EUCTR2021-006861-39-NL进行中（未招募）1 期
A Phase 2 Clinical Trial of GH001 in Patients with Bipolar II Disorder and a Current Major Depressive Episode(GH001-BD-202)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- •Is male or female and in the age range between 18 and 64 years (inclusive) at screening;
- •Meets the trial criteria for bipolar II disorder and is experiencing a major depressive episode:
- •Meets the DSM-5 diagnostic criteria for bipolar II disorder with a current major depressive disorder episode confirmed by the Mini-International Neuropsychiatric Interview (MINI) v7.0.2
- •Has a Montgomery–Åsberg Depression Rating Scale (MADRS) total score of = 24 at screening and pre-dose on Day 0
- •Has a Young Mania Rating Scale (YMRS) total score = 8 at screening and prior to first dose on Day 0;
- •Agrees to keep any psychotherapy unchanged, and not initiate any new psychoactive medications during the trial;
- •Male patients must use prophylactic contraception (i.e., condom with spermicide or abstinence) and must not donate sperm for 30 days after GH001 dosing;
- •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 15
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Has bipolar II disorder with rapid cycling (four or more episodes of hypomania or depressive episodes in previous 12-month period);
- •Has, based on history, psychiatric assessment, and evaluation of the MINI, a current or prior diagnosis of bipolar I disorder, a manic episode, a psychotic disorder, major depressive disorder (MDD) or other mood disorder with psychotic features, obsessive compulsive disorder, PTSD, autism spectrum disorder, borderline personality disorder, clinically significant intellectual disability or any other psychiatric comorbidity that renders the patient unsuitable for the trial according to the investigator’s judgment;
- •Has one or more first or second degree relatives with a current or previously diagnosed psychotic disorder or MDD with psychotic features;
- •Is in the judgment of a trial psychiatrist or registered psychologist, at significant risk for suicide based on history, psychiatric assessment, and evaluation of suicidal ideation and suicidal behaviour based on the C-SSRS;
- •Has had an inadequate response to an adequate course of electroconvulsive therapy, vagal nerve stimulation, repetitive transcranial magnetic or electrical stimulation, or deep brain stimulation in the current episode of depression as assessed using the ATHF-SF;
- •Female patient who has a positive pregnancy test at screening or on the pre-test day (Day -1), is pregnant or lactating, or plans to become pregnant during the course of the trial and up to 30 days after GH001 dosing;
- •Patients with DSM-5 drug or alcohol use disorder within 6 months prior to screening.
研究者
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