NCT02845453

Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation

A Randomized Controlled Trial of Quetiapine for the Treatment of Youth With Co-occurring Substance Use Disorders and Severe Mood Dysregulation

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Boston Medical Center · Academic / Other
• Sex: All
• Age: 15 Years – 24 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Substance Use Disorders
• Bipolar Disorder
• Mood Disorders

Interventions

Type	Name	Description
DRUG	Quetiapine	Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
OTHER	Placebo	Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.

Timeline

• Start date: 2017-01-20
• Primary completion: 2021-04-07
• Completion: 2021-04-07
• First posted: 2016-07-27
• Last updated: 2022-05-11
• Results posted: 2022-04-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study