A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Assessment of the Efficacy, Safety and Tolerability of CX157 Modified Release Tablet, 125 mg Twice Per Day in Subjects With Treatment Resistant Depression
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 360
- 试验地点
- 29
- 主要终点
- Montgomery Asberg Depression Rating Scale (MADRS)
研究概览
简要总结
The purpose of this study is to determine if CX157 is effective and safe in patients with treatment of treatment resistant depression over six weeks of treatment.
详细描述
The primary objective of this study is to examine the efficacy of CX157 Modified Release Tablet, 125 mg administered twice per day (BID) as compared to placebo in subjects with Treatment Resistant Depression (TRD). Secondary objectives are to evaluate the safety and tolerability of CX157 Modified Release Tablet, 125 mg BID in TRD subjects and characterize steady-state pharmacokinetic profile and explore pharmacodynamic relationships.
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
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 20 to 65 years of age
- •Able to read, understand and converse in English and provide written, dated informed consent
- •Diagnosed with Major Depressive Disorder (MDD)and Treatment Resistant Depression(TRD)
- •Females on acceptable method of contraception
排除标准
- •Major depressive episode greater than five years
- •A history of a Substance Use Disorder with the exception of nicotine dependence in the past 12 months
- •Obsessive-Compulsive Disorder (OCD), Panic Disorder, Post-traumatic Stress Disorder (PTSD
- •A history of schizophrenia or schizoaffective disorders
- •A history of anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified, within the past five years
- •A history of Antisocial Personality Disorder or Borderline Personality Disorder
- •Recent suicidal behavior and is at risk of such behavior during the course of the study
- •Electroconvulsive therapy (ECT) within the past five years
- •Transcranial Magnetic Stimulation (TMS) for the treatment of the current episode of depression
- •Vagus Nerve Stimulation (VNS) at any time
- •Any psychoactive drugs within one to four weeks prior to the randomization visit depending on the type of drug
- •Significant abnormality on the screening physical examination
- •Significant cardiac abnormalities such as uncontrolled hypertension, recent myocardial infarction, Congestive heart failure (CHF), Angina pectoris
- •A history within the past two years of significant head trauma, surgical procedure involving the brain,degenerative central nervous system disorder (e.g., Alzheimer's or Parkinson's Disease), epilepsy, mental retardation
- •A history of hypothyroidism and has been on a stable dosage of thyroid replacement medication for less than six months
- •A history of hyperthyroidism which was treated (medically or surgically) less than six months prior to screening
- •Participation in an investigational study in the past one month
- •A positive screening urine test for drugs of abuse
- •Female subject who is pregnant or lactating
研究组 & 干预措施
CX157 (TriRima)
CX157 (TriRima) in a reversible monoamine oxidase inhibitor (MAOI)
干预措施: CX157 (TriRima) (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Montgomery Asberg Depression Rating Scale (MADRS)
时间窗: Over six weeks of study treatment
The MADRS will be administered by a trained rater at the study site and assess symptoms of depression.
次要结局
- Severity of illness (CGI-S);(Over six weeks of treatment with study drug.)
- Global Improvement (CGI-I)(Over six weeks of treatment)
- Hospital Anxiety Depression Rating Scale (HADS)(over six weeks of treatment)