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

NCT ID: NCT02845453

Last Updated: 2022-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-20
• Study Completion Date: 2021-04-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Quetiapine

Quetiapine

Group Type: EXPERIMENTAL

Quetiapine

Intervention Type: DRUG

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.

Placebo

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DRUG

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.

Intervention Type: OTHER

Other Intervention Names

Seroquel

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. < 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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 24 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Boston Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Yule, M.D.

Role: STUDY_CHAIR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5K12DA000357-17

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H-39577

Identifier Type: -

Identifier Source: org_study_id