A Phase 2 Double-blind, Randomised, Placebo-controlled Trial to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of DT-101 in Adults With Major Depressive Disorder Receiving Pharmacological Therapy for Depression
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 118
- 试验地点
- 23
- 主要终点
- Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56
研究概览
简要总结
In this study, researchers will learn more about a study drug called DT-101 in participants with Major Depressive Disorder (MDD), a form of depression. The goal of this clinical trial is to learn if DT-101 can treat depression in adults. The effect of DT-101 will be compared to placebo. A placebo looks the drug but contains no medicine. Subjects will attend the clinic for complete general health checks and to complete questionnaires.
详细描述
The purpose of this study is to compare DT-101 and placebo in adult participants with MDD already receiving medication for depression. The clinical study will also evaluate how safe and well tolerated the study drug is. Potential participants will be assessed if they are suitable to take part in the clinical research study by performing physical and neurological examinations, obtaining blood and urine samples, conducting clinical assessments and reviewing medical and treatment history. After successfully passing screening into the study, participants will be randomly assigned to receive either DT-101 or placebo for the study. Over the next 8 weeks, these tests and assessments will continue throughout the study with the purpose of checking the participants' ongoing suitability and to collect data to analyse the effect that DT-101 may have on their depression symptoms. Participants will also have blood samples taken to allow analysis of how DT-101 is absorbed and used by the body.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The participant is able to read, understand and communicate in the local language used at the study site, and is willing to provide written informed consent
- •Male or female (assigned at birth, inclusive of all gender identities) participant must be 18 to 75 years of age, inclusive at the time of signing the informed consent.
- •Has recurrent depression (defined as at least one prior episode excluding the current one), as diagnosed by DSM 5-TR (Diagnostic and Statistical Manual of Mental Disorders, 2022).
排除标准
- •Pregnant or breastfeeding or plans to become pregnant during the study.
- •Unstable medical condition or unstable chronic disease.
- •Significant neurological abnormality.
- •History of moderate or severe alcohol or drug use disorder as per DSM-5-TR in the 6 months prior to Screening.
- •History of seizure.
- •In the investigator's opinion, the participant is not capable of adhering to the protocol requirements.
研究组 & 干预措施
DT-101
干预措施: DT-101 (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline in total Montgomery Åsberg depression rating scale (MADRS) score, at Day 56
时间窗: from enrolment to day 56
次要结局
- Change from baseline in Clinician Global Impression of severity (CGI-S), at Day 56(from enrolment to day 56)