Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
Condition: Substance Use Disorders; Bipolar Disorder; Mood Disorders
MeSH terms: Substance-Related Disorders; Bipolar Disorder; Mood Disorders
Intervention: Quetiapine; Placebo
Intervention description: 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.; 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 MeSH terms: Quetiapine Fumarate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 24.0
Sex: All
Minimum age: 15 Years
Maximum age: 24 Years
Healthy volunteers: No
Keywords: youth; adolescent; young adult; substance use disorder; bipolar disorder; quetiapine; mood dysregulation

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. < 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