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

NCT04566601 | Completed Phase 2 Results DMC FDA Drug

• 2 other identifiers: 1402-00122020-000078-12
• Study Type: interventional
• Target: 390
• Locations: 15 countries
• Sites: 67

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.

Conditions

Borderline Personality Disorder

Outcome Measures

Primary Outcomes (1)

• 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 DSM-5 criteria and the scale has 4 domain scores that reflect core areas of BPD (i.e., affective, cognitive, impulsive and interpersonal symptoms). The ZAN-BPD scale includes a 5-point rating scale (i.e., 0 = no symptoms to 4 = severe symptoms) for each criterion. The total ZAN-BPD score is the sum of the 4 domain scores and ranges from 0 to 36 where higher scores mean severe symptoms. Least Squares (LS) mean and standard error were estimated by restricted maximum likelihood-based mixed effects model repeated measures (REML-based MMRM) including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8 and 10) and the baseline ZAN-BPD total score strata indicator (\<=18 vs. \>=19), the continuous fixed covariate of baseline ZAN-BPD total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. LS mean (standard error) for Week 10 are reported.

  The change from baseline at Week 10 in the total ZAN-BPD score was calculated using the MMRM model which is a longitudinal analyses and it incorporates ZAN-BPD measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.

Secondary Outcomes (6)

• ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as ≥30% ZAN-BPD Reduction From Baseline at Week 10

  Baseline and at Week 10.

• Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10

  Change from baseline in DERS-16 total score at Week 10 was calculated using the MMRM model which is a longitudinal analyses and it incorporates DERS-16 measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.

• Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10

  Change from baseline in STAI-S total score at Week 10 was calculated using the MMRM model which is a longitudinal analyses and it incorporates STAI-S measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.

• Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10

  Change from baseline in PHQ-9 total score at Week 10 was calculated using the MMRM model which is a longitudinal analyses and it incorporates PHQ-9 measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.

• Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10

  Change from baseline in CGI-S scale at Week 10 was calculated using the MMRM model which is a longitudinal analyses and it incorporates CGI-S measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10.

Study Arms (5)

BI 1358894 5mg

EXPERIMENTAL

Drug: BI 1358894

BI 1358894 25mg

EXPERIMENTAL

Drug: BI 1358894

BI 1358894 75mg

EXPERIMENTAL

Drug: BI 1358894

BI 1358894 125mg

EXPERIMENTAL

Drug: BI 1358894

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

BI 1358894 DRUG

Film-coated tablet

BI 1358894 125mg; BI 1358894 25mg; BI 1358894 5mg; BI 1358894 75mg

Placebo DRUG

Film-coated tablet

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (67)

Advanced Research Center, Inc.

Anaheim, California, 92805, United States

Location

Viking Clinical Research, Ltd.

Temecula, California, 92591, United States

Location

Pacific Clinical Research Management Group LLC

Upland, California, 91786, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06519, United States

Location

Gulf Coast Clinical Research Center

Fort Myers, Florida, 33912, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

San Marcus Research Clinic, Inc.

Miami, Florida, 33014, United States

Location

Institute for Advanced Medical Research

Alpharetta, Georgia, 30022, United States

Location

McLean Hospital

Belmont, Massachusetts, 02478, United States

Location

Precise Research Centers

Flowood, Mississippi, 39232, United States

Location

Center For Emotional Fitness

Cherry Hill, New Jersey, 08002, United States

Location

University at Buffalo, The State University of New York

Buffalo, New York, 14215, United States

Location

Neurobehavioral Research, Inc.

Cedarhurst, New York, 11516, United States

Location

Central States Research, LLC

Tulsa, Oklahoma, 74136, United States

Location

Grayline Research Center

Wichita Falls, Texas, 76309, United States

Location

Core Clinical Research

Everett, Washington, 98201, United States

Location

Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)

CABA, C1133AAH, Argentina

Location

Fundación FunDaMos para la asistencia e investigación en psiquiatría

CABA, C1405BOA, Argentina

Location

CEN (Centro Especializado Neurociencias)

Córdoba, 5004, Argentina

Location

Instituto Modelo de Neurología Lennox

Córdoba, X5000FAL, Argentina

Location

Instituto Médico DAMIC S.R.L.

Córdoba, X5003DCE, Argentina

Location

Clinica Privada de Salud Mental Santa Teresa de Avila

La Plata, 1900, Argentina

Location

Instituto de Neurociencias San Agustín

La Plata, 1900, Argentina

Location

Instituto Médico de la Fundación Estudios Clínicos

Rosario, 2000, Argentina

Location

Centro de Investigacion y Asistencia en Psiquiatria (CIAP)

Rosario, S2000QJI, Argentina

Location

Peninsula Therapeutic and Research Group

Frankston, Victoria, 3199, Australia

Location

Monash Alfred Psychiatry Research Centre

Melbourne, Victoria, 3004, Australia

Location

Universitair Psychiatrisch Centrum Duffel (UPC Duffel)

Duffel, 2570, Belgium

Location

"Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry

Plovdiv, 4000, Bulgaria

Location

University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD

Sofia, 1431, Bulgaria

Location

Medical Center Intermedica Ltd.

Sofia, 1680, Bulgaria

Location

MPMeditrine s.r.o.

Ostrava-Poruba, 708 68, Czechia

Location

Clintrial s.r.o.

Prague, 10000, Czechia

Location

INEP medical s.r.o.

Prague, 18600, Czechia

Location

Aalborg Universitetsshospital

Aalborg, 9000, Denmark

Location

Region Zealand, Psychiatric Research Unit

Slagelse, 4600, Denmark

Location

HOP Pierre Wertheimer

Bron, 69677, France

Location

HOP la Colombière

Montpellier, 34295, France

Location

Universitätsklinikum Aachen, AöR

Aachen, 52074, Germany

Location

Charité - Universitätsmedizin Berlin

Berlin, 12203, Germany

Location

Universitätsklinikum Bonn AöR

Bonn, 53127, Germany

Location

Universitätsklinikum Gießen und Marburg GmbH

Giessen, 35385, Germany

Location

Zentralinstitut für seelische Gesundheit

Mannheim, 68159, Germany

Location

Klinikum der Universität München - Campus Innenstadt

München, 80336, Germany

Location

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

Location

IRCCS San Giovanni Di Dio Fatebenefratelli

Brescia, 25125, Italy

Location

Kokoro no Clinic Hirao

Fukuoka, Fukuoka, 815-0071, Japan

Location

Hirota Clinic

Fukuoka, Kurume, 830-0033, Japan

Location

Kishiro Mental Clinic

Kanagawa, Kawasaki, 214-0014, Japan

Location

Hiyoshi Hospital

Kanagawa, Yokohama, 223-0062, Japan

Location

Nara Medical University Hospital

Nara, Kashihara, 634-8522, Japan

Location

i Kokoro Clinic Nihonbashi

Tokyo, Chuo-ku, 103-0012, Japan

Location

Ichigaya Himorogi Clinic

Tokyo, Shinjuku-ku, 162-0843, Japan

Location

GabiPros S.C.

Mexico City, 07000, Mexico

Location

Medical Care & Research SA de CV

Mérida, 97070, Mexico

Location

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, 64460, Mexico

Location

CIT-Neuropsique S.C

Monterrey, 64610, Mexico

Location

Centro de Estudios Clinicos de Queretaro S.C

Querétaro, 76000, Mexico

Location

BIND Investigaciones S.C.

San Luis Potosí City, 78213, Mexico

Location

Podlassian Center of Psychogeriatry, Bialystok

Bialystok, 15-732, Poland

Location

PI HOUSE Sp. z o.o., Gdansk

Gdansk, 80-546, Poland

Location

Hospital Universitario Marqués de Valdecilla

Santander, 39008, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

CS Casa del Barco

Valladolid, 47007, Spain

Location

Psykiatri Södra Stockholm

Enskede, 122 31, Sweden

Location

Sahlgrenska Universitetssjukhuset, Östra

Gothenburg, 416 50, Sweden

Location

Akademiska sjukhuset

Uppsala, 751 85, Sweden

Location

Related Publications (2)

• 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.

  PMID: 39832346 DERIVED

• 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.

  PMID: 36375174 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

TRPC inhibitor BI 1358894

Condition Hierarchy (Ancestors)

Personality Disorders; Mental Disorders

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: September 28, 2020
• Study Start: November 13, 2020
• Primary Completion: December 9, 2022
• Study Completion: January 25, 2023
• Last Updated: January 30, 2024
• Results First Posted: January 30, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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'.

Locations

BU (3); SE (3); CZ (3); FR (2); IT (1); ES (3); PL (2); DK (2); AR (9); US (16); AU (2); BE (1); ME (6); DE (7); JP (7)