NCT06235905已完成2 期
An Open-Label, Single-Group Study to Evaluate the Efficacy and Safety of SPN-820 in Adults With Major Depressive Disorder
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6).
研究概览
简要总结
This study will evaluate of the efficacy and safety of SPN-820 in Adults With Major Depressive Disorder (MDD)
详细描述
This is an open-label study of adjunctive SPN-820 (2400 mg) administered orally once every 3 days in adults with MDD
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subject, aged 18 to 65 years (inclusive) at screening.
- •Diagnosis of MDD according to the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5) for either recurrent or single episode MDD without psychotic features that is confirmed by the Mini International Neuropsychiatric Interview (MINI) at screening.
- •MADRS total score of ≥22 for the current major depressive episode (MDE) at screening and baseline (day 1) before study medication (SM) administration.
- •CGI-S score of ≥4 (moderately ill or worse) at screening and baseline (day 1) before SM administration.
- •Stable, therapeutic dose of one of the following protocol-defined ADTs for the current MDE for ≥6 weeks prior to screening: citalopram, escitalopram, paroxetine, fluoxetine, sertraline, duloxetine, venlafaxine (immediate release or extended release), desvenlafaxine, vilazodone, levomilnacipran, vortioxetine, bupropion, or dextromethorphan/bupropion.
- •Stable therapeutic dose of the approved ADT throughout the study.
排除标准
- •MADRS total score improvement of ≥25% from the highest to the lowest score from screening to baseline.
- •Clinically significant abnormal laboratory profiles, vital sign measurements, or ECGs prior to baseline.
- •Lifetime history of psychotic disorder, including but not limited to schizophrenia, MDD with psychotic features, or bipolar I/II disorder with and without psychotic features.
- •Diagnosis within the last 12 months before screening or current diagnosis of PTSD, OCD, panic disorder, acute stress disorder, or has a history of intellectual disability, autism, or cluster A or B personality disorder.
- •Suicidal behavior or suicidal ideation of type 4 or type 5 based on the C-SSRS in the 1 year before screening; a history of suicide attempt in the last 2 years; or more than 2 lifetime suicide attempts.
- •History of substance use disorder within 6 months prior to screening or is currently using or has a positive result (urine drug screen) at screening or baseline for drugs of abuse.
- •History of alcohol use disorder within 6 months prior to screening.
- •In the investigator's opinion, is unlikely to comply with the protocol or is unsuitable for any other reason.
研究组 & 干预措施
SPN-820 6 x 400 mg capsules
Other
干预措施: NV-5138 (Drug)
结局指标
主要结局
Change From Baseline to Each Time Point in the Hamilton Depression Rating Scale-6 Items (HAM-D6) Total Score (HAM-D6).
时间窗: 10 days (end of study)
The HAM-D6 scale consists of 6 items: five of them (depressed mood, work and activities, feeling of guilt, anxiety, psychic, retardation) are scored on a scale of 0 to 4, and one item (somatic symptoms general) is scored on a scale 0 to 2. The total score is the sum of the 6 items ranging from 0 to 22, higher scores indicate severe depression, and lower scores are better outcomes.
次要结局
- Change From Baseline to Each Time Point in the Montgomery-Åsberg Depression Rating Scale (MADRS) Total Score.(10 days (end of study))
- Change From Baseline to Each Time Point in the Clinical Global Impression - Severity of Illness Score (CGI-S).(10 days (end of study))
- Suicidal Ideation and Behavior as Measured by the Columbia-Suicide Severity Rating Scale (C-SSRS)(10 days (end of study))
- Incidence of Treatment Emergent Adverse Events(10 days (end of study))
研究者
研究点 (1)
Loading locations...
相似试验
终止
不适用
The Study to Evaluate the Safety and Efficacy of Spinal Cord Stimulation on Progressive Supranuclear PalsyProgressive Supranuclear PalsySpinal Cord StimulationNCT04367116Huashan Hospital3
已完成
1 期
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or SchizophreniaSchizophreniaBipolar I DisorderNCT04127058Vanda Pharmaceuticals12
已完成
4 期
BLQ Study: A Study of a Protease Inhibitor With Fuzeon (Enfuvirtide) in Treatment-Experienced Patients With HIV-1.HIV InfectionsNCT00326963Hoffmann-La Roche142
招募中
1 期
Safety and Clinical Activity of ThisCART22 in Patients With r/r Non-Hodgkin's B Cell LymphomaB-cell MalignancyNCT05106946Fundamenta Therapeutics, Ltd.20
招募中
1 期
Safety and Clinical Activity of ThisCART19 in Patients With r/r Non-Hodgkin's B Cell LymphomaB-cell MalignancyNCT05106907Fundamenta Therapeutics, Ltd.20