NCT06236880招募中2 期
A Phase 2a Study to Evaluate the Safety and Tolerability of Two Repeated Doses of GM-2505 at a 2-Week Interval in Patients With Major Depressive Disorder.
Gilgamesh Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2024年1月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Safety and Tolerability (Part A, B, and C)
研究概览
简要总结
This is a three-part Phase 2a study. The aim of Part A is to assess the safety and tolerability and preliminary antidepressant efficacy in patients with MDD who are not currently on an antidepressant therapy. The aim of Part B is to assess the antidepressant efficacy, safety and tolerability in patients with MDD who are partial responders while on a current and adequate single SSRI or SNRI treatment. Part C aims to replicate the monotherapy findings of Part A, but with a lower control group dose.
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
- •Patients are male or female, of any ethnic origin.
- •Patients are aged between 18 to 65 years, inclusive.
- •Patients meet the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for recurrent MDD without psychotic features, as assessed with the Mini-International Neuropsychiatric Interview (MINI) at Screening.
- •Current moderate to severe MDD diagnosis confirmed with a MADRS-SIGMA
- •Concomitant depression therapy:
- •(Part A) Patients need to be stable and must not have taken any SSRI or SNRI for at least 6 weeks prior to Screening and must be willing to avoid starting a new pharmacological treatment for MDD until the end of the study procedures and assessments. Discontinuing current treatment is not allowed if done for the purposes of achieving eligibility for this study.
- •(Part B) Patients need to be on stable treatment with any SSRI or SNRI for at least 6 weeks prior to screening and must be willing to remain on the SSRI or SNRI for the duration of the trial
- •Patients receiving any form of psychotherapy or counselling must have been receiving therapy at Screening and must be willing to remain in therapy until the end of the study procedures and assessments.
排除标准
- •Patient has current or past primary DSM-5 diagnosis of a psychotic disorder or MDD with psychotic features, bipolar, or related disorders. A current diagnosis of PTSD, complex PTSD and borderline personality disorder are exclusionary. Other psychiatric disorders besides MDD should not be the primary disorder.
- •In first degree relatives, a history of schizophrenia, psychosis, bipolar disorder, delusional disorder, paranoid personality disorder or schizoaffective disorder.
- •Current or prior (six weeks before Screening) use of any SSRI/SNRI medication (Part A only).
- •Current or prior (five weeks before Screening) use of any monoamine oxidase inhibitor ([MAO-I]; including phenelzine, tranylcypromine, isocarboxazid, iproniazid, selegiline, rasagiline, the reversible MAO-I moclobemide and the antibiotic linezolid).or any tricyclic antidepressant
研究组 & 干预措施
Low Dose to High Dose of GM-2505
Experimental
干预措施: GM-2505 (Drug)
Moderate Dose to High Dose of GM-2505
Experimental
干预措施: GM-2505 (Drug)
Experimental very low dose to very low dose of GM-2505
Active Comparator
干预措施: GM-2505 (Drug)
结局指标
主要结局
Safety and Tolerability (Part A, B, and C)
时间窗: 99 Days
The primary objective of this study is to evaluate the safety and tolerability of two doses of GM-2505 administered to MDD patients at a 2-week interval between doses.
MADRS Score (Part B and C)
时间窗: 29 Days
The estimated difference between Arm 1 and Arm 2 in the changes from baseline in MADRS-SIGMA total score
次要结局
- MADRS-SIGMA total score (Part A)(Days 14 and 29)
- MADRS-SIGMA total score (Part B and C)(All additional timepoints)
- MADRS-SIGMA total score (Part B and C)(Days 14, 29, 43, 71, and 99)
- PK of GM-2505 (Part C)(Day 16)
研究者
研究点 (1)
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