Clinical trial NCT04566601: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Borderline Personality Disorder
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2020-09-28
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10
timeFrame: 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:
measure: ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as ≥30% ZAN-BPD Reduction From Baseline at Week 10
timeFrame: Baseline and at Week 10.
measure: Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10
timeFrame: 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.
measure: Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10
timeFrame: 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.
measure: Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10
timeFrame: 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.
measure: Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10
timeFrame: 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.
measure: Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10
timeFrame: 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.
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Research Center, Inc.
state: California
city: Temecula
country: United States
facility: Viking Clinical Research, Ltd.
state: California
city: Upland
country: United States
facility: Pacific Clinical Research Management Group LLC
state: California
city: New Haven
country: United States
facility: Yale University School of Medicine
state: Connecticut
city: Fort Myers
country: United States
facility: Gulf Coast Clinical Research Center
state: Florida
city: Gainesville
country: United States
facility: Sarkis Clinical Trials
state: Florida
city: Miami
country: United States
facility: San Marcus Research Clinic, Inc.
state: Florida
city: Alpharetta
country: United States
facility: Institute for Advanced Medical Research
state: Georgia
city: Belmont
country: United States
facility: McLean Hospital
state: Massachusetts
city: Flowood
country: United States
facility: Precise Research Centers
state: Mississippi
city: Cherry Hill
country: United States
facility: Center For Emotional Fitness
state: New Jersey
city: Buffalo
country: United States
facility: University at Buffalo, The State University of New York
state: New York
city: Cedarhurst
country: United States
facility: Neurobehavioral Research, Inc.
state: New York
city: Tulsa
country: United States
facility: Central States Research, LLC
state: Oklahoma
city: Wichita Falls
country: United States
facility: Grayline Research Center
state: Texas
city: Everett
country: United States
facility: Core Clinical Research
state: Washington
city: Caba
country: Argentina
facility: Fundación para el Estudio y Tratamiento de las Enfermedades Mentales (FETEM)
city: Caba
country: Argentina
facility: Fundación FunDaMos para la asistencia e investigación en psiquiatría
city: Cordoba
country: Argentina
facility: CEN (Centro Especializado Neurociencias)
city: Cordoba
country: Argentina
facility: Instituto Médico DAMIC S.R.L.
city: Córdoba
country: Argentina
facility: Instituto Modelo de Neurología Lennox
city: La Plata
country: Argentina
facility: Clinica Privada de Salud Mental Santa Teresa de Avila
city: La Plata
country: Argentina
facility: Instituto de Neurociencias San Agustín
city: Rosario
country: Argentina
facility: Instituto Médico de la Fundación Estudios Clínicos
city: Rosario
country: Argentina
facility: Centro de Investigacion y Asistencia en Psiquiatria (CIAP)
city: Frankston
country: Australia
facility: Peninsula Therapeutic and Research Group
state: Victoria
city: Melbourne
country: Australia
facility: Monash Alfred Psychiatry Research Centre
state: Victoria
city: Duffel
country: Belgium
facility: Universitair Psychiatrisch Centrum Duffel (UPC Duffel)
city: Plovdiv
country: Bulgaria
facility: "Filipopolis" - Ambulatory for Group Practice for Specialized Care in Psychiatry
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD
city: Sofia
country: Bulgaria
facility: Medical Center Intermedica Ltd.
city: Ostrava-Poruba
country: Czechia
facility: MPMeditrine s.r.o.
city: Prague
country: Czechia
facility: Clintrial s.r.o.
city: Prague
country: Czechia
facility: INEP medical s.r.o.
city: Aalborg
country: Denmark
facility: Aalborg Universitetsshospital
city: Slagelse
country: Denmark
facility: Region Zealand, Psychiatric Research Unit
city: Bron
country: France
facility: HOP Pierre Wertheimer
city: Montpellier
country: France
facility: HOP la Colombière
city: Aachen
country: Germany
facility: Universitätsklinikum Aachen, AöR
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AöR
city: Gießen
country: Germany
facility: Universitätsklinikum Gießen und Marburg GmbH
city: Mannheim
country: Germany
facility: Zentralinstitut für seelische Gesundheit
city: München
country: Germany
facility: Klinikum der Universität München - Campus Innenstadt
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Brescia
country: Italy
facility: IRCCS San Giovanni Di Dio Fatebenefratelli
city: Fukuoka, Fukuoka
country: Japan
facility: Kokoro no Clinic Hirao
city: Fukuoka, Kurume
country: Japan
facility: Hirota Clinic
city: Kanagawa, Kawasaki
country: Japan
facility: Kishiro Mental Clinic
city: Kanagawa, Yokohama
country: Japan
facility: Hiyoshi Hospital
city: Nara, Kashihara
country: Japan
facility: Nara Medical University Hospital
city: Tokyo, Chuo-ku
country: Japan
facility: i Kokoro Clinic Nihonbashi
city: Tokyo, Shinjuku-ku
country: Japan
facility: Ichigaya Himorogi Clinic
city: Cdmx
country: Mexico
facility: GabiPros S.C.
city: Merida
country: Mexico
facility: Medical Care & Research SA de CV
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Monterrey
country: Mexico
facility: CIT-Neuropsique S.C
city: Queretaro
country: Mexico
facility: Centro de Estudios Clinicos de Queretaro S.C
city: San Luis Potosi
country: Mexico
facility: BIND Investigaciones S.C.
city: Bialystok
country: Poland
facility: Podlassian Center of Psychogeriatry, Bialystok
city: Gdansk
country: Poland
facility: PI HOUSE Sp. z o.o., Gdansk
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Valladolid
country: Spain
facility: CS Casa del Barco
city: Enskede
country: Sweden
facility: Psykiatri Södra Stockholm
city: Göteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Östra
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
Study officials:
References:
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.