EUCTR2021-002126-24-HR进行中（未招募）1 期
A Multi-region, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Evaluating SEP-4199 Controlled Release (CR) for the Treatment of Major Depressive Episode Associated with Bipolar I Disorder (Bipolar I Depression)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 522
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1.Subject provides written informed consent and is willing and able to comply with the protocol in the opinion of the Investigator.
- •2.Subject or legally acceptable representative must possess an educational level and degree of understanding of English or the local language that enables them to communicate suitably with the Investigator and the study coordinator.
- •3.Subject is 18 to 65 years of age, inclusive, at the time of informed consent.
- •4.Subject meets DSM-5 criteria, based on the SCID-5-CT, for bipolar I disorder, current episode depressed with or without rapid cycling disease course (= 4 episodes of mood disturbance but < 8 episodes in the previous 12 months) with or without psychotic features.
- •5.Subject has a lifetime history of at least 1 manic episode or manic episode with mixed features corroborated by medical records.
- •6.Subject’s current major depressive episode is corroborated by medical records.
- •7.Subject’s current major depressive episode is = 4 weeks and less than 12 months in duration at Screening.
- •8.Subject has a MADRS-S total score = 22 at Screening.
- •9.Subjecthas a MADRS total score = 22 at both Screening and Baseline.
- •10.Subject has a CGI-BP-S depression score = 4 at both Screening and Baseline.
- •11.Subject has a YMRS total score = 12 at both Screening and Baseline.
- •Please refer to Protocol for the complete list.
- •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 522
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Subject currently has any DSM-5 defined psychiatric diagnosis other than bipolar I disorder that was the primary focus of treatment in the past 6 months prior to Screening.
- •2.Subject has a lifetime history of, or symptoms consistent with, a major psychiatric diagnosis other than bipolar I disorder. These include (but are not limited to): schizophrenia, schizoaffective disorder, obsessive-compulsive disorder, or post-traumatic stress disorder. (Note: Subjects with a previous diagnosis of major depressive disorder or bipolar II disorder that was subsequently changed to bipolar I disorder are allowed.)
- •3.Subject has a history within the past 12 months prior to Screening of substance use disorder or moderate-to-severe tobacco (nicotine) use disorder. (Note: mild tobacco use disorder is acceptable.)
- •4.Subject has confirmed or suspected borderline personality disorder.
- •5.Subject demonstrates a decrease (improvement) of = 25% in MADRS total score from Screening to Baseline.
- •6.Subject is considered by the Investigator to be at imminent risk of suicide or injury to self or others, or has a score = 4 on MADRS item 10 (suicidal ideation) or answers yes” to suicidal ideation” item 4 (active suicidal ideation with some intent to act, without specific plan) or item 5 (active suicidal ideation with specific plan and intent) on the C-SSRS assessment at the Screening Visit (in the past 3 months [90 days]) or at Baseline.
- •7.Subject has received any psychotropic medication or herbal supplement within 3 days or 5 half-lives (whichever is longer) prior to Baseline or anticipates the need for psychotropic medications or herbal supplements during participation in this study, with the exception of the medications specified in Protocol Section 10.3. The following treatments have additional restrictions as specified below:
- •a.Monoamine oxidase inhibitors (MAOIs) must be discontinued at least 28 days prior to Baseline.
- •b.Fluoxetine, and olanzapine/fluoxetine combination must be discontinued at least 28 days prior to Baseline.
- •c.Clozapine used at 200 mg/day or less for insomnia, agitation, or anxiety must be discontinued at least 28 days prior to Baseline. Subjects with a history of treatment with clozapine for any reason at doses greater than 200 mg/day or at doses less than or equal to 200 mg/day for a usage other than insomnia, agitation, or anxiety are excluded from study participation.
- •d.Depot neuroleptics must have been discontinued at least one treatment cycle or at least 30 days (whichever is longer) prior to Baseline.
- •e.Subject has received esketamine within 60 days prior to Baseline.
- •f.Electroconvulsive therapy (ECT) or repetitive transcranial magnetic stimulation (rTMS) within 90 days prior to Baseline.
- •g.Subjects with a history of treatment with vagus nerve stimulation (VNS) or deep brain stimulation (DBS) are excluded from study participation.
- •8.Subject initiated a new psychotherapeutic intervention (eg, psychotherapy) focused on treatment of bipolar I depression within the past 12 weeks prior to Screening. (Note: Subjects who have participated in ongoing psychotherapy treatment for at least 12 weeks prior to Screening will be permitted to continue this treatment during the study.)
- •9.Subject has a history of non-response to an adequate (6-week) trial of 3 or more antidepressants (with or without mood stabilizers) during the current major depressive episode.
- •10.Subject was hospitalized during the Screening Period without explicit approval by the Me
研究者
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