Treatment With Quetiapine for Youth With Substance Use Disorders and Bipolar Disorder

Description

The purpose of this study is to determine whether quetiapine is effective in the treatment of youth with co-occurring substance use disorders and bipolar disorder.

Study Start Date

September, 01 2016

Estimated Completion Date

January 2020

Interventions

  • Drug: Quetiapine
  • Drug: Placebo

Study ID

Massachusetts General Hospital -- Quetiapine Protocol

Status

Recruiting

Trial ID

NCT02845453

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

56

Sponsor

Massachusetts General Hospital

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. detox 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)
  • Meet DSM-5 criteria for bipolar disorder
  • YMRS ? 20
  • Stable to be treated in outpatient level of care

Exclusion Criteria

  • Current opioid or methamphetamine use disorder
  • Pregnant or breastfeeding
  • Placement in a restricted setting (e.g. detox or residential treatment) for ? 2 weeks out of past 28 days
  • 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
  • Medical or psychiatric condition likely to make participation unsafe as judged by the clinical investigator
  • History of QTc>450 or arrhythmia, family history of malignant arrhythmia, for sudden death
  • AST or ALT greater than three times normal
  • BMI ? 95th percentile
  • Poor command of the English language
  • Current treatment with quetiapine, or an allergy to quetiapine

Gender

All

Ages

15 Years to 24 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (1)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles Rachael Lyons 617-724-5226 rmlyons@mgh.harvard.edu

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