A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder
NCT ID: NCT04566601
Last Updated: 2024-01-30
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
390 participants
INTERVENTIONAL
2020-11-13
2023-01-25
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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BI 1358894 5mg
BI 1358894
Film-coated tablet
BI 1358894 25mg
BI 1358894
Film-coated tablet
BI 1358894 75mg
BI 1358894
Film-coated tablet
BI 1358894 125mg
BI 1358894
Film-coated tablet
Placebo
Placebo
Film-coated tablet
Interventions
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BI 1358894
Film-coated tablet
Placebo
Film-coated tablet
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Locations
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Advanced Research Center, Inc.
Anaheim, California, United States
Viking Clinical Research, Ltd.
Temecula, California, United States
Pacific Clinical Research Management Group LLC
Upland, California, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Gulf Coast Clinical Research Center
Fort Myers, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
San Marcus Research Clinic, Inc.
Miami, Florida, United States
Institute for Advanced Medical Research
Alpharetta, Georgia, United States
McLean Hospital
Belmont, Massachusetts, United States
Precise Research Centers
Flowood, Mississippi, United States
Center For Emotional Fitness
Cherry Hill, New Jersey, United States
University at Buffalo, The State University of New York
Buffalo, New York, United States
Neurobehavioral Research, Inc.
Cedarhurst, New York, United States
Central States Research, LLC
Tulsa, Oklahoma, United States
Grayline Research Center
Wichita Falls, Texas, United States
Core Clinical Research
Everett, Washington, United States
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
CABA, , Argentina
Fundación FunDaMos para la asistencia e investigación en psiquiatría
CABA, , Argentina
CEN (Centro Especializado Neurociencias)
Córdoba, , Argentina
Instituto Modelo de Neurología Lennox
Córdoba, , Argentina
Instituto Médico DAMIC S.R.L.
Córdoba, , Argentina
Clinica Privada de Salud Mental Santa Teresa de Avila
La Plata, , Argentina
Instituto de Neurociencias San Agustín
La Plata, , Argentina
Instituto Médico de la Fundación Estudios Clínicos
Rosario, , Argentina
Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
Rosario, , Argentina
Peninsula Therapeutic and Research Group
Frankston, Victoria, Australia
Monash Alfred Psychiatry Research Centre
Melbourne, Victoria, Australia
Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
Duffel, , Belgium
"Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry
Plovdiv, , Bulgaria
University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD
Sofia, , Bulgaria
Medical Center Intermedica Ltd.
Sofia, , Bulgaria
MPMeditrine s.r.o.
Ostrava-Poruba, , Czechia
Clintrial s.r.o.
Prague, , Czechia
INEP medical s.r.o.
Prague, , Czechia
Aalborg Universitetsshospital
Aalborg, , Denmark
Region Zealand, Psychiatric Research Unit
Slagelse, , Denmark
HOP Pierre Wertheimer
Bron, , France
HOP la Colombière
Montpellier, , France
Universitätsklinikum Aachen, AöR
Aachen, , Germany
Charité - Universitätsmedizin Berlin
Berlin, , Germany
Universitätsklinikum Bonn AöR
Bonn, , Germany
Universitätsklinikum Gießen und Marburg GmbH
Giessen, , Germany
Zentralinstitut für seelische Gesundheit
Mannheim, , Germany
Klinikum der Universität München - Campus Innenstadt
München, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
IRCCS San Giovanni Di Dio Fatebenefratelli
Brescia, , Italy
Kokoro no Clinic Hirao
Fukuoka, Fukuoka, , Japan
Hirota Clinic
Fukuoka, Kurume, , Japan
Kishiro Mental Clinic
Kanagawa, Kawasaki, , Japan
Hiyoshi Hospital
Kanagawa, Yokohama, , Japan
Nara Medical University Hospital
Nara, Kashihara, , Japan
i Kokoro Clinic Nihonbashi
Tokyo, Chuo-ku, , Japan
Ichigaya Himorogi Clinic
Tokyo, Shinjuku-ku, , Japan
GabiPros S.C.
Mexico City, , Mexico
Medical Care & Research SA de CV
Mérida, , Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, , Mexico
CIT-Neuropsique S.C
Monterrey, , Mexico
Centro de Estudios Clinicos de Queretaro S.C
Querétaro, , Mexico
BIND Investigaciones S.C.
San Luis Potosí City, , Mexico
Podlassian Center of Psychogeriatry, Bialystok
Bialystok, , Poland
PI HOUSE Sp. z o.o., Gdansk
Gdansk, , Poland
Hospital Universitario Marqués de Valdecilla
Santander, , Spain
Hospital Virgen del Rocío
Seville, , Spain
CS Casa del Barco
Valladolid, , Spain
Psykiatri Södra Stockholm
Enskede, , Sweden
Sahlgrenska Universitetssjukhuset, Östra
Gothenburg, , Sweden
Akademiska sjukhuset
Uppsala, , Sweden
Countries
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References
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Dwyer JB, Schmahl C, Makinodan M, Fineberg SK, Sommer S, Wruck J, Jelaska A, Adeniji A, Goodman M. Efficacy and Safety of BI 1358894 in Patients With Borderline Personality Disorder: Results of a Phase 2 Randomized, Placebo-Controlled, Parallel Group Dose-Ranging Trial. J Clin Psychiatry. 2025 Jan 13;86(1):24m15523. doi: 10.4088/JCP.24m15523.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2020-000078-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1402-0012
Identifier Type: -
Identifier Source: org_study_id
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