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

Boehringer Ingelheim Pharma GmbH & Co. KG0 个研究点目标入组 355 人开始时间: 2020年7月29日最近更新: 2024年1月8日

研究概览

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•- Patients meeting diagnostic criteria of BoPD per DSM-5 at screening visit, confirmed by SCID-5-PD.
•- 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)1 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.
•- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 340
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•- 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 (in addition to those described in Exclusion 1 and 2) 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 (e.g. DBT, cognitive behavior therapy (CBT), Interpersonal therapy) for BoPD within the last 3 months prior to screening. Patients with ongoing, stable psychotherapy >3 months prior to Screening (and intend to maintain the same frequency during the study) may qualify as per clinical judgement of the investigator.
•- Any ongoing use of psychotropic medications within 7 days prior to randomization or during the course of study (unless allowed per protocol, see Section 4.2.2.1). Investigators may use their clinical discretion to wash out (at least 3 half-lives of referenced medication) psychotropic medications during screening period. Such wash-out of ongoing psychotropic medication must complete at least 7 days prior to randomization.
•- Further criteria apply.

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