EUCTR2019-004264-21-CZ进行中（未招募）1 期
A Phase II, 6-week, multicenter, randomized, double-blind,double-dummy, placebo-controlled, parallel group trial with aquetiapine arm to evaluate the efficacy, tolerability and safety oforal BI 1358894 in patients with Major Depressive Disorder withinadequate response to antidepressants.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 431
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
- •- Established diagnosis of Major Depressive Disorder (MDD), single episode or recurrent, as confirmed at the time of screening by the Structured Clinical Interview for DSM-5 (SCID-5), with a duration of current depressive episode = 8 weeks and = 18 months at the time of screening visit.
- •- Montgomery-Åsberg Depression Rating Scale (MADRS) total score = 24 at screening, as confirmed by a trained site based rater AND interactive, computer administered MADRS. The difference in the rater and computer administered MADRS must not exceed more than 7 points (for details refer to section 6.2). In addition, trial participants must have a score of = 3 on the Reported Sadness Item on both MADRS scales (computeradministered and rater-administered MADRS).
- •- A documented ongoing monotherapy treatment of = 6 weeks at the screening visit, with a protocol specified SSRI or SNRI at adequate dose
- •(at least minimum effective dose as per prescribing information and as confirmed per detectable drug levels in the screening blood sampling).
- •- Male and female participants, 18 to 65 years of age, both inclusively at the time of consent.
- •- Women of childbearing potential (WOCBP) able and willing to use two methods of contraception
- •- Signed and dated written informed consent in accordance with ICHGCP and local legislation prior to admission to the trial.
- •- Able to communicate well, and to understand and comply with trial requirements.
- •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 409
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 22
排除标准
- •- Per DSM-5, had ever met diagnostic criteria for schizophrenia, schizoaffective disorder,
- •schizophreniform disorder, bipolar disorder, delusional disorder or MDD with psychotic
- •features as assessed by the SCID-5 at the time of screening.
- •- Diagnosis of any other mental disorder (in addition to those described above)that was primary focus of treatment within 6 months prior to screening or at baseline (as per
- •clinical discretion of the investigator).
- •- Diagnosis with antisocial, paranoid, schizoid or schizotypal personality disorder as per
- •DSM-5 criteria, at the time of screening visit. Any other personality disorder at screening visit that significantly affects current psychiatric status and likely to impact trial
- •participation, as per the judgement of investigator.
- •- Diagnosis of a substance related disorder within 3 months prior to screening visit (with
- •exception of caffeine and tobacco).
- •- History of seizure disorders, stroke, brain tumor or any other major neurological illness
- •that can impact participation in the trial.
- •- History of more than 2 unsuccessful monotherapy treatments (at adequate dosage and
- •duration, per local prescribing information of the product) with an approved
- •antidepressant medication for the current ongoing major depressive episode. These
- •include ongoing monotherapy treatment with a protocol specified SSRI or SNRI as
- •described in inclusion criterion #3.
- •- Any suicidal behavior in the past 12 months prior to screening (per investigator
- •judgement including an actual attempt, interrupted attempt, aborted attempt, or
- •preparatory acts or behaviour).
- •- Any suicidal ideation of type 4 or 5 in the Columbia Suicide Severity Rating Scale (CSSRS)
- •in the past 3 months prior to screening or at screening or baseline visit (i.e. active
- •suicidal thought with method and intent but without specific plan, or active suicidal
- •thought with method, intent and plan).
- •- Further criteria apply
研究者
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