NCT05439603已完成2 期
A Phase 2 Study of ANC-501 in the Treatment of Adults With Major Depressive Disorder
Ancora Bio, Inc. d/b/a EmbarkNeuro, Inc.8 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2022年9月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 8
- 主要终点
- Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
研究概览
简要总结
A Phase 2 Study of ANC-501 in the treatment of adults with Major Depressive Disorder
详细描述
This is a single-arm, open-label Phase 2 study to assess the safety, tolerability, pharmacokinetics (PK), and activity of ANC-501 oral capsules as adjunctive treatment in subjects diagnosed with major depressive disorder (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
- •Adult male or female between 18 and 65 years of age, inclusive.
- •Diagnosis of current episode of major depressive disorder (MDD) at least 8 weeks prior to screening, confirmed by Structured Clinical Interview for DSM-5 - Clinical Trials Version (SCID-5-CT).
- •Have not responded to their current antidepressant therapy or to dose adjustment/treatment changes following a loss of response to their current antidepressant therapy.
- •Receiving a stable dose of the same antidepressant (selective serotonin reuptake inhibitor [SSRI] or serotonin and norepinephrine reuptake inhibitor [SNRI], bupropion or trazodone monotherapy) for the current episode for at least 6 weeks of continuous treatment, which can include some or all of the screening period, with 4 weeks on a stable dose prior to day 1 and has an inadequate response (<50% improvement) using the MGH ATRQ.
- •MADRS total score of ≥26 at screening and Day 1 (prior to dosing).
- •12-hour urine cortisol level >22.7 nmol/L(greater than or equal to 8.3 mcg/L).
排除标准
- •Inadequate response to >2 prior ADTs (not including current antidepressant) of at least 6 weeks duration each for the episode current at screening.
- •Medical history of bipolar disorder, schizophrenia, and/or schizoaffective disorder.
- •Administration of drugs to treat psychiatric or neurologic conditions that have not been taken at a stable dose for at least 4 weeks prior to day
- •Significant findings on ophthalmic examination including, Best Corrected Visual Acuity (BCVA) worse than 20/30 or, in the opinion of the ophthalmologist or optometrist, any cataract that may become clinically significant and/or need surgical intervention during the course of the trial.
研究组 & 干预措施
ANC-501
Experimental
50 mg/day
干预措施: ANC-501 (Drug)
结局指标
主要结局
Mean Change From Baseline (Day 1) to Day 56 in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
时间窗: Baseline (Day 1) to Day 56
The MADRS was utilized as the primary efficacy assessment of the participant's level of depression. The MADRS consists of 10 items, all rated on a scale 0 to 6 with 0 being the "best" rating and 6 being the "worst" rating. The MADRS Total Score is the sum of ratings for all 10 items. Total MADRS score range is 0 to 60. A higher score indicates more severe depression.
次要结局
- Mean Change From Baseline (Day 1) in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at All Timepoints.(Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70)
- Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Response.(Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70)
- Percentage of Participants With Montgomery Asberg Depression Rating Scale (MADRS) Remission.(Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70)
- Mean Change From Baseline (Day 1) to Day 56 in Hamilton Anxiety Scale (HAM-A) Total Score.(Baseline (Day 1) to Day 56)
- Mean Change in Clinical Global Impression-Severity (CGI-S) Score From Baseline (Day1) to Day 56.(Baseline (Day1) to Day 56)
- Percentage of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement(Baseline (Day1), Day 8, Day 15, Day 29, Day 43, Day 56, and Day 70)
- Number of Participants With Clinical Global Impression-Improvement (CGI-I) Improvement(Baseline (Day1) to Day 56)
研究者
研究点 (8)
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