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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04566601
Registration number
NCT04566601
Ethics application status
Date submitted
23/09/2020
Date registered
28/09/2020
Date last updated
30/01/2024
Titles & IDs
Public title
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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Scientific 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
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Secondary ID [1]
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2020-000078-12
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Secondary ID [2]
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1402-0012
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Borderline Personality Disorder
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Condition category
Condition code
Mental Health
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Psychosis and personality disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - BI 1358894
Treatment: Drugs - Placebo
Experimental: BI 1358894 5mg -
Experimental: BI 1358894 25mg -
Experimental: BI 1358894 75mg -
Experimental: BI 1358894 125mg -
Placebo Comparator: Placebo -
Treatment: Drugs: BI 1358894
Film-coated tablet
Treatment: Drugs: Placebo
Film-coated tablet
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10
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Assessment method [1]
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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.
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Timepoint [1]
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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.
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Secondary outcome [1]
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ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as =30% ZAN-BPD Reduction From Baseline at Week 10
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Assessment method [1]
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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.
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Timepoint [1]
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Baseline and at Week 10.
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Secondary outcome [2]
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Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10
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Assessment method [2]
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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.
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Timepoint [2]
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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.
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Secondary outcome [3]
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Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10
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Assessment method [3]
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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.
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Timepoint [3]
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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.
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Secondary outcome [4]
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Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10
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Assessment method [4]
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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.
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Timepoint [4]
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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.
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Secondary outcome [5]
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Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10
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Assessment method [5]
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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.
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Timepoint [5]
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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.
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Secondary outcome [6]
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Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10
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Assessment method [6]
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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.
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Timepoint [6]
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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.
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Eligibility
Key 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.
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Minimum age
18
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Maximum age
65
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/11/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/01/2023
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Sample size
Target
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Accrual to date
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Final
390
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Peninsula Therapeutic and Research Group - Frankston
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Recruitment hospital [2]
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Monash Alfred Psychiatry Research Centre - Melbourne
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Recruitment postcode(s) [1]
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3199 - Frankston
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Recruitment postcode(s) [2]
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3004 - Melbourne
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Recruitment outside Australia
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United States of America
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California
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United States of America
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Connecticut
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United States of America
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Florida
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Georgia
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Massachusetts
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Mississippi
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New Jersey
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New York
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Oklahoma
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Texas
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Washington
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Argentina
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Caba
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Argentina
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Cordoba
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Argentina
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Córdoba
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Argentina
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La Plata
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Argentina
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Rosario
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Belgium
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Duffel
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Czechia
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Ostrava-Poruba
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Czechia
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Prague
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Denmark
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Aalborg
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Denmark
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Slagelse
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Bron
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France
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Montpellier
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Germany
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Aachen
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Germany
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Berlin
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Germany
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Bonn
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Germany
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Gießen
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Germany
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Mannheim
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Germany
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München
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Germany
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Tübingen
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Italy
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Brescia
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Japan
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Fukuoka, Fukuoka
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Japan
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Fukuoka, Kurume
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Kanagawa, Kawasaki
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Japan
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Kanagawa, Yokohama
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Nara, Kashihara
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Tokyo, Chuo-ku
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Japan
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Tokyo, Shinjuku-ku
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Mexico
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Cdmx
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Mexico
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Merida
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Mexico
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Monterrey
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Mexico
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Queretaro
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Mexico
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San Luis Potosi
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Poland
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Bialystok
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Poland
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Gdansk
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Spain
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Santander
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Spain
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Sevilla
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Spain
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Valladolid
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Sweden
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Enskede
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Sweden
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Göteborg
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Sweden
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Uppsala
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04566601
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04566601
Download to PDF