NCT00000458已完成2 期
Sertraline and Cognitive Therapy in Depressed Alcoholics
National Institute on Alcohol Abuse and Alcoholism (NIAAA)2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 1999年11月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
研究概览
简要总结
This study will assess whether individuals treated with sertraline (Zoloft) and cognitive behavior therapy will experience improvement with their depression and consume less alcohol than individuals treated with a placebo and cognitive behavior therapy. This is a 12-week, random assignment, placebo-controlled, double-blind study with followup assessments 1 and 3 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
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
- •Meets criteria for major depressive episode.
- •Meets criteria for alcohol abuse or dependence thirty days prior to entering the study.
- •Has had no more than one previous inpatient medical detoxification.
- •Able to maintain sobriety for ten days.
- •Able to read and understand questionnaires and informed consent.
- •Lives within 50 miles of the study site, has a stable living situation, and a reliable source of collateral reporting.
排除标准
- •Meets criteria for any other psychoactive substance dependence other than nicotine.
- •Any psychoactive substance abuse (other than nicotine or marijuana) within 30 days before beginning of study.
- •Meets criteria for other psychiatric disorders including: panic disorder, obsessive-compulsive disorder, bipolar affective disorder, cyclothymia, schizophrenia, any organic mental disorder, eating disorder, dissociative disorder, or post-traumatic stress disorder.
- •Has evidence of treatment resistant depression defined as more than one previous treatment episode for depression, which can include hospitalization and/or one course of antidepressant medication.
- •Patients may not have been prescribed a specific serotonergic medication within the month prior to study and may not have taken any antidepressant or antipsychotic within the two weeks prior to study.
- •Current use of disulfiram (Antabuse) or anti-seizure medications.
- •Clinically significant medical problems: cardiovascular, renal, gastrointestinal, or endocrine problems that would limit participation or limit medication ingestion.
- •Hepatocellular disease.
- •Females who are pregnant, nursing, or not using a reliable form of birth control.
- •Current charges pending for violent crime (excluding DUI related offenses).
- •Previous adverse experience with a serotonin reuptake inhibitor.
- •Current homicidal or suicidal ideation.
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
Drug Treatment for Alcoholics With Post-Traumatic Stress DisorderAlcoholismPost-Traumatic Stress DisorderNCT00000446National Institute on Alcohol Abuse and Alcoholism (NIAAA)
已完成
4 期
Sertraline for Alcohol Dependence and DepressionDepressionAlcoholismNCT00004554University of Pennsylvania171
已完成
3 期
A Randomised Trial of Sertraline, Cognitive Behaviour Therapy & Combined Therapy for Postnatal DepressionAnxietyDepressionNCT02122393University of Melbourne45
终止
4 期
Cognitive Behavioral Therapy Versus Sertraline in the Treatment of Post-Traumatic Stress DisorderPost-Traumatic Stress DisorderNCT00391430NYU Langone Health39
已完成
不适用
A study in the effects of sertraline on depressive symptoms of patients with inoperable advanced pancreatic cancerInoperable advanced pancreatic cancerJPRN-UMIN000003383agoya University Hospital30