A Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Monotherapy Study of the Efficacy, Safety, and Tolerability of SPT-300 in Adults With Major Depressive Disorder (MDD), With or Without Anxious Distress
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 66
- 主要终点
- Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score
研究概览
简要总结
This is a randomized, parallel-group, double-blind, placebo-controlled, monotherapy study to evaluate the efficacy, safety, and tolerability of SPT-300 (GlyphAllo) in adults with major depressive disorder (MDD), with or without anxious distress.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Participant is a male or female between 18 and 65 years of age, inclusive willing and able and have capacity to provide written informed consent.
- •Participants must have a primary diagnosis of MDD. Participants with a diagnosis of comorbid generalized anxiety disorder, social anxiety disorder, or panic disorder (with or without agoraphobia) may be included if not the focus of treatment over the past 6 months prior to Screening and the Investigator considers MDD to be the primary diagnosis at Screening and Baseline.
- •Eligible participants must have a current depressive episode of at least 4 weeks, but no greater than 18 months in duration prior to Screening.
- •Women of childbearing potential (WOCP) must not plan to become pregnant during the course of the study or be currently breastfeeding. WOCP agree to use an acceptable form of highly effective contraception during participation in the study and for 30 days after receiving the last dose of study treatment.
- •Body mass index (BMI) between 18 to 40 kg/m2, inclusive.
- •Participant is willing and able to refrain from the use of drugs of abuse.
排除标准
- •History of, or current presentation consistent with:
- •any depressive episode with psychotic or catatonic features.
- •any bipolar manic, hypomanic or mixed episode, and substance-induced (e.g., antidepressant-induced) manic, hypomanic/mixed episode.
- •bipolar disorder, including history of bipolar depression, or current presentation consistent with bipolar depression.
- •schizophrenia, schizoaffective, or other psychotic disorder.
- •obsessive-compulsive disorder.
- •any persistent neurocognitive disorder.
- •History of treatment-resistant depression defined as 2 or more failed treatments of adequate dose and duration in the current depressive episode.
- •Psychiatric hospitalization within current depressive episode.
- •Evidence or history of clinically significant diseases which can affect the patients' participation.
- •Previous history of intolerance or significant adverse effects, including drug allergy to allopregnanolone or any components of the SPT-300/placebo formulation.
- •Participant has a history of drug or alcohol use disorder.
- •Participants with a positive test for cannabinoids.
- •Clinically significant risk of suicide or harm to self or others.
研究组 & 干预措施
Placebo
Participants will receive matching placebo once daily for 42 days
干预措施: Placebo (Drug)
SPT-300
Participants will receive SPT-300 capsules once daily for 42 days
干预措施: SPT-300 (Drug)
结局指标
主要结局
Change From Baseline to Day 42 in Hamilton Depression Rating Scale-17 (HAM-D-17) Total Score
时间窗: Baseline (Day 0) to Day 42
HAM-D-17 is a 17-item, clinician-administered rating scale to assess the severity of symptoms in participants diagnosed with depression. The HAM-D-17 comprises individual ratings related to the following symptoms: depressed mood (sadness, hopeless, helpless, worthless), feelings of guilt, suicide, insomnia (early, middle, late), work and activities, retardation (slowness of thought and speech; impaired ability to concentrate; decreased motor activity), agitation, anxiety (psychic and somatic), somatic symptoms (gastrointestinal and general), genital symptoms, hypochondriasis, loss of weight, and insight. HAM-D Total Scores range from 0 to 52, with higher scores indicating more severe depression.
次要结局
- Change From Baseline to Day 42 in Clinical Global Impression - Severity (CGI-S)(Baseline (Day 0) to Day 42)