Riluzole Augmentation Pilot in Depression (RAPID) Trial
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Mean Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks
研究概览
简要总结
The investigators are doing a research study to find out if riluzole, when taken along with a standard antidepressant (sertraline) can help people with major depression.
This research study will compare riluzole + sertraline to placebo + sertraline. The investigators hypothesize that adding riluzole will lead to a better antidepressant response, in less time, then sertraline alone.
详细描述
Recent attention has focused on the glutamatergic system as a new, distinct target for depression treatment. Riluzole (Rilutek, Sanofi), an oral modulator of glutamate activity with neuroprotective and anticonvulsant properties, is currently approved by the United States Food and Drug Administration for treatment of amyotrophic lateral sclerosis (ALS). Preliminary studies using riluzole to treat depression in humans are promising, though larger, double-blinded controlled trials are needed.
Overall study population:
Adult outpatients with a current, untreated major depressive episode.
Disallowed therapies include: other psychotropic medications, including antipsychotics, mood stabilizers, benzodiazepines, barbiturates, other sedative-hypnotics, chronic opiates, or additional antidepressants, psychotherapy, electroconvulsive therapy, vagal nerve stimulations therapy, transcranial magnetic stimulation therapy, or phototherapy.
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 (Participant, 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
- 是
入选标准
- •Adults (ages 18-75) who meet DSM-IV criteria for a major depressive episode,
- •Hamilton Depression Rating Scale (HDRS) >22, and
- •No antidepressant treatment for at least three weeks
排除标准
- •Active drug or alcohol disorder in the past 3 months
- •History of psychosis, history of mania or hypomania
- •Epilepsy or history of seizures
- •Hypothyroidism
- •Congenital QTc prolongation
- •Liver disease
- •Lung disease
- •Acute suicide or homicide risk
- •Pregnant women, breastfeeding women, women of childbearing age not using contraception
- •Unstable medical illness
- •Elevated thyroid-stimulating hormone (TSH>5.0mlU/L), or
- •Abnormal liver function tests (ALT>50 U/L or AST>50 U/L)
- •ADD / ADHD (Attention deficit hyperactivity disorder)
- •Disallowed therapies include: other psychotropic medications, including antipsychotics, mood stabilizers, benzodiazepines, barbiturates, other sedative-hypnotics, chronic opiates, or additional antidepressants, psychotherapy, electroconvulsive therapy, vagal nerve stimulations therapy, transcranial magnetic stimulation therapy, or phototherapy.
研究组 & 干预措施
sertraline + placebo
sertraline 100 mg po daily and placebo
干预措施: placebo (Other)
sertraline + placebo
sertraline 100 mg po daily and placebo
干预措施: Sertraline (Drug)
sertraline + riluzole
sertraline 100 mg po daily and riluzole 50 mg po bid
干预措施: Riluzole (Drug)
sertraline + riluzole
sertraline 100 mg po daily and riluzole 50 mg po bid
干预措施: Sertraline (Drug)
结局指标
主要结局
Mean Change in Hamilton Depression Rating Scale (HDRS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks
时间窗: 0 weeks-8 weeks
The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52.
Number of Patients Experiencing an Antidepressant Response (>50% Reduction in HDRS) at Endpoint of 8 Weeks
时间窗: 0 weeks-8 weeks
The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52.
Number of Patients Experiencing Remission From Depression (HDRS<7) at Endpoint of 8 Weeks
时间窗: 0 weeks-8 weeks
The Hamilton Depression Rating Scale (HDRS) is a clinician-administered semi-structured interview with 17 questions. It is designed to measure the severity of depressive symptoms in patients with a primary depressive illness. Higher HDRS scores indicate a worse outcome. The scale has a minimum value of 0 and a maximum value of 52.
次要结局
- Mean Change in Hamilton Anxiety Rating Scale (HARS) Score From Baseline (0 Weeks) to Endpoint at 8 Weeks(0 weeks-8 weeks)
- Mean Change in Clinical Global Impression (CGI) Scale From Baseline (0 Weeks) to Endpoint at 8 Weeks(0 weeks-8 weeks)
研究者
Jessica Harder
Physician
Brigham and Women's Hospital