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



Status:Recruiting
Conditions:Psychiatric, Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:15 - 24
Updated:7/13/2018
Start Date:September 2016
End Date:January 2020
Contact:Rachael Lyons, BS
Email:rmlyons@mgh.harvard.edu
Phone:617-724-5226

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

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


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)

- 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 NOS

- 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
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-5226
?
mi
from
Boston, MA
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