A Study to Test Different Doses of BI 1358894 and Find Out Whether They Reduce Symptoms in People With Borderline Personality Disorder
- Conditions
- Borderline Personality Disorder
- Interventions
- Drug: PlaceboDrug: BI 1358894
- Registration Number
- NCT04566601
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 390
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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).
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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.
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Male or female patients, 18-65 years of age at the time of consent
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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.
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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.
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further inclusion criteria apply.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo - BI 1358894 25mg BI 1358894 - BI 1358894 125mg BI 1358894 - BI 1358894 75mg BI 1358894 - BI 1358894 5mg BI 1358894 -
- Primary Outcome Measures
Name Time Method Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 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. 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.
- Secondary Outcome Measures
Name Time Method 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. The STAI-S consists of 20 item state anxiety questions that evaluate how respondents feel "right now, at this moment". All items are rated on a weighted score of 1 to 4 scale (e.g. from 'Almost Never to 'Almost Always'); with higher scores indicating greater anxiety. STAI-S score ranges from 20 to 80 where higher scores indicate greater anxiety.
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, 10) and the continuous fixed covariate of baseline STAI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.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. The DERS is a self-report measure of emotion regulation difficulties. It consists of 16 items that assess non-acceptance of negative emotions, inability to engage in goal-directed behaviors when distressed, difficulties controlling impulsive behaviors when distressed, limited access to emotion regulation strategies perceived as effective, and lack of emotional clarity. Each item is scored from 1 (almost never (0-10%)) to 5 (almost always (91-100%)). Total DERS-16 can range from 16 to 80, with higher scores reflecting greater levels of emotion dysregulation.
Least Squares (LS) mean and standard error were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8 and 10) and the continuous fixed covariate of baseline DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.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. Number of participants with ZAN-BPD response is reported. ZAN-BPD response was defined as ≥30% ZAN-BPD reduction from baseline 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.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. The PHQ-9 is a 9-item brief self-reported tool used for screening, diagnosing, monitoring and measuring the severity of depression. PHQ-9 has a maximum total score of 27. Depression Severity is assessed as: none (0-4), mild (5-9), moderate (10-14), moderately severe (15-19), or severe (20-27).
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, 10) and the continuous fixed covariate of baseline PHQ-9 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.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. The CGI-S rating scale measures the clinician's impression of the severity of illness exhibited by a participant. The CGI-S only question states "Considering your total clinical experience with this particular population, please choose the response below that best describes how mentally ill the patient was over the past week?", and is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
Least Squares (LS) mean and standard error were estimated by REML-based MMRM including the fixed categorical covariates of treatment, visit (baseline and Week 1, 2, 4, 6, 8, 10) and the continuous fixed covariate of baseline CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS mean (standard error) for Week 10 are reported.Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10 Change from baseline in PGI-S scale at Week 10 was calculated using the MMRM model which is a longitudinal analyses and it incorporates PGI-S measurements from baseline, Weeks 1, 2, 4, 6, 8 and Week 10. The PGI-S measures the patient's impression of the severity of their illness. It is a single item 5-point scale that asks patients to rate the severity of their illness. The PGI-S question states "Please choose the response below that best describes the overall severity of your symptoms of Borderline Personality Disorder at this time. (Select one response)": 1=No symptoms; 2=Mild; 3=Moderate; 4=Severe; 5=Very severe.
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, 8,10) and the continuous fixed covariate of baseline PGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. LS means (standard error) for Week 10 are reported.
Trial Locations
- Locations (67)
McLean Hospital
🇺🇸Belmont, Massachusetts, United States
Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
🇦🇷Caba, Argentina
Instituto Médico DAMIC S.R.L.
🇦🇷Cordoba, Argentina
Fundación FunDaMos para la asistencia e investigación en psiquiatría
🇦🇷Caba, Argentina
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
CEN (Centro Especializado Neurociencias)
🇦🇷Cordoba, Argentina
Clinica Privada de Salud Mental Santa Teresa de Avila
🇦🇷La Plata, Argentina
Instituto Modelo de Neurología Lennox
🇦🇷Córdoba, Argentina
INEP medical s.r.o.
🇨🇿Prague, Czechia
Region Zealand, Psychiatric Research Unit
🇩🇰Slagelse, Denmark
IRCCS San Giovanni Di Dio Fatebenefratelli
🇮🇹Brescia, Italy
Viking Clinical Research, Ltd.
🇺🇸Temecula, California, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Gulf Coast Clinical Research Center
🇺🇸Fort Myers, Florida, United States
Pacific Clinical Research Management Group LLC
🇺🇸Upland, California, United States
Precise Research Centers
🇺🇸Flowood, Mississippi, United States
Institute for Advanced Medical Research
🇺🇸Alpharetta, Georgia, United States
Center For Emotional Fitness
🇺🇸Cherry Hill, New Jersey, United States
Neurobehavioral Research, Inc.
🇺🇸Cedarhurst, New York, United States
University at Buffalo, The State University of New York
🇺🇸Buffalo, 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
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
Aalborg Universitetsshospital
🇩🇰Aalborg, Denmark
Clintrial s.r.o.
🇨🇿Prague, Czechia
MPMeditrine s.r.o.
🇨🇿Ostrava-Poruba, Czechia
HOP Pierre Wertheimer
🇫🇷Bron, France
HOP la Colombière
🇫🇷Montpellier, France
Universitätsklinikum Bonn AöR
🇩🇪Bonn, Germany
Kishiro Mental Clinic
🇯🇵Kanagawa, Kawasaki, Japan
Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Gießen, Germany
Universitätsklinikum Aachen, AöR
🇩🇪Aachen, Germany
Klinikum der Universität München - Campus Innenstadt
🇩🇪München, Germany
Charité - Universitätsmedizin Berlin
🇩🇪Berlin, Germany
Universitätsklinikum Tübingen
🇩🇪Tübingen, Germany
Zentralinstitut für seelische Gesundheit
🇩🇪Mannheim, Germany
Kokoro no Clinic Hirao
🇯🇵Fukuoka, Fukuoka, Japan
Hirota Clinic
🇯🇵Fukuoka, Kurume, 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.
🇲🇽Cdmx, Mexico
Medical Care & Research SA de CV
🇲🇽Merida, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
🇲🇽Monterrey, Mexico
CIT-Neuropsique S.C
🇲🇽Monterrey, Mexico
Centro de Estudios Clinicos de Queretaro S.C
🇲🇽Queretaro, Mexico
Podlassian Center of Psychogeriatry, Bialystok
🇵🇱Bialystok, Poland
BIND Investigaciones S.C.
🇲🇽San Luis Potosi, Mexico
PI HOUSE Sp. z o.o., Gdansk
🇵🇱Gdansk, Poland
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
CS Casa del Barco
🇪🇸Valladolid, Spain
Psykiatri Södra Stockholm
🇸🇪Enskede, Sweden
Sahlgrenska Universitetssjukhuset, Östra
🇸🇪Göteborg, Sweden
Akademiska sjukhuset
🇸🇪Uppsala, Sweden
San Marcus Research Clinic, Inc.
🇺🇸Miami, Florida, United States