EUCTR2021-002126-24-SK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)
适应症
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 clinical trial of medicinal product
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
- •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 at least one of the
- •following: medical records, documented correspondence with a treating psychiatrist or mental healthcare provider/staff, or information from a reliable informant who is familiar with the subject's psychiatric history. The adequacy of the information will be assessed by the Sponsor
- •Eligibility Committee.
- •6. Attempts should be made to obtain supporting information regarding
- •the subject's current major depressive episode from additional sources.
- •This may include relevant medical records and/or documented
- •correspondence with a treating psychiatrist or mental healthcare
- •provider/staff if the subject has been evaluated during the current MDD
- •episode, or information from a reliable informant who is familiar with the
- •subject's recent psychiatric history.
- •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. Subject has a MADRS total score = 22 at both Screening and Baseline.
- •10. Subject has a CGI-BP-S depression score = 4 at both Screening and
- •11. Subject has a YMRS total score = 12 at both Screening and Baseline.
- •12. Subjects meets an additional inclusion criterion at Baseline that will
- •remain blinded to clinical site Investigators and staff.
- •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 512
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
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 or is
- •currently being treated with concomitant medication.
- •2. Subject has a lifetime history of, or symptoms consistent with,
- •schizophrenia, schizoaffective disorder, or a major psychiatric diagnosis
- •other than bipolar I disorder that is judged to pose risk to the study
- •scientific objectives based on the judgement of the Investigator or the
- •Sponsor Eligibility Committee. A lifetime history of anxiety disorders,
- •attention-deficit/hyperactivity disorder (ADHD), and post-traumatic
- •stress disorder (PTSD) are not exclusionary if the disorder does not meet
- •Exclusion Criterion 1. (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.
- •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 (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
- •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
- •e. Subjects with a history of treatment with ketamine, esketamine,
- •arketamine, or psychedelic therapies (eg, psilocybin,
- •methylenedioxymethamphetamine [MDMA]) for MDD or any psychedelic
- •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.
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研究者
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