Borderline Personality Disorder
Conditions
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.
Interventions
DRUGBI 1358894
Film-coated tablet
DRUGPlacebo
Film-coated tablet
Sponsors
Boehringer Ingelheim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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 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. |
| 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. |
Countries
Argentina, Australia, Belgium, Bulgaria, Czechia, Denmark, France, Germany, Italy, Japan, Mexico, Poland, Spain, Sweden, United States
Participant flow
Recruitment details
This was a Phase II, 12-week multicenter, multinational, randomised, double-blind, placebo-controlled, parallel-group trial in patients with borderline personality disorder (BPD). Eligible patients with BPD were randomised to receive either BI 1358894 or placebo in a 2.5:1:1:1:2 ratio (placebo or BI 1358894 5 milligram (mg), 25 mg, 75 mg, or 125 mg), for 12 weeks. This trial included a screening period, a 12-week randomised treatment period, and a 4-week follow-up period.
Pre-assignment details
All subjects were screened for eligibility prior to participation in the trial. Subjects attended a specialist site which ensured that they (the subjects) strictly met all inclusion and none of the exclusion criteria. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated.
Participants by arm
| Arm | Count |
|---|---|
| Placebo Patients were also administered for 12 weeks once daily, orally one film-coated tablet of placebo matching BI 1358894 5 milligram (mg), one film-coated tablet of placebo matching BI 1358894 25 mg and two film-coated tablets of placebo matching BI 1358894 50 mg. | 128 |
| BI 1358894 5mg Patients were administered for 12 weeks once daily, orally one film-coated tablet of 5 milligram (mg) of BI 1358894. In order to maintain blinding in regard to each treatment group since BI 1358894 tablets (5 mg, 25 mg, 50 mg) are different sizes, patients were also administered for 12 weeks once daily, orally one film-coated tablet of placebo matching BI 1358894 25 mg and two film-coated tablets of placebo matching BI 1358894 50 mg. | 52 |
| BI 1358894 25mg Patients were administered for 12 weeks once daily, orally one film-coated tablet of 25 milligram (mg) of BI 1358894. In order to maintain blinding in regard to each treatment group since BI 1358894 tablets (5 mg, 25 mg, 50 mg) are different sizes, patients were also administered for 12 weeks once daily, orally one film-coated tablet of placebo matching BI 1358894 5 mg and two film-coated tablets of placebo matching BI 1358894 50 mg. | 53 |
| BI 1358894 75mg Patients were administered for 12 weeks once daily, orally one film-coated tablet of 25 milligram (mg) of BI 1358894 and one film-coated tablet of 50 milligram (mg) of BI 1358894 (total BI 1358894 dose=75 mg). In order to maintain blinding in regard to each treatment group since BI 1358894 tablets (5 mg, 25 mg, 50 mg) are different sizes, patients were also administered for 12 weeks once daily, orally one film-coated tablet of placebo matching BI 1358894 5 mg and one film-coated tablet of placebo matching BI 1358894 50 mg. | 53 |
| BI 1358894 125mg Patients were administered for 12 weeks once daily, orally one film-coated tablet of 25 milligram (mg) of BI 1358894 and two film-coated tablets of 50 milligram (mg) of BI 1358894 (total BI 1358894 dose=125 mg). In order to maintain blinding in regard to each treatment group since BI 1358894 tablets (5 mg, 25 mg, 50 mg) are different sizes, patients were also administered for 12 weeks once daily, orally one film-coated tablet of placebo matching BI 1358894 5 mg. | 104 |
| Total | 390 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 7 | 4 | 6 | 5 | 12 |
| Overall Study | Burden of study procedures | 3 | 0 | 0 | 3 | 1 |
| Overall Study | Change of residence | 2 | 2 | 0 | 1 | 2 |
| Overall Study | No reason available | 3 | 2 | 7 | 1 | 5 |
| Overall Study | Other than listed | 13 | 4 | 2 | 1 | 4 |
| Overall Study | Perceived lack of efficacy | 2 | 0 | 1 | 1 | 2 |
| Overall Study | Protocol deviation | 3 | 0 | 1 | 1 | 1 |
| Overall Study | Technical problems | 0 | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Placebo | Total | BI 1358894 125mg | BI 1358894 75mg | BI 1358894 25mg | BI 1358894 5mg |
|---|---|---|---|---|---|---|
| Age, Continuous | 30.4 Years STANDARD_DEVIATION 9.9 | 30.2 Years STANDARD_DEVIATION 10.3 | 29.9 Years STANDARD_DEVIATION 11.2 | 30.6 Years STANDARD_DEVIATION 9.7 | 31.0 Years STANDARD_DEVIATION 11.1 | 29.2 Years STANDARD_DEVIATION 9.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants | 146 Participants | 34 Participants | 20 Participants | 25 Participants | 17 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 78 Participants | 244 Participants | 70 Participants | 33 Participants | 28 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 15 Participants | 6 Participants | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 18 Participants | 7 Participants | 4 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 19 Participants | 4 Participants | 1 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 2 Participants | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 112 Participants | 333 Participants | 85 Participants | 46 Participants | 46 Participants | 44 Participants |
| Sex: Female, Male Female | 107 Participants | 336 Participants | 83 Participants | 48 Participants | 48 Participants | 50 Participants |
| Sex: Female, Male Male | 21 Participants | 54 Participants | 21 Participants | 5 Participants | 5 Participants | 2 Participants |
| ZAN-BPD total score at Baseline | 16.6 score on a scale STANDARD_DEVIATION 5 | 16.3 score on a scale STANDARD_DEVIATION 5 | 16.4 score on a scale STANDARD_DEVIATION 5.2 | 16.1 score on a scale STANDARD_DEVIATION 4.6 | 15.8 score on a scale STANDARD_DEVIATION 4.8 | 15.7 score on a scale STANDARD_DEVIATION 5.4 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 128 | 0 / 52 | 0 / 53 | 0 / 53 | 2 / 104 |
| other Total, other adverse events | 75 / 128 | 32 / 52 | 40 / 53 | 34 / 53 | 61 / 104 |
| serious Total, serious adverse events | 11 / 128 | 4 / 52 | 3 / 53 | 4 / 53 | 16 / 104 |
Outcome results
Primary
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.
Time frame: 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.
Population: Full analysis set (FAS) consisted of all patients in TS who had a baseline and at least one evaluable post-baseline measurement for the primary endpoint. Since the MMRM included the measurements from baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10, number of participants analyzed for the primary endpoint for each arm are the participants who had a ZAN-BPD score value at baseline and one ZAN-BPD score value at one of the post-baseline timepoints up to Week 10.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 | -8.7 units on a scale | Standard Error 0.5 |
| BI 1358894 5mg | Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 | -8.0 units on a scale | Standard Error 0.9 |
| BI 1358894 25mg | Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 | -9.2 units on a scale | Standard Error 0.9 |
| BI 1358894 75mg | Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 | -8.9 units on a scale | Standard Error 0.8 |
| BI 1358894 125mg | Change From Baseline in ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Total Score at Week 10 | -9.0 units on a scale | Standard Error 0.6 |
Comparison: Least Squares (LS) mean difference and 95 % confidence interval 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 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 means differences (95 % confidence intervals) for Week 10 are reported.p-value: 0.499495% CI: [-1.31, 2.69]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95 % confidence interval 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 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 means differences (95 % confidence intervals) for Week 10 are reported.p-value: 0.601495% CI: [-2.6, 1.51]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95 % confidence interval 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 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 means differences (95 % confidence intervals) for Week 10 are reported.p-value: 0.816695% CI: [-2.17, 1.72]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95 % confidence interval 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 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 means differences (95 % confidence intervals) for Week 10 are reported.p-value: 0.658895% CI: [-1.96, 1.24]Mixed effects model repeated measures
Comparison: A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).p-value: 0.3914MCP-Mod sigmoid Emax model fit
Comparison: A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).p-value: 0.4104MCP-Mod Emax1 model fit
Comparison: A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).p-value: 0.456MCP-Mod linear model fit
Comparison: A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).p-value: 0.4908MCP-Mod exponential model fit
Comparison: A flat vs. non-flat dose-response relationship across the 4 doses of BI 1358894 and placebo was tested using the Multiple Comparison Procedure - Modelling (MCP-Mod) approach which evaluated simultaneously 5 different plausible dose-response patterns (linear, exponential, Emax 1, Emax 2 and Sigmoid Emax) while protecting the overall probability of type I error (one-sided alpha of 0.100).p-value: 0.4974MCP-Mod Emax2 model fit
Secondary
Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at 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.
Time frame: 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.
Population: Full analysis set (FAS) consisted of all patients in TS who had a baseline and at least one evaluable post-baseline measurement for the primary endpoint. Since the MMRM included the measurements from baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10, number of participants analyzed for the primary endpoint for each arm are the participants who had a CGI-S scale value at baseline and a CGI-S scale value at one of the post-baseline timepoints up to Week 10.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10 | -1.23 units on a scale | Standard Error 0.1 |
| BI 1358894 5mg | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10 | -1.29 units on a scale | Standard Error 0.2 |
| BI 1358894 25mg | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10 | -1.47 units on a scale | Standard Error 0.2 |
| BI 1358894 75mg | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10 | -1.24 units on a scale | Standard Error 0.2 |
| BI 1358894 125mg | Change From Baseline in Clinical Global Impression Severity Scale (CGI-S) at Week 10 | -1.42 units on a scale | Standard Error 0.1 |
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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 CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.p-value: 0.801695% CI: [-0.47, 0.37]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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 CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.p-value: 0.292995% CI: [-0.67, 0.2]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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 CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.p-value: 0.966695% CI: [-0.42, 0.4]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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 CGI-S total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.p-value: 0.283395% CI: [-0.52, 0.15]Mixed effects model repeated measures
Secondary
Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at 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.
Time frame: 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.
Population: Full analysis set (FAS) consisted of all patients in TS who had a baseline and at least one evaluable post-baseline measurement for the primary endpoint. Since the MMRM included the measurements from baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10, number of participants analyzed for the primary endpoint for each arm are the participants who had a DERS-16 total score value at baseline and a DERS-16 total score value at one of the post-baseline timepoints up to Week 10.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10 | -9.77 units on a scale | Standard Error 1.4 |
| BI 1358894 5mg | Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10 | -9.87 units on a scale | Standard Error 2.1 |
| BI 1358894 25mg | Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10 | -9.76 units on a scale | Standard Error 2.2 |
| BI 1358894 75mg | Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10 | -10.56 units on a scale | Standard Error 2.1 |
| BI 1358894 125mg | Change From Baseline in Difficulties in Emotion Regulation Scale (DERS-16) Total Score at Week 10 | -8.60 units on a scale | Standard Error 1.5 |
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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 DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.p-value: 0.996995% CI: [-5.08, 5.1]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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 DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.p-value: 0.967595% CI: [-5.11, 4.9]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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 DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.p-value: 0.754295% CI: [-5.73, 4.15]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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 DERS-16 total score, and treatment-by-visit interaction, as well as baseline-by-visit interaction. Patient was considered as random. Unstructured covariance matrix was used.p-value: 0.568395% CI: [-2.86, 5.19]Mixed effects model repeated measures
Secondary
Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at 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.
Time frame: 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.
Population: Full analysis set (FAS) consisted of all patients in TS who had a baseline and at least one evaluable post-baseline measurement for the primary endpoint. Since the MMRM included the measurements from baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10, number of participants analyzed for the primary endpoint for each arm are the participants who had a PGI-S scale value at baseline and a PGI-S scale value at one of the post-baseline timepoints up to Week 10.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10 | -0.61 units on a scale | Standard Error 0.1 |
| BI 1358894 5mg | Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10 | -0.73 units on a scale | Standard Error 0.1 |
| BI 1358894 25mg | Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10 | -0.73 units on a scale | Standard Error 0.2 |
| BI 1358894 75mg | Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10 | -0.64 units on a scale | Standard Error 0.1 |
| BI 1358894 125mg | Change From Baseline in Patient Global Impression Severity Scale (PGI-S) at Week 10 | -0.69 units on a scale | Standard Error 0.1 |
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.455295% CI: [-0.45, 0.2]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.473495% CI: [-0.47, 0.22]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.838895% CI: [-0.36, 0.29]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.55495% CI: [-0.35, 0.19]Mixed effects model repeated measures
Secondary
Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at 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.
Time frame: 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.
Population: Full analysis set (FAS) consisted of all patients in TS who had a baseline and at least one evaluable post-baseline measurement for the primary endpoint. Since the MMRM included the measurements from baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10, number of participants analyzed for the primary endpoint for each arm are the participants who had a PHQ-9 total score value at baseline and a PHQ-9 total score value at one of the post-baseline timepoints up to Week 10.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10 | -1.30 units on a scale | Standard Error 0.6 |
| BI 1358894 5mg | Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10 | -3.13 units on a scale | Standard Error 0.9 |
| BI 1358894 25mg | Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10 | -1.07 units on a scale | Standard Error 0.9 |
| BI 1358894 75mg | Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10 | -1.57 units on a scale | Standard Error 0.9 |
| BI 1358894 125mg | Change From Baseline in Patient Health Questionnaire (PHQ-9) Total Score at Week 10 | -1.43 units on a scale | Standard Error 0.6 |
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.078295% CI: [-3.87, 0.21]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.826695% CI: [-1.86, 2.32]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.79195% CI: [-2.28, 1.74]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.874395% CI: [-1.77, 1.51]Mixed effects model repeated measures
Secondary
Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at 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.
Time frame: 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.
Population: Full analysis set (FAS) consisted of all patients in TS who had a baseline and at least one evaluable post-baseline measurement for the primary endpoint. Since the MMRM included the measurements from baseline, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 10, number of participants analyzed for the primary endpoint for each arm are the participants who had a STAI-S total score value at baseline and a STAI-S total score value at one of the post-baseline timepoints up to Week 10.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Placebo | Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10 | -6.64 units on a scale | Standard Error 1.2 |
| BI 1358894 5mg | Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10 | -8.71 units on a scale | Standard Error 1.9 |
| BI 1358894 25mg | Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10 | -5.43 units on a scale | Standard Error 2 |
| BI 1358894 75mg | Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10 | -7.00 units on a scale | Standard Error 1.8 |
| BI 1358894 125mg | Change From Baseline in State-Trait Anxiety Inventory (STAI-S) Total Score at Week 10 | -5.49 units on a scale | Standard Error 1.3 |
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.356895% CI: [-6.49, 2.35]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.600995% CI: [-3.33, 5.75]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.870595% CI: [-4.7, 3.98]Mixed effects model repeated measures
Comparison: Least Squares (LS) mean difference and 95% confidence interval 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. Unstructured covariance matrix was used.p-value: 0.526295% CI: [-2.41, 4.71]Mixed effects model repeated measures
Secondary
ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as ≥30% ZAN-BPD Reduction From Baseline 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.
Time frame: Baseline and at Week 10.
Population: Full analysis set (FAS) consisted of all patients in TS who had a baseline and at least one evaluable post-baseline measurement for the primary endpoint.~Only participants with ZAN-BPD total score at baseline and at Week 10 are reported.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Placebo | ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as ≥30% ZAN-BPD Reduction From Baseline at Week 10 | 68 Participants |
| BI 1358894 5mg | ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as ≥30% ZAN-BPD Reduction From Baseline at Week 10 | 22 Participants |
| BI 1358894 25mg | ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as ≥30% ZAN-BPD Reduction From Baseline at Week 10 | 28 Participants |
| BI 1358894 75mg | ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as ≥30% ZAN-BPD Reduction From Baseline at Week 10 | 34 Participants |
| BI 1358894 125mg | ZANarini Rating Scale for Borderline Personality Disorder (ZAN-BPD) Response: Defined as ≥30% ZAN-BPD Reduction From Baseline at Week 10 | 59 Participants |
Comparison: The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.95% CI: [0.207, 1.14]
Comparison: The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.95% CI: [0.829, 7.48]
Comparison: The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.95% CI: [0.698, 4.861]
Comparison: The odds ratio (OR) and associated confidence intervals between the active treatment arm versus placebo were calculated through a logistic regression model that was adjusted for fixed factors of treatment, baseline ZAN-BPD strata indicator (≤18 vs. ≥19), and the continuous covariate of baseline ZAN-BPD total score.95% CI: [0.642, 2.913]