EUCTR2019-004264-21-SK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.
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 = 24 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 = 4 weeks at the screening visit, with a protocol specified SSRI or SNRI or bupropion 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, confirmed by the investigator
- •- Signed and dated written informed consent in accordance with ICH-GCP 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).
- •- Have received electroconvulsive therapy and/or administration of Ketamine /S-Ketamine for the current ongoing depressive episode and/or transcranial magnetic stimulation (TMS) for the current ongoing depressive episode or within 12 months prior to screening.
- •- Have a lifetime history of vagal nerve stimulation or psychosurgery.
- •- Further criteria apply
研究者
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