A Randomized Controlled Trial of Quetiapine for the Treatment of Youth With Co-occurring Substance Use Disorders and Severe Mood Dysregulation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Timeline Followback of Substance Use (TLFB)
研究概览
简要总结
This study proposes to use quetiapine as an adjunct treatment to treatment as usual to improve both substance use disorder (SUD) and mood symptoms in youth with SUD and severe mood dysregulation (SMD). This is a randomized, double blind placebo controlled parallel design study. Youth with symptoms of mood dysregulation and active substance use that meets criteria for a SUD will be randomized to adjunct treatment with quetiapine or placebo. The investigators hypothesize that treatment with quetiapine will lead to a reduction in substance use, improvement in mood, and lead to greater engagement in outpatient treatment.
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
- 15 Years 至 24 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 15 to 24
- •Meet DSM-5 criteria for a substance use disorder
- •Substance use ≥ 14 days of past 28 days (i.e. use ≥ 50% of days in the past 28 days)
- •If subject in restricted setting/care (e.g. inpatient detox unit or residential treatment) for ≤ 2 weeks, then use ≥ 50% of days while outside of restricted setting (e.g. 7 days of substance use out of 14 days in unrestricted setting)
- •Subjects need to have been in an unrestricted setting for at least 2 weeks prior to screening
- •Meets DSM-5 criteria for bipolar disorder or disruptive mood dysregulation disorder or DSM IV criteria for mood disorder not otherwise specified
- •Symptoms of SMD: Youth Self Report (YSR) or Adult Self Report (ASR) AAA ≥180
- •Stable to be treated in outpatient level of care
排除标准
- •Current methamphetamine use disorder
- •Current unstable opioid use disorder (i.e. < 3 months on medication assisted treatment for an opioid use disorder)
- •Pregnant or breastfeeding
- •Placement in a restricted setting (e.g. detox or residential treatment) for ≥ 2 weeks out of past 28 days prior to screening visit, or placement in a restricted setting at anytime during study participation
- •Unwilling or unable to use effective birth control
- •Unwilling or unable to sign release of information for the treatment program providing behavioral treatment
- •For participants >17 years-unable or unwilling to identify emergency contact
研究组 & 干预措施
Quetiapine
Quetiapine
干预措施: Quetiapine (Drug)
Placebo
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Change in Timeline Followback of Substance Use (TLFB)
时间窗: baseline, 8 weeks
The TLFB is used to quantify self-reported drug of choice use during the past month. Counts the number of days with substance use in the past 28 days.
Change in Symptoms of Mania
时间窗: baseline, 8 weeks
Symptoms of mania will be assessed using the Young Mania Rating Scale (YMRS). The YMRS consists of 11 items rated on a scale. Each item is composed of 5 explicitly defined levels of severity. Severity ratings for 7 items are scored on a scale of 0 -4. The remaining 4 items are double weighted to account for poor cooperation of client when unwell and are scored on a scale of 0 - 8. Item ratings are sum to produce a total YMRS score between 0 -60. Higher scores on the YMRS indicate greater symptoms of mania.
次要结局
- Change in the Number of Negative Urine Toxicology Specimens(baseline, 8 weeks)
- Change in Symptoms of Depression(baseline, 8 weeks)
- Change in Craving for the Substance That the Participant Identifies as Most Problematic(baseline, 8 weeks)