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Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Iclepertin
Placebo
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Signed and dated written informed consent.
  • Male or female patients who are 18-50 years (inclusive) of age at time of consent.

  • Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5).

    -- Patients must be clinically stable and in the residual (non-acute) phase of their illness with no hospitalization or increase level of care due to worsening of schizophrenia in the past 12 weeks or no uncontrolled positive symptoms.

  • Patients should have functional impairment in day-to-day activities per investigator judgement.
  • Patients maintained on current antipsychotic treatment for at least 12 weeks and on current dose for at least 35 days prior to randomization.
  • Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization.
  • Women of childbearing potential must use highly effective methods of birth control.
  • Have a study partner who interacts with the patient on a regular basis. Further inclusion criteria apply.

Exclusion criteria

  • Patient with current DSM-5 diagnosis other than Schizophrenia.
  • Cognitive impairment due to other causes, or patients with dementia.
  • Severe movement disorders.
  • Any suicidal behavior in past year or suicidal ideation in the past 3 months.
  • History of moderate or severe substance use disorder within the last 12 months prior to informed consent.
  • Positive urine drug screen.
  • Patients who were treated with Clozapine, stimulants, ketamine or electroconvulsive therapy within 6 months prior to randomization.
  • Current participation in any investigational drug trial.
  • Cognitive Remediation Therapy within 12 weeks prior to screening.
  • Initiation or change in any type or frequency of psychotherapy within 12 weeks prior to randomization.
  • Any clinically significant finding or condition that would jeopardize the patient´s safety while participating in the trial or their capability to participate in the trial.
  • Haemoglobin (Hb) below lower limit of normal .
  • History of haemolytic anaemia, red blood cell (RBC) membrane diseases, known Glucose-6-phosphate dehydrogenase deficiency, anaemia of any cause or patients planning to donate blood.
  • Severe renal impairment.
  • Indication of liver disease.
  • Any documented active or suspected malignancy or history of malignancy within 5 years.
  • Women who are pregnant, nursing, or who plan to become pregnant while in the trial.

Further exclusion criteria apply.

Sites / Locations

  • Collaborative Neuroscience Network, LLC (CNS)Recruiting
  • Omega Clinical Trials,LLCRecruiting
  • Artemis Institute for Clinical Research, LLCRecruiting
  • Velocity Clinical ResearchRecruiting
  • Institute of LivingRecruiting
  • Vertex Research GroupRecruiting
  • San Marcus Research Clinic, Inc.Recruiting
  • CCM Clinical Research Group, LLCRecruiting
  • Atlanta CenterRecruiting
  • University at Buffalo, The State University of New YorkRecruiting
  • Richmond Behavioral AssociatesRecruiting
  • University of CincinnatiRecruiting
  • North Star Medical Research, LLCRecruiting
  • Neuro-Behavioral Clinical ResearchRecruiting
  • PeaceHealth Medical GroupRecruiting
  • Community Clinical Research, Inc.Recruiting
  • InSite Clinical ResearchRecruiting
  • North Texas Clinical TrialsRecruiting
  • Houston Mind and BrainRecruiting
  • Core Clinical ResearchRecruiting
  • Monash Medical CentreRecruiting
  • Monash Alfred Psychiatry Research CentreRecruiting
  • Hospital das Clinicas da Universidade Federal HC-UFMGRecruiting
  • CPN - Centro de Estudos em NeurociênciasRecruiting
  • Hospital Sao JoseRecruiting
  • Trial Tech- Tecnologia em pesquisa com medicamentosRecruiting
  • J A Serviços Médicos Ltda/ Instituto Goiano de NeuropisquiatriaRecruiting
  • Hospital de Base - Fac Med de Sao Jose do Rio PretoRecruiting
  • BR TrialsRecruiting
  • University of CalgaryRecruiting
  • OCT Research ULCRecruiting
  • Centre for Addiction and Mental Health (CAMH)Recruiting
  • The sixth People's Hospital of Hebei ProvinceRecruiting
  • Peking University Sixth HospitalRecruiting
  • Beijing HuiLongGuan HospitalRecruiting
  • Brain hospital of Hunan provinceRecruiting
  • The Affiliated Brain Hospital of Guangzhou Medical UniversityRecruiting
  • The Affiliated Hospital of Guizhou Medical UniversityRecruiting
  • Shandong Daizhuang HospitalRecruiting
  • The First Affilliated Hospital Of Kunming of Medical CollegeRecruiting
  • Ningbo Kangning HospitalRecruiting
  • Shanghai Mental Health CenterRecruiting
  • Tongji Hospital, Tongji UniversityRecruiting
  • Wuxi mental health centerRecruiting
  • The Second Affiliated Hospital of Xinxiang Medical Univ.Recruiting
  • Centro de Investigación y Proyectos en neurociencia CIPNARecruiting
  • E.S.E Hospital Mental de AntioquiaRecruiting
  • Instituto Colombiano del Sistema Nervioso- Clínica MontserratRecruiting
  • Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SASRecruiting
  • Psynapsis Salud Mental S.A.Recruiting
  • Zentrum für klinische Forschung Dr. med. I. SchöllRecruiting
  • Praxis Dr. Hahn, BerlinRecruiting
  • Zentralinstitut für seelische GesundheitRecruiting
  • Neurologie und Psychiatrie / PsychotherapieRecruiting
  • Eginition HospitalRecruiting
  • "Attikon" University General Hospital of AtticaRecruiting
  • Psychiatric Hospital of AtticaRecruiting
  • AX Mental Health ClinicRecruiting
  • General Oncology Hospital "Agioi Anargyri"Recruiting
  • University General Hospital of Thessaloniki AHEPARecruiting
  • General Hospital of Thessaloniki "G. Papanikolaou"Recruiting
  • ASST degli Spedali Civili di BresciaRecruiting
  • USL5 di LecceRecruiting
  • A.O. FatebenefratelliRecruiting
  • Ist. San Raffaele TurroRecruiting
  • Azienda Sanitaria Ospedale S. Luigi GonzagaRecruiting
  • IRCCS Fondazione Santa LuciaRecruiting
  • A.O.U. Senese Policlinico Santa Maria alle ScotteRecruiting
  • Hotei HospitalRecruiting
  • National Center for Global Health and Medicine Kohnodai HospitalRecruiting
  • Mental Clinic SakurazakaRecruiting
  • Fukuoka University HospitalRecruiting
  • Kuramitsu HospitalRecruiting
  • Shiranui HospitalRecruiting
  • Obihiro-Kosei General HospitalRecruiting
  • Hokkaido University HospitalRecruiting
  • Kagawa University HospitalRecruiting
  • St. Marianna University HospitalRecruiting
  • Kitasato University HospitalRecruiting
  • Yokohama Onoecho ClinicRecruiting
  • Hino HospitalRecruiting
  • Kochi Health Sciences CenterRecruiting
  • National Hospital Organization Maizuru Medical CenterRecruiting
  • Tohoku University HospitalRecruiting
  • Shounan HospitalRecruiting
  • Niigata University Medical and Dental HospitalRecruiting
  • National Hospital Organization Hizen Psychiatric Medical CenterRecruiting
  • Saitama Medical University HospitalRecruiting
  • Nishi Kumagaya HospitalRecruiting
  • Dokkyo Medical University HospitalRecruiting
  • Tokushima University HospitalRecruiting
  • National Center of Neurology and PsychiatryRecruiting
  • Asuka HospitalRecruiting
  • Showa University Karasuyama HospitalRecruiting
  • Shinjuku East Mental ClinicRecruiting
  • Ohwa Mental ClinicRecruiting
  • Yamaguchi University HospitalRecruiting
  • University of Yamanashi HospitalRecruiting
  • GabiPros S.C.Recruiting
  • Instituto Nacional de Neurologia y NeurocirugiaRecruiting
  • Clinica CemelliRecruiting
  • Medical Care & Research SA de CVRecruiting
  • CIT-Neuropsique S.CRecruiting
  • Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME).Recruiting
  • CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf CardiovascRecruiting
  • North Shore Hospital, TakapunaRecruiting
  • Sykehuset Østfold HF, avd. MossRecruiting
  • Akershus Universitetssykehus HFRecruiting
  • St. Paul's HospitalRecruiting
  • Makati Medical CenterRecruiting
  • Philippine General HospitalRecruiting
  • Podlassian Center of Psychogeriatry, BialystokRecruiting
  • Central Teaching Hospital of the Medical University of LodzRecruiting
  • Clinical Best SolutionsRecruiting
  • Individual Specialist Medical Practice Filip RybakowskiRecruiting
  • Institute of Psychiatry and Neurology in WarsawRecruiting
  • ClinhouseRecruiting
  • Psykiatriska KlinikenRecruiting
  • Akademiska sjukhusetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Iclepertin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) after 26 weeks of treatment
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition

Secondary Outcome Measures

Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score after 26 weeks of treatment
SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functioning. Each item is rated on a 4-point scale. Higher ratings reflect a greater degree of impairment.
Change from baseline to Week 26 in the adjusted total time T-score in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London (ToL) test
Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score
PRECIS is a patient reported outcome (PRO) for recording patients' subjective experience of Cognitive Impairment Associated with Schizophrenia (CIAS). The questionnaire contains 28 items covering 6 domains: Memory (6 items), communication (4 items), self-control (3 items), executive function (4 items), attention (6 items), and sharp thinking (3 items). Two additional items assess the overall degree of bother associated with all domains. Questions are answered via a 5-category Likert scale, with higher scores corresponding to worse patient experience. The Total Score is derived by calculating the simple average score of the first 26 items.

Full Information

First Posted
April 13, 2021
Last Updated
September 22, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04846868
Brief Title
Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)
Official Title
A Phase III Randomized, Double-blind, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of Iclepertin Once Daily Over 26 Week Treatment Period in Patients With Schizophrenia (CONNEX-1)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2021 (Actual)
Primary Completion Date
January 3, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (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 schizophrenia. Schizophrenia can affect the way a person thinks, their memory and their mental functioning. Examples include struggling to remember things, or to read a book or pay attention to a movie. Some people have difficulty calculating the right change or planning a trip so that they arrive on time. The purpose of this study is to find out whether a medicine called Iclepertin improves learning and memory in people with schizophrenia. Participants are put into two groups randomly, which means by chance. One group takes Iclepertin tablets and the other group takes placebo tablets. Placebo tablets look like Iclepertin tablets but do not contain any medicine. Participants take a tablet once a day for 26 weeks. In addition, all participants take their normal medication for schizophrenia. During this time, doctors regularly test learning and memory of the participants by use of questionnaires, interviews, and computer tests. The results of the mental ability tests are compared between the groups. Participants are in the study for about 8 months and visit the study site about 14 times. During this time, doctors regularly check participants' health and take note of any unwanted effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
586 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Iclepertin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Iclepertin
Intervention Description
Iclepertin
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Change from baseline in overall composite T-score of the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) Consensus Cognitive Battery (MCCB) after 26 weeks of treatment
Description
MCCB comprises 10 tests, which assess 7 cognitive domains, including speed of processing, attention vigilance, working memory, verbal learning, visual learning, reasoning and problem solving, and social cognition
Time Frame
at baseline and at week 26
Secondary Outcome Measure Information:
Title
Change from baseline in the Schizophrenia Cognition Rating Scale (SCoRS) interviewer total score after 26 weeks of treatment
Description
SCoRS is a 20-item interview-based assessment of cognitive deficits and the degree to which they affect day-to-day functioning. Each item is rated on a 4-point scale. Higher ratings reflect a greater degree of impairment.
Time Frame
at baseline and at week 26
Title
Change from baseline to Week 26 in the adjusted total time T-score in the Virtual Reality Functional Capacity Assessment Tool (VRFCAT)
Time Frame
at baseline and at week 26
Title
Change from baseline to Week 26 in the T-score of the number of correct responses on Tower of London (ToL) test
Time Frame
at baseline and at week 26
Title
Change from screening visit 1a to Week 24 in Patient Reported Experience of Cognitive Impairment in Schizophrenia (PRECIS) total score
Description
PRECIS is a patient reported outcome (PRO) for recording patients' subjective experience of Cognitive Impairment Associated with Schizophrenia (CIAS). The questionnaire contains 28 items covering 6 domains: Memory (6 items), communication (4 items), self-control (3 items), executive function (4 items), attention (6 items), and sharp thinking (3 items). Two additional items assess the overall degree of bother associated with all domains. Questions are answered via a 5-category Likert scale, with higher scores corresponding to worse patient experience. The Total Score is derived by calculating the simple average score of the first 26 items.
Time Frame
up to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patients must be capable of providing signed and dated written informed consent by date of Visit 1 in accordance with ICH Harmonized Tripartite Guideline for Good Clinical Practice (ICH-GCP) and the local legislation prior to the admission to the trial. Male or female patients who are 18-50 years (inclusive) of age at time of consent. Diagnosis of schizophrenia utilizing Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5) with the following clinical features: Outpatient, clinically stable and in the residual (non-acute) phase of their illness. No hospitalization or increase in level of psychiatric care due to worsening of schizophrenia within 12 weeks prior to randomization. Positive and Negative Syndrome Scale (PANSS) score: items P1, P3-P6 ≤ 5 and item P2 and P7 ≤ 4 at Visit 1, and confirmed at Visit 2. Patients should have functional impairment in day-to-day activities such as difficulties following conversation or expressing themselves, difficulties to stay focused, difficulties to remember instructions, what to say or how to get to places, per investigator judgement. Patients maintained on current antipsychotic treatment (minimum 1 and maximum 2 antipsychotics, but clozapine is not allowed) for at least 12 weeks and on current dose for at least 35 days prior to randomization. -- For patients on two antipsychotics, at least one antipsychotic must be within the approved label dose range. The second antipsychotic must not exceed the maximum daily dose per local label. Note: If the total dose is stable, different dosage forms of the same antipsychotic treatment will be considered as one antipsychotic. Patients with any other concomitant psychoactive medications (except for anticholinergics) need to be maintained on same drug for at least 12 weeks and on current dose/ regimen for at least 35 days prior to randomization. Maximum daily benzodiazepine load of up to 1 mg lorazepam-equivalent. For any other psychoactive medications, doses cannot exceed the maximum daily dose per local label. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per Non-Clinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals (ICH M3 (R2)) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the protocol. Such methods should be used throughout the trial, and for a period of at least 35 days after last trial drug intake, and the patient must agree to periodic pregnancy testing during participation in the trial. Have a study partner, defined as any person either private or professional who knows the patient well, has been capable of interacting with the patient on regular basis, and preferably consistent throughout the study. The study partner must interact with the subject a minimum 1 hour per week and, preferably, at least 2 times a week. At least one interaction per week should be in person. The study partner must have educational achievement of minimum 8th grade. Professional study partners (e.g. study nurse, social worker etc.) are allowed if not involved in administration of any of the protocol assessments. Further inclusion criteria apply. Exclusion criteria Participant with current DSM-5 diagnosis other than Schizophrenia, including but not limited to bipolar, schizoaffective, major depressive disorder etc. Mini International Neuropsychiatric Interview (M.I.N.I.) for Psychotic disorders should be used for guidance. Cognitive impairment due to developmental, neurological (e.g., epilepsy, stroke) or other disorders including head trauma, or patients with dementia or epilepsy. Severe movement disorders Leading to cognitive impairment (e.g. Parkinson dementia), or Interfering with the efficacy assessments, or Due to antipsychotic treatment that cannot be controlled with low dose anticholinergic treatment (equal to maximum 1 mg benztropine twice daily). Any suicidal behavior in the past 1-year prior to screening and during the screening period. Suicidal ideation of type 5 in the Columbia Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with plan and intent) in the past 3 months prior to screening and up to and including Visit 2. -- Patients with Suicidal Ideation type 4 in the C-SSRS (i.e. active suicidal thought with intent but without specific plan), within 3 months prior to screening and up to and including Visit 2, can be randomized in the study, if assessed and documented by a licensed mental health professional that there is no immediate risk of suicide. History of moderate or severe substance use disorder (other than caffeine and nicotine), as defined in DSM-5 within the last 12 months prior to informed consent. Positive urine drug screen at Visit 1 based on central lab test. Patients who were treated with any of the following within 6 months prior to randomization: Clozapine Stimulants (e.g. methylphenidate, dextroamphetamine, modafinil) Ketamine or esketamine Electroconvulsive therapy (ECT) or Modified ECT Further exclusion criteria apply.
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
Collaborative Neuroscience Network, LLC (CNS)
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
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
Omega Clinical Trials,LLC
City
La Habra
State/Province
California
ZIP/Postal Code
90631
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
Artemis Institute for Clinical Research, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92103
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
Velocity Clinical Research
City
Santa Ana
State/Province
California
ZIP/Postal Code
92704
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
61060
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
Vertex Research Group
City
Clermont
State/Province
Florida
ZIP/Postal Code
34711
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
San Marcus Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
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
CCM Clinical Research Group, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33133
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
833-602-2368
Email
unitedstates@bitrialsupport.com
Facility Name
University at Buffalo, The State University of New York
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
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
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10314
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 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
North Star Medical Research, LLC
City
Middleburg Heights
State/Province
Ohio
ZIP/Postal Code
44130
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
Neuro-Behavioral Clinical Research
City
North Canton
State/Province
Ohio
ZIP/Postal Code
44720
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
PeaceHealth Medical Group
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
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
Community Clinical Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78754
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
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
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
North Texas Clinical Trials
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
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
Houston Mind and Brain
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
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
Monash Medical Centre
City
Clayton
State/Province
Victoria
ZIP/Postal Code
3168
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
Hospital das Clinicas da Universidade Federal HC-UFMG
City
Belo Horizonte,Minas Gerais
ZIP/Postal Code
31270901
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
CPN - Centro de Estudos em Neurociências
City
Belo Horizonte
ZIP/Postal Code
30150-270
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
Hospital Sao Jose
City
Criciuma
ZIP/Postal Code
88801250
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
Trial Tech- Tecnologia em pesquisa com medicamentos
City
Curitiba
ZIP/Postal Code
80.240-280
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
J A Serviços Médicos Ltda/ Instituto Goiano de Neuropisquiatria
City
Goiania
ZIP/Postal Code
74093-040
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
Hospital de Base - Fac Med de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@bitrialsupport.com
Facility Name
BR Trials
City
Sao Paulo
ZIP/Postal Code
05003090
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
08008919295
Email
brasil@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
Centre for Addiction and Mental Health (CAMH)
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6J 1H3
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
The sixth People's Hospital of Hebei Province
City
Baoding
ZIP/Postal Code
71000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Peking University Sixth Hospital
City
Beijing
ZIP/Postal Code
100089
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Beijing HuiLongGuan Hospital
City
Beijing
ZIP/Postal Code
100096
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Brain hospital of Hunan province
City
Changsha
ZIP/Postal Code
410007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The Affiliated Brain Hospital of Guangzhou Medical University
City
Guangzhou
ZIP/Postal Code
510370
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The Affiliated Hospital of Guizhou Medical University
City
Guiyang
ZIP/Postal Code
550004
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Shandong Daizhuang Hospital
City
Jining
ZIP/Postal Code
272051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The First Affilliated Hospital Of Kunming of Medical College
City
Kunming
ZIP/Postal Code
650032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Ningbo Kangning Hospital
City
Ningbo
ZIP/Postal Code
315201
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Shanghai Mental Health Center
City
Shanghai
ZIP/Postal Code
200030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Tongji Hospital, Tongji University
City
Shanghai
ZIP/Postal Code
200065
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Wuxi mental health center
City
Wuxi
ZIP/Postal Code
214151
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
The Second Affiliated Hospital of Xinxiang Medical Univ.
City
Xinxiang
ZIP/Postal Code
453002
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
4001200553
Email
china@bitrialsupport.com
Facility Name
Centro de Investigación y Proyectos en neurociencia CIPNA
City
Barranquilla
ZIP/Postal Code
80020
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18005190813
Email
colombia@bitrialsupport.com
Facility Name
E.S.E Hospital Mental de Antioquia
City
Bello
ZIP/Postal Code
51053
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18005190813
Email
colombia@bitrialsupport.com
Facility Name
Instituto Colombiano del Sistema Nervioso- Clínica Montserrat
City
Bogota
ZIP/Postal Code
110121
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18005190813
Email
colombia@bitrialsupport.com
Facility Name
Centro de Investigaciones del Sistema Nervioso SAS- Grupo Cisne SAS
City
Bogotá
ZIP/Postal Code
111166
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18005190813
Email
colombia@bitrialsupport.com
Facility Name
Psynapsis Salud Mental S.A.
City
Pereira
ZIP/Postal Code
660003
Country
Colombia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
18005190813
Email
colombia@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
Praxis Dr. Hahn, Berlin
City
Berlin
ZIP/Postal Code
13187
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
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
Neurologie und Psychiatrie / Psychotherapie
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
Eginition Hospital
City
Athens
ZIP/Postal Code
11528
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008000000092
Email
hellas@bitrialsupport.com
Facility Name
"Attikon" University General Hospital of Attica
City
Chaidari
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008000000092
Email
hellas@bitrialsupport.com
Facility Name
Psychiatric Hospital of Attica
City
Haidari
ZIP/Postal Code
12462
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008000000092
Email
hellas@bitrialsupport.com
Facility Name
AX Mental Health Clinic
City
Heraclion
ZIP/Postal Code
71305
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008000000092
Email
hellas@bitrialsupport.com
Facility Name
General Oncology Hospital "Agioi Anargyri"
City
Nea Kifisia
ZIP/Postal Code
14564
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008000000092
Email
hellas@bitrialsupport.com
Facility Name
University General Hospital of Thessaloniki AHEPA
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008000000092
Email
hellas@bitrialsupport.com
Facility Name
General Hospital of Thessaloniki "G. Papanikolaou"
City
Thessaloniki
ZIP/Postal Code
57 010
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
008000000092
Email
hellas@bitrialsupport.com
Facility Name
ASST degli Spedali Civili di Brescia
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
USL5 di Lecce
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
A.O. Fatebenefratelli
City
Milano
ZIP/Postal Code
20121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
Ist. San Raffaele Turro
City
Milano
ZIP/Postal Code
20127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
Azienda Sanitaria Ospedale S. Luigi Gonzaga
City
Orbassano (to)
ZIP/Postal Code
10043
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
IRCCS Fondazione Santa Lucia
City
Roma
ZIP/Postal Code
00179
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
A.O.U. Senese Policlinico Santa Maria alle Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
800977373
Email
italia@bitrialsupport.com
Facility Name
Hotei Hospital
City
Aichi, Konan
ZIP/Postal Code
483-8248
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 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
Mental Clinic Sakurazaka
City
Fukuoka, Fukuoka
ZIP/Postal Code
810-0023
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
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
Shiranui Hospital
City
Fukuoka, Omuta
ZIP/Postal Code
836-0004
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
Obihiro-Kosei General Hospital
City
Hokkaido, Obihiro
ZIP/Postal Code
080-0024
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
Hokkaido University Hospital
City
Hokkaido, Sapporo
ZIP/Postal Code
060-8648
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
Kagawa University Hospital
City
Kagawa, Kita-gun
ZIP/Postal Code
761-0793
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
St. Marianna University Hospital
City
Kanagawa, Kawasaki
ZIP/Postal Code
216-8511
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
Kitasato University Hospital
City
Kanagawa, Sagamihara
ZIP/Postal Code
252-0375
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
Yokohama Onoecho Clinic
City
Kanagawa, Yokohama
ZIP/Postal Code
231-0015
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
Hino Hospital
City
Kanagawa, Yokohama
ZIP/Postal Code
234-0051
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
Kochi Health Sciences Center
City
Kochi, Kochi
ZIP/Postal Code
781-8555
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 Hospital Organization Maizuru Medical Center
City
Kyoto, Maizuru
ZIP/Postal Code
625-8502
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
Tohoku University Hospital
City
Miyagi, Sendai
ZIP/Postal Code
980-8574
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
Shounan Hospital
City
Nagano, Matsumoto
ZIP/Postal Code
390-0847
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
Niigata University Medical and Dental Hospital
City
Niigata, Niigata
ZIP/Postal Code
951-8520
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 Hospital Organization Hizen Psychiatric Medical Center
City
Saga, Kanzaki-gun
ZIP/Postal Code
842-0192
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
Saitama Medical University Hospital
City
Saitama, Iruma-gun
ZIP/Postal Code
350-0495
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
Nishi Kumagaya Hospital
City
Saitama, Kumagaya
ZIP/Postal Code
360-0816
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
Dokkyo Medical University Hospital
City
Tochigi, Shimotsuga-gun
ZIP/Postal Code
321-0293
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
Tokushima University Hospital
City
Tokushima, Tokushima
ZIP/Postal Code
770-8503
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
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0120201230
Email
nippon@bitrialsupport.com
Facility Name
Asuka Hospital
City
Tokyo, Machida
ZIP/Postal Code
194-0005
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
Showa University Karasuyama Hospital
City
Tokyo, Setagaya
ZIP/Postal Code
157-8577
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
Shinjuku East Mental Clinic
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
160-0022
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
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
Yamaguchi University Hospital
City
Yamaguchi, Ube
ZIP/Postal Code
755-8505
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
University of Yamanashi Hospital
City
Yamanashi, Chuo
ZIP/Postal Code
409-3898
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
GabiPros S.C.
City
Cdmx
ZIP/Postal Code
07810
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Instituto Nacional de Neurologia y Neurocirugia
City
Ciudad de Mexico
ZIP/Postal Code
14269
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Clinica Cemelli
City
Guadalajara
ZIP/Postal Code
44100
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Medical Care & Research SA de CV
City
Merida
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
CIT-Neuropsique S.C
City
Monterrey
ZIP/Postal Code
64610
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
Instituto de Informacion e Investigacion en Salud Mental A.C. (INFOSAME).
City
Monterrey
ZIP/Postal Code
64710
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
CEDOPEC-Ctro Esp en Diab, Obesidad y Prev de Enf Cardiovasc
City
México
ZIP/Postal Code
C.P. 11650
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
018000623749
Email
mexico@bitrialsupport.com
Facility Name
North Shore Hospital, Takapuna
City
Takpuna Auckland
ZIP/Postal Code
0622
Country
New Zealand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0800440725
Email
newzealand@bitrialsupport.com
Facility Name
Sykehuset Østfold HF, avd. Moss
City
Moss
ZIP/Postal Code
N-1535
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80058261
Email
norge@bitrialsupport.com
Facility Name
Akershus Universitetssykehus HF
City
Oslo
ZIP/Postal Code
N-0963
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
80058261
Email
norge@bitrialsupport.com
Facility Name
St. Paul's Hospital
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
180084748502
Email
pilipinas@bitrialsupport.com
Facility Name
Makati Medical Center
City
Makati City
ZIP/Postal Code
1229
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
180084748502
Email
pilipinas@bitrialsupport.com
Facility Name
Philippine General Hospital
City
Manila, Philippines
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
180084748502
Email
pilipinas@bitrialsupport.com
Facility Name
Podlassian Center of Psychogeriatry, Bialystok
City
Bialystok
ZIP/Postal Code
15-756
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
Central Teaching Hospital of the Medical University of Lodz
City
Lodz
ZIP/Postal Code
92-216
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
Individual Specialist Medical Practice Filip Rybakowski
City
Poznan
ZIP/Postal Code
60-744
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
Institute of Psychiatry and Neurology in Warsaw
City
Warsaw
ZIP/Postal Code
02-957
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
Clinhouse
City
Zabrze
ZIP/Postal Code
41-807
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
Psykiatriska Kliniken
City
Helsingborg
ZIP/Postal Code
201 53
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0200880001
Email
sverige@bitrialsupport.com
Facility Name
Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim
Phone
0200880001
Email
sverige@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
http://www.mystudywindow.com
Description
Related Info

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Clinical Trial of Iclepertin Effect on Cognition and Functional Capacity in Schizophrenia (CONNEX-1)

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