EUCTR2020-000078-12-IT进行中（未招募）1 期
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 ITALIA S.P.A.0 个研究点目标入组 355 人开始时间: 2020年11月6日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 355
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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 ICHGCP
- •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
排除标准
- •- 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.
研究者
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