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

NCT02845453 | Completed Phase 4 Results DMC FDA Drug

• 2 other identifiers: H-395775K12DA000357-17
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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

Keywords

youth; adolescent; young adult; substance use disorder; bipolar disorder; quetiapine; mood dysregulation

Outcome Measures

Primary Outcomes (2)

• Change in Timeline Followback of Substance Use (TLFB)

  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.

  baseline, 8 weeks

• Change in Symptoms of Mania

  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.

  baseline, 8 weeks

Secondary Outcomes (3)

• Change in the Number of Negative Urine Toxicology Specimens

  baseline, 8 weeks

• Change in Craving for the Substance That the Participant Identifies as Most Problematic

  baseline, 8 weeks

• Change in Symptoms of Depression

  baseline, 8 weeks

Study Arms (2)

Quetiapine

EXPERIMENTAL

Quetiapine

Drug: Quetiapine

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Quetiapine 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.

Also known as: Seroquel

Quetiapine

Placebo 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.

Placebo

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Medical Center: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders; Bipolar Disorder; Mood Disorders

Interventions

Quetiapine Fumarate

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders; Bipolar and Related Disorders

Intervention Hierarchy (Ancestors)

Dibenzothiazepines; Thiazepines; Thiepins; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Amy Yule, MD
• Organization: Boston Medical Center

amy.yule@bmc.org

617-414-1936

Study Officials

• Amy Yule, M.D.

  Boston Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2016
• First Posted: July 27, 2016
• Study Start: January 20, 2017
• Primary Completion: April 7, 2021
• Study Completion: April 7, 2021
• Last Updated: May 11, 2022
• Results First Posted: April 18, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)