Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation (NCT02845453) | Clinical Trial Compass
CompletedPhase 4
Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
United States24 participantsStarted 2017-01-20
Plain-language summary
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.
Who can participate
Age range
15 Years – 24 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Timeline Followback of Substance Use (TLFB)