Phase 4
N=24
Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
Substance Use Disorders · Bipolar Disorder · Mood Disorders
Bottom Line
View on ClinicalTrials.gov: NCT02845453 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Apr 2022
Primary outcome: Primary: Change in Timeline Followback of Substance Use (TLFB) — 2.3; 3.3 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Quetiapine (Drug); Placebo (Other)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- All
- Sponsor
- Boston Medical Center
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Timeline Followback of Substance Use (TLFB) |
2.3; 3.3 | — |
| PRIMARY Change in Symptoms of Mania |
-8.8; -0.4 | — |
| SECONDARY Change in the Number of Negative Urine Toxicology Specimens |
0; 0 | — |
| SECONDARY Change in Craving for the Substance That the Participant Identifies as Most Problematic |
-1.8; 0.4 | — |
| SECONDARY Change in Symptoms of Depression |
-9.1; -6.2 | — |
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.
Eligibility Criteria
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. 17 years-unable or unwilling to identify emergency contact
Data sourced from ClinicalTrials.gov (NCT02845453). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.