An Open-Label Pilot Study of Desvenlafaxine for Opioid-Dependent Patients With Comorbid Depression
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Tolerability: Systematic Assessment for Treatment Emergent Events (SAFTEE)
研究概览
简要总结
Background: Although substitution therapy has been shown to be highly effective to retain opioid-dependent patients in treatment and reduce drug use, this population is afflicted by numerous conditions including depression. Unfortunately, studies published thus far have reported inconsistent or no difference in response between placebo therapy and antidepressants such as selective serotonin reuptake inhibitors. Objective: To assess the feasibility of Desvenlafaxine (DESV) administration among opioid-dependent subjects and explore its effect on depressive symptoms. Methods: Open-label pilot trial of 8 weeks of DESV 50-100 mg/day in 20 methadone-maintained individuals with comorbid depressive symptoms at the Centre hospitalier de l'Université de Montréal. Significance: This pilot study will lay down the foundation on which a larger multisite clinical trial could be conducted to examine DESV as new treatment for opioid-dependent population with comorbid depression.
详细描述
To assess the feasibility, tolerability and acceptability of 8 weeks of Desvenlafaxine (DESV) administration among opioid-dependent subjects in a methadone-maintenance program, we will collect detailed information on compliance to DESV treatment, side effects, methadone plasma levels, methadone dose changes and QTc measures.
To explore the effects of DESV on depressive symptoms among opioid-dependent subjects on methadone-maintenance treatment. The severity and symptoms of depression will be evaluated by using the MADRS, the HRDS, and the CGI scale.
To explore the effects of DESV on substance use, anxiety, craving, quality of life and suicidal risk.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •DSM-IV-TR criteria for opioid dependence;
- •Subject is on methadone treatment in the substitution program for at least 4 weeks;
- •Subject is aged between 18 and 65 years old;
- •subject meets the DSM-V TR criteria for major depressive episode, according to the study psychiatrist and confirmed by the Mini International Neuropsychiatric Interview (MINI);
- •Subject reports a score of 20 or higher on the MADRS;
- •Subject is eligible for and consents to the study;
- •subject is able to give valid, informed consent;
- •subject is able to speak and read French or English (grade-nine level of language required)
排除标准
- •Unstable medical illness, defined as any medical illness which has not been well-controlled with standard-of-care medications;
- •Severe psychiatric condition (e.g., current acute psychosis, past or current hypomania/mania) based on the MINI;
- •Pregnancy or breastfeeding;
- •Inability to use a medically acceptable form of contraception throughout the study duration. A medically acceptable form of contraception is either: (1) contraceptive pill or intrauterine device or depot hormonal preparation (ring, injection, implant); and/or (2) a barrier method of contraception such as diaphragm, sponge with spermicide or condom;
- •Subject currently takes another antidepressant;
- •Treatment with Desvenlafaxine at any time in the past;
- •Known hypersensitivity to venlafaxine;
- •Subject is undergoing psychotherapies for current depression (support therapy or counseling are allowed);
- •Subject failed to respond to two or more Health-Canada-approved antidepressants during current episode;
- •Unstable Axis-II personality disorder or other Axis-II disorder which has been the primary focus of treatment in the past 3 months, as ascertained by a study psychiatrists;
- •Medical diagnosis of kidney and/or liver failure
研究组 & 干预措施
Desvenlafaxine
- Open-label pilot study
- Desvenlafaxine will be administered during 56 consecutive days
- Desvenlafaxine will be administered in the morning at a 50 mg dose during weeks 1 and 2, and at 50-100 mg doses (based on the study psychiatrist's judgment) during the 6 following weeks.
干预措施: Desvenlafaxine (Drug)
结局指标
主要结局
Tolerability: Systematic Assessment for Treatment Emergent Events (SAFTEE)
时间窗: 8 weeks
Safety and adverse effects with the Systematic Assessment for Treatment Emergent Events (SAFTEE)
次要结局
- Treatment adherence(8 weeks)
- Feasibility: Proportion of persons screened who are eligible and enrolled(Baseline)
- Effect of Desvenlafaxine administration on QT/QTc interval prolongation(4 weeks)
- Methadone dose adjustments(2 - 4 weeks)
- Response to treatment(8 weeks)
- Feasibility: Proportion of scheduled study visits completed and biological samples collected(8 weeks)
- effect of Desvenlafaxine on depressive symptoms(8 weeks)
- Potential for drug interactions between methadone and antidepressants - Effect of Desvenlafaxine on methadone serum level (pharmacokinetic variability)(4 weeks)