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 RCV GmbH & Co KG0 个研究点目标入组 355 人开始时间: 2020年7月27日最近更新: 2021年11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, 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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