ZIP/Postal Code
82007
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800002662
Email
slovensko@bitrialsupport.com
Facility Name
EPAMED s.r.o.
City
Kosice
ZIP/Postal Code
040 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800002662
Email
slovensko@bitrialsupport.com
Facility Name
Psychiatricka klinika I.UN L. Pasteura
City
Kosice
ZIP/Postal Code
4001
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800002662
Email
slovensko@bitrialsupport.com
Facility Name
CENTRUM ZDRAVIA R.B.K, s.r.o., psychiatric clinic
City
Svidnik
ZIP/Postal Code
089 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800002662
Email
slovensko@bitrialsupport.com
Facility Name
Pro mente sana s.r.o., Psychiatric clinic
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800002662
Email
slovensko@bitrialsupport.com
Facility Name
Crystal Comfort s.r.o
City
Vranov nad Toplou
ZIP/Postal Code
093 01
Country
Slovakia
Individual Site Status
Terminated
Facility Name
Hospital Universitario Fundación Alcorcón
City
Alcorcón
ZIP/Postal Code
28922
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Jerez de la Frontera
City
Jerez de la Frontera
ZIP/Postal Code
11407
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Puerta de Hierro
City
Majadahonda
ZIP/Postal Code
28222
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Centro de Salud de San Juan
City
Salamanca
ZIP/Postal Code
37005
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
900876092
Email
espana@bitrialsupport.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website. The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com
Description
Related Info

Learn more about this trial

A Study to Test the Effect of Different Doses of BI 1358894 and Quetiapine in People With Depression

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