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A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder

Primary Purpose

Borderline Personality Disorder

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

About this trial

This is an interventional treatment trial for Borderline Personality Disorder

Eligibility Criteria

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

Inclusion Criteria:

  • Patients meeting diagnostic criteria of borderline personality disorder (BoPD) per Diagnostic and Statistical Manual of Mental Disorders(DSM-5) at screening visit, confirmed by Structured Interview for DSM-5 Personality Disorder (SCID-5-PD).
  • Zanarini rating scale for Borderline personality disorder (ZAN-BPD) of ≥ 9 at screening (Visit 1) and randomization (Visit 2), with question #2 Affective Instability score of ≥2.
  • Male or female patients, 18-65 years of age at the time of consent

  • Women of childbearing potential (WOCBP) able and willing to use two methods of contraception, as confirmed by the investigator, which include one highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1%, plus one barrier method.

    --A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal occlusion/ ligation is NOT a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.

  • Signed and dated written informed consent in accordance with International Council on Harmonization (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial.
  • further inclusion criteria apply.

Exclusion Criteria:

  • Current diagnosis of paranoid, schizoid, schizotypal and antisocial personality disorders, as confirmed by SCID-5-PD at screening visit.
  • Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, or delusional disorder as confirmed by the SCID-5 at the screening visit.
  • Any other mental disorder that is the primary focus of treatment in the last 6 months prior to randomization, as per the clinical judgement of the investigator.
  • Inpatient stay or hospitalization due to worsening of BoPD within 3 months prior to randomization.
  • Initiation or change in any type or frequency of psychotherapy for BoPD within the last 3 months prior to screening.
  • Any ongoing use of psychotropic medications within 7 days prior to randomization or during the course of study.
  • Any suicidal behavior in the past 1 year.
  • Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months.
  • further exclusion criteria apply.

Sites / Locations

  • Advanced Research Center, Inc.
  • Viking Clinical Research, Ltd.
  • Pacific Clinical Research Management Group LLC
  • Yale University School of Medicine
  • Gulf Coast Clinical Research Center
  • Sarkis Clinical Trials
  • San Marcus Research Clinic, Inc.
  • Institute for Advanced Medical Research
  • McLean Hospital
  • Precise Research Centers
  • Center For Emotional Fitness
  • University at Buffalo, The State University of New York
  • Neurobehavioral Research, Inc.
  • Central States Research, LLC
  • Grayline Research Center
  • Core Clinical Research
  • Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
  • Fundación FunDaMos para la asistencia e investigación en psiquiatría
  • CEN (Centro Especializado Neurociencias)
  • Instituto Médico DAMIC S.R.L.
  • Instituto Modelo de Neurología Lennox
  • Clinica Privada de Salud Mental Santa Teresa de Avila
  • Instituto de Neurociencias San Agustín
  • Instituto Médico de la Fundación Estudios Clínicos
  • Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
  • Peninsula Therapeutic and Research Group
  • Monash Alfred Psychiatry Research Centre
  • Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
  • "Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry
  • University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD
  • Medical Center Intermedica Ltd.
  • MPMeditrine s.r.o.
  • Clintrial s.r.o.
  • INEP medical s.r.o.
  • Aalborg Universitetsshospital
  • Region Zealand, Psychiatric Research Unit
  • HOP Pierre Wertheimer
  • HOP la Colombière
  • Universitätsklinikum Aachen, AöR
  • Charité - Universitätsmedizin Berlin
  • Universitätsklinikum Bonn AöR
  • Universitätsklinikum Gießen und Marburg GmbH
  • Zentralinstitut für seelische Gesundheit
  • Klinikum der Universität München - Campus Innenstadt
  • Universitätsklinikum Tübingen
  • IRCCS San Giovanni Di Dio Fatebenefratelli
  • Kokoro no Clinic Hirao
  • Hirota Clinic
  • Kishiro Mental Clinic
  • Hiyoshi Hospital
  • Nara Medical University Hospital
  • i Kokoro Clinic Nihonbashi
  • Ichigaya Himorogi Clinic
  • GabiPros S.C.
  • Medical Care & Research SA de CV
  • Hospital Universitario Dr Jose Eleuterio Gonzalez
  • CIT-Neuropsique S.C
  • Centro de Estudios Clinicos de Queretaro S.C
  • BIND Investigaciones S.C.
  • Podlassian Center of Psychogeriatry, Bialystok
  • PI HOUSE Sp. z o.o., Gdansk
  • Hospital Universitario Marqués de Valdecilla
  • Hospital Virgen del Rocío
  • CS Casa del Barco
  • Psykiatri Södra Stockholm
  • Sahlgrenska Universitetssjukhuset, Östra
  • Akademiska sjukhuset

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

BI 1358894 dose group 1

Placebo

BI 1358894 dose group 2

BI 1358894 dose group 3

BI 1358894 dose group 4

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in Zanarini rating scale for Borderline personality disorder (ZAN-BPD) total score at Week 10
The ZAN-BPD scale reflects the nine disease criteria with each one rated on a 5-point rating scale. The total ZAN-BPD score ranges from 0 to 36 with higher scores reflecting greater levels of symptoms. The ZAN-BPD scale is administered as an interview.

Secondary Outcome Measures

Response defined as ≥30% ZAN-BPD reduction from baseline at Week 10.
The ZAN-BPD scale reflects the nine disease criteria with each one rated on a 5-point rating scale. The total ZAN-BPD score ranges from 0 to 36 with higher scores reflecting greater levels of symptoms. The ZAN-BPD scale is administered as an interview.
Change from baseline in Difficulties in Emotion Regulation Scale (DERS-16) total score at Week 10
The DERS-16 total score ranges from 16 to 80 with higher scores reflecting greater levels of emotional dysregulation.
Change from baseline in State-Trait Anxiety Inventory (STAI-S) total score at Week 10.
The STAI-S total score ranges from 20 to 80 with higher scores indicating higher anxiety.
Change from baseline in Patient Health Questionnaire (PHQ-9) total score at Week 10.
The PHQ-9 total score ranges from 0 to 27 with higher scores indicating higher depression severity.
Change from baseline in Clinical Global Impression Severity scale (CGI-S) at Week 10
The CGI-S score ranges from 1 to 7 with higher scores indicating worsening of the patient's illness.
Change from baseline in Patient Global Impression Severity scale (PGI-S) at Week 10.
The PGI-S score ranges from 1 to 5 with higher scores indicating worsening of the patients's symptoms.

Full Information

First Posted
September 23, 2020
Last Updated
August 2, 2023
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT04566601
Brief Title
A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder
Official Title
A Phase II Randomized, Double-blinded, Placebo-controlled Parallel Group Trial to Examine the Efficacy and Safety of 4 Oral Doses of BI 1358894 Once Daily Over 12 Week Treatment Period in Patients With Borderline Personality Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
November 13, 2020 (Actual)
Primary Completion Date
December 9, 2022 (Actual)
Study Completion Date
January 25, 2023 (Actual)

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 borderline personality disorder. The purpose of this study is to find out whether a medicine called BI 1358894 helps to reduce symptoms in people with borderline personality disorder. Four different doses of BI 1358894 are tested in the study. Participants are put into 5 groups by chance. Participants in 4 of the 5 groups take different doses of BI 1358894. Participants in the fifth group take placebo. Participants take BI 1358894 and placebo as tablets once a day. Placebo tablets look like BI 1358894 tablets but do not contain any medicine. Participants are in the study for about 5 months. During this time, they visit the study site about 12 times and get about 6 phone calls. At the visits, doctors ask participants about their symptoms. The results between the BI 1358894 groups 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
Borderline Personality Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
390 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BI 1358894 dose group 1
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
BI 1358894 dose group 2
Arm Type
Experimental
Arm Title
BI 1358894 dose group 3
Arm Type
Experimental
Arm Title
BI 1358894 dose group 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
BI 1358894
Intervention Description
Film-coated tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Film-coated tablet
Primary Outcome Measure Information:
Title
Change from baseline in Zanarini rating scale for Borderline personality disorder (ZAN-BPD) total score at Week 10
Description
The ZAN-BPD scale reflects the nine disease criteria with each one rated on a 5-point rating scale. The total ZAN-BPD score ranges from 0 to 36 with higher scores reflecting greater levels of symptoms. The ZAN-BPD scale is administered as an interview.
Time Frame
Baseline and week 10
Secondary Outcome Measure Information:
Title
Response defined as ≥30% ZAN-BPD reduction from baseline at Week 10.
Description
The ZAN-BPD scale reflects the nine disease criteria with each one rated on a 5-point rating scale. The total ZAN-BPD score ranges from 0 to 36 with higher scores reflecting greater levels of symptoms. The ZAN-BPD scale is administered as an interview.
Time Frame
Baseline and week 10
Title
Change from baseline in Difficulties in Emotion Regulation Scale (DERS-16) total score at Week 10
Description
The DERS-16 total score ranges from 16 to 80 with higher scores reflecting greater levels of emotional dysregulation.
Time Frame
Baseline and week 10
Title
Change from baseline in State-Trait Anxiety Inventory (STAI-S) total score at Week 10.
Description
The STAI-S total score ranges from 20 to 80 with higher scores indicating higher anxiety.
Time Frame
Baseline and week 10
Title
Change from baseline in Patient Health Questionnaire (PHQ-9) total score at Week 10.
Description
The PHQ-9 total score ranges from 0 to 27 with higher scores indicating higher depression severity.
Time Frame
Baseline and week 10
Title
Change from baseline in Clinical Global Impression Severity scale (CGI-S) at Week 10
Description
The CGI-S score ranges from 1 to 7 with higher scores indicating worsening of the patient's illness.
Time Frame
Baseline and week 10
Title
Change from baseline in Patient Global Impression Severity scale (PGI-S) at Week 10.
Description
The PGI-S score ranges from 1 to 5 with higher scores indicating worsening of the patients's symptoms.
Time Frame
Baseline and week 10

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: Patients meeting diagnostic criteria of borderline personality disorder (BoPD) per Diagnostic and Statistical Manual of Mental Disorders(DSM-5) at screening visit, confirmed by Structured Interview for DSM-5 Personality Disorder (SCID-5-PD). Zanarini rating scale for Borderline personality disorder (ZAN-BPD) of ≥ 9 at screening (Visit 1) and randomization (Visit 2), with question #2 Affective Instability score of ≥2. Male or female patients, 18-65 years of age at the time of consent Women of childbearing potential (WOCBP) able and willing to use two methods of contraception, as confirmed by the investigator, which include one highly effective method of birth control per ICH M3 (R2) that results in a low failure rate of less than 1%, plus one barrier method. --A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming postmenopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Tubal occlusion/ ligation is NOT a method of permanent sterilization. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Signed and dated written informed consent in accordance with International Council on Harmonization (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial. further inclusion criteria apply. Exclusion Criteria: Current diagnosis of paranoid, schizoid, schizotypal and antisocial personality disorders, as confirmed by SCID-5-PD at screening visit. Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, bipolar I disorder, or delusional disorder as confirmed by the SCID-5 at the screening visit. Any other mental disorder that is the primary focus of treatment in the last 6 months prior to randomization, as per the clinical judgement of the investigator. Inpatient stay or hospitalization due to worsening of BoPD within 3 months prior to randomization. Initiation or change in any type or frequency of psychotherapy for BoPD within the last 3 months prior to screening. Any ongoing use of psychotropic medications within 7 days prior to randomization or during the course of study. Any suicidal behavior in the past 1 year. Any suicidal ideation of type 4 or 5 in the Columbia Suicidal Severity Rating Scale (C-SSRS) in the past 3 months. further exclusion criteria apply.
Facility Information:
Facility Name
Advanced Research Center, Inc.
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Viking Clinical Research, Ltd.
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Pacific Clinical Research Management Group LLC
City
Upland
State/Province
California
ZIP/Postal Code
91786
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Facility Name
Gulf Coast Clinical Research Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Facility Name
Sarkis Clinical Trials
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32607
Country
United States
Facility Name
San Marcus Research Clinic, Inc.
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Institute for Advanced Medical Research
City
Alpharetta
State/Province
Georgia
ZIP/Postal Code
30022
Country
United States
Facility Name
McLean Hospital
City
Belmont
State/Province
Massachusetts
ZIP/Postal Code
02478
Country
United States
Facility Name
Precise Research Centers
City
Flowood
State/Province
Mississippi
ZIP/Postal Code
39232
Country
United States
Facility Name
Center For Emotional Fitness
City
Cherry Hill
State/Province
New Jersey
ZIP/Postal Code
08002
Country
United States
Facility Name
University at Buffalo, The State University of New York
City
Buffalo
State/Province
New York
ZIP/Postal Code
14215
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Central States Research, LLC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Grayline Research Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Core Clinical Research
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
City
Caba
ZIP/Postal Code
C1133AAH
Country
Argentina
Facility Name
Fundación FunDaMos para la asistencia e investigación en psiquiatría
City
Caba
ZIP/Postal Code
C1405BOA
Country
Argentina
Facility Name
CEN (Centro Especializado Neurociencias)
City
Cordoba
ZIP/Postal Code
5004
Country
Argentina
Facility Name
Instituto Médico DAMIC S.R.L.
City
Cordoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Facility Name
Instituto Modelo de Neurología Lennox
City
Córdoba
ZIP/Postal Code
X5000FAL
Country
Argentina
Facility Name
Clinica Privada de Salud Mental Santa Teresa de Avila
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Instituto de Neurociencias San Agustín
City
La Plata
ZIP/Postal Code
1900
Country
Argentina
Facility Name
Instituto Médico de la Fundación Estudios Clínicos
City
Rosario
ZIP/Postal Code
2000
Country
Argentina
Facility Name
Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
City
Rosario
ZIP/Postal Code
S2000QJI
Country
Argentina
Facility Name
Peninsula Therapeutic and Research Group
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Monash Alfred Psychiatry Research Centre
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
City
Duffel
ZIP/Postal Code
2570
Country
Belgium
Facility Name
"Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Facility Name
University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Medical Center Intermedica Ltd.
City
Sofia
ZIP/Postal Code
1680
Country
Bulgaria
Facility Name
MPMeditrine s.r.o.
City
Ostrava-Poruba
ZIP/Postal Code
708 68
Country
Czechia
Facility Name
Clintrial s.r.o.
City
Prague
ZIP/Postal Code
10000
Country
Czechia
Facility Name
INEP medical s.r.o.
City
Prague
ZIP/Postal Code
18600
Country
Czechia
Facility Name
Aalborg Universitetsshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Region Zealand, Psychiatric Research Unit
City
Slagelse
ZIP/Postal Code
4600
Country
Denmark
Facility Name
HOP Pierre Wertheimer
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
HOP la Colombière
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Universitätsklinikum Aachen, AöR
City
Aachen
ZIP/Postal Code
52074
Country
Germany
Facility Name
Charité - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Universitätsklinikum Bonn AöR
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Gießen
ZIP/Postal Code
35385
Country
Germany
Facility Name
Zentralinstitut für seelische Gesundheit
City
Mannheim
ZIP/Postal Code
68159
Country
Germany
Facility Name
Klinikum der Universität München - Campus Innenstadt
City
München
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitätsklinikum Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
IRCCS San Giovanni Di Dio Fatebenefratelli
City
Brescia
ZIP/Postal Code
25125
Country
Italy
Facility Name
Kokoro no Clinic Hirao
City
Fukuoka, Fukuoka
ZIP/Postal Code
815-0071
Country
Japan
Facility Name
Hirota Clinic
City
Fukuoka, Kurume
ZIP/Postal Code
830-0033
Country
Japan
Facility Name
Kishiro Mental Clinic
City
Kanagawa, Kawasaki
ZIP/Postal Code
214-0014
Country
Japan
Facility Name
Hiyoshi Hospital
City
Kanagawa, Yokohama
ZIP/Postal Code
223-0062
Country
Japan
Facility Name
Nara Medical University Hospital
City
Nara, Kashihara
ZIP/Postal Code
634-8522
Country
Japan
Facility Name
i Kokoro Clinic Nihonbashi
City
Tokyo, Chuo-ku
ZIP/Postal Code
103-0012
Country
Japan
Facility Name
Ichigaya Himorogi Clinic
City
Tokyo, Shinjuku-ku
ZIP/Postal Code
162-0843
Country
Japan
Facility Name
GabiPros S.C.
City
Cdmx
ZIP/Postal Code
07000
Country
Mexico
Facility Name
Medical Care & Research SA de CV
City
Merida
ZIP/Postal Code
97070
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
CIT-Neuropsique S.C
City
Monterrey
ZIP/Postal Code
64610
Country
Mexico
Facility Name
Centro de Estudios Clinicos de Queretaro S.C
City
Queretaro
ZIP/Postal Code
76000
Country
Mexico
Facility Name
BIND Investigaciones S.C.
City
San Luis Potosi
ZIP/Postal Code
78213
Country
Mexico
Facility Name
Podlassian Center of Psychogeriatry, Bialystok
City
Bialystok
ZIP/Postal Code
15-732
Country
Poland
Facility Name
PI HOUSE Sp. z o.o., Gdansk
City
Gdansk
ZIP/Postal Code
80-546
Country
Poland
Facility Name
Hospital Universitario Marqués de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
CS Casa del Barco
City
Valladolid
ZIP/Postal Code
47007
Country
Spain
Facility Name
Psykiatri Södra Stockholm
City
Enskede
ZIP/Postal Code
122 31
Country
Sweden
Facility Name
Sahlgrenska Universitetssjukhuset, Östra
City
Göteborg
ZIP/Postal Code
416 50
Country
Sweden
Facility Name
Akademiska sjukhuset
City
Uppsala
ZIP/Postal Code
751 85
Country
Sweden

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
Citations:
PubMed Identifier
36375174
Citation
Stoffers-Winterling JM, Storebo OJ, Pereira Ribeiro J, Kongerslev MT, Vollm BA, Mattivi JT, Faltinsen E, Todorovac A, Jorgensen MS, Callesen HE, Sales CP, Schaug JP, Simonsen E, Lieb K. Pharmacological interventions for people with borderline personality disorder. Cochrane Database Syst Rev. 2022 Nov 14;11(11):CD012956. doi: 10.1002/14651858.CD012956.pub2.
Results Reference
derived
Links:
URL
https://www.mystudywindow.com/
Description
Related Info

Learn more about this trial

A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder

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