A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of SPN-821 as an Adjunctive Therapy in Adults With Major Depressive Disorder
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.
研究概览
简要总结
This study will evaluate the efficacy and safety of SPN-821 in adults with major depressive disorder
详细描述
This is a multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of SPN-821 administered twice a week as adjunctive therapy to an approved antidepressant therapy in adult participants with MDD. The study includes a 2-week Screening Period, a 4-week Double blind Treatment Period, and a Safety Follow-up phone call one week after the completion of the Treatment Period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of MDD according to the DSM-5 for either single or recurrent MDE without psychotic features confirmed by the MINI
- •Duration of current MDE of at least 8 weeks
- •MADRS total score of ≥ 24 at the Screening Visit and Day 1 Visit
- •CGI-S score of ≥ 4 (moderately ill or worse) at the Screening Visit and Day 1 Visit
- •Stable, therapeutic dose of one of the following protocol-approved ADTs as a monotherapy for ≥ 8 weeks before the Screening Visit and ≥ 10 weeks at the Day 1 Visit. Additionally, inadequate response to the current ADT (less than 50% improvement in depressive symptoms) as confirmed by the ATRQ Investigator administered.
排除标准
- •MADRS total score change of ≥ 25% from the Screening Visit to Day 1 Visit
- •History of treatment resistant depression (TRD) defined as 3 or more failed ADTs of adequate dose (per ATRQ) and duration (at least 8 weeks) for the current MDE
- •History of alcohol or substance use disorder according to DSM-5 criteria 6 months before the Screening Visit
- •Evidence of significant risk for suicidal behavior during participation in the study in the Investigator's opinion
- •Lifetime diagnosis of any psychotic disorder including MDD with psychosis, MDD with mixed features, bipolar I/II disorder, bipolar depression, schizophrenia, posttraumatic stress disorder, autism spectrum disorder, or any personality disorder or intellectual disability that would affect the ability of the participant to enroll in the study
- •Diagnosis less then 12 months before screening of severe obsessive-compulsive disorder, acute stress disorder, panic disorder, eating disorders, or any other psychiatric condition that has been the primary focus of treatment, or diagnosis of generalized anxiety disorder less then 6 months before screening.
- •History of cardiovascular, respiratory, gastrointestinal, renal, hepatic, and hematologic disorders, or other medical disorders that could impose undue risk or compromise the study in the Investigator's opinion
- •Clinically significant abnormal result prior to Day 1 Visit per Investigator's judgment or abnormal renal function.
- •Requires treatment with a medication or other substance that is prohibited by the protocol.
研究组 & 干预措施
SPN-821 2400 mg
Three 800 mg oral tablets administered twice a week adjunctive to current antidepressant
干预措施: SPN-821 2400 mg (Drug)
Placebo
Three oral tablets administered twice a week adjunctive to current antidepressant
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline to Day 29 in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.
时间窗: 4 weeks
MADRS is a 10-item scale (Reported sadness, Apparent sadness, Inner tension, Reduced sleep, Reduced appetite, Concentration difficulties, Lassitude, Inability to feel, Pessimist thoughts, and Suicidal thoughts) where each item is scored from 0 to 6. The total score is the sum of the 10 items ranging from 0 to 60 where higher scores indicate more severe depression, and lower scores are better outcomes.
次要结局
- Change From Baseline to Day 29 in the Clinical Global Impression - Severity of Illness Score (CGI-S).(4 weeks)