- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02845453
Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
April 19, 2022 updated by: Boston Medical Center
A Randomized Controlled Trial of Quetiapine for the Treatment of Youth With Co-occurring Substance Use Disorders and Severe Mood Dysregulation
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
24
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Boston, Massachusetts, United States, 02118
- Boston Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years to 24 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
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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.
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Experimental: Quetiapine
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Timeline Followback of Substance Use (TLFB)
Time Frame: baseline, 8 weeks
|
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
Time Frame: baseline, 8 weeks
|
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.
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baseline, 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Number of Negative Urine Toxicology Specimens
Time Frame: baseline, 8 weeks
|
Urine toxicology specimens for the participant's drug of choice assessed as positive or negative.
For each participant, the proportion of urine toxicology specimens that are negative over the course of the trial are calculated as the number of negative specimens divided by the total number of specimens collected from week 1 until study endpoint.
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baseline, 8 weeks
|
Change in Craving for the Substance That the Participant Identifies as Most Problematic
Time Frame: baseline, 8 weeks
|
Craving will be measured by the Weiss Craving Scale.
This scale consists of 3 items rated on a scale from 0 (no desire/likelihood of use) to 9 (strong desire/likelihood of use).
The total Weiss Craving Scale score ranges from 0 to 27.
Higher scores on the Weiss Craving Scale indicate greater cravings for a substance.
|
baseline, 8 weeks
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Change in Symptoms of Depression
Time Frame: baseline, 8 weeks
|
Symptoms of depression will be assessed using the Beck Depression Inventory II (BDI-II) scale.
The BDI-II consists of 21 items rated on a scale from 0 (symptoms not present) to 3 (symptoms extremely severe).
Total scores on the BDI-II range from 0 to 63.
Higher scores indicate greater symptoms of depression.
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baseline, 8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Amy Yule, M.D., Boston Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 20, 2017
Primary Completion (Actual)
April 7, 2021
Study Completion (Actual)
April 7, 2021
Study Registration Dates
First Submitted
July 14, 2016
First Submitted That Met QC Criteria
July 26, 2016
First Posted (Estimate)
July 27, 2016
Study Record Updates
Last Update Posted (Actual)
May 11, 2022
Last Update Submitted That Met QC Criteria
April 19, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Bipolar and Related Disorders
- Substance-Related Disorders
- Disease
- Bipolar Disorder
- Mood Disorders
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- H-39577
- 5K12DA000357-17 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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