NCT05686408已完成2 期
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy, Safety, and Tolerability of TNX-601 ER Monotherapy Versus Placebo in Patients With Major Depressive Disorder (MDD)
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
- 132
- 试验地点
- 27
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy, safety, and tolerability of TNX-601 ER monotherapy versus placebo in patients with Major Depressive Disorder (MDD).
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
- •Female or male aged 18 to 65 years (inclusive).
- •Have a primary DSM-5 diagnosis of current MDD.
- •The duration of the current MDE must be at least 12 weeks.
- •Without psychotic or catatonic features.
排除标准
- •Psychiatric History:
- •Diagnosis of DSM-5-defined lifetime bipolar disorder (I, II, or unspecified), schizophrenia, schizoaffective disorder, MDD with psychotic features, other psychotic disorder, or antisocial personality disorder; current (past month) obsessive-compulsive disorder; current (past month) posttraumatic stress disorder; current (past 3 months) anorexia nervosa; lifetime opioid or lifetime sedative-hypnotic use disorders, as confirmed by the MINI 7.0.
- •Diagnosis of borderline personality disorder
- •Patients with comorbid generalized anxiety disorder (GAD), social anxiety disorder (SAD), or panic disorder are excluded only if the GAD, SAD, or panic disorder is considered the primary psychiatric diagnosis, rather than MDD. (If MDD is the primary diagnosis, patients with comorbid GAD, SAD, and panic disorder are allowed for randomization).
- •Patients with treatment refractory MDD, ie, previously having in their lifetime failed ≥2 treatments with at least 2 different classes of antidepressants of adequate dose, duration, and treatment adherence
研究组 & 干预措施
TNX-601 ER, 39.4 mg
Experimental
1x TNX-601 ER, 39.4 mg, tablet taken orally once daily for 6 weeks.
干预措施: TNX-601 ER (Drug)
Placebo
Placebo Comparator
Placebo tablet taken orally once daily for 6 weeks.
干预措施: Placebo (Drug)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: Day 1 and Week 6
Change from Baseline (Visit 2) in the MADRS total score at Week 6. Scores range from 0 to 60. Lower scores indicate less depression.
次要结局
- Clinical Global Impression of Severity (CGI-S)(Day 1 and Week 6)
- Sheehan Disability Scale (SDS)(Day 1 and Week 6)
研究者
研究点 (27)
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