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NCT02845453 · ClinicalTrials.gov registry record · Phase 4
Treatment With Quetiapine for Youth With Substance Use Disorders and Severe Mood Dysregulation
A Phase 4 study of Bipolar Disorder and Substance Use Disorders, sponsored by Boston Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT02845453: Completed Phase 4 study of Bipolar Disorder and Substance Use Disorders, sponsored by Boston Medical Center.
NCT02845453 is a Phase 4 study of Bipolar Disorder and Substance Use Disorders that has completed, run by Boston Medical Center. The registered enrollment target is 24 participants, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02845453, a Phase 4 study of Bipolar Disorder and Substance Use Disorders, has completed, sponsored by Boston Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Quetiapine
Study Locations (1)
Massachusetts
- Boston Medical Center - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-01-20 |
| Est. Completion | 2021-04-07 |
| Phase | Phase 4 |
What the finished NCT02845453 record still lists
NCT02845453 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 333-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (93% lower).
The record links to 3 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02845453 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02845453 about?
NCT02845453 is a clinical study titled "Treatment With Quetiapine for Youth With 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 o...
What is the current status of trial NCT02845453?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 24 participants. The study started on 2017-01-20. Estimated completion is 2021-04-07.
What conditions does trial NCT02845453 study?
This clinical trial studies the following conditions: Bipolar Disorder, Substance Use Disorders, Mood Disorders.
What interventions are being tested in trial NCT02845453?
The interventions under investigation include: Placebo (OTHER), Quetiapine (DRUG).
Who is sponsoring clinical trial NCT02845453?
This trial is sponsored by Boston Medical Center, which has 253 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02845453 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02845453's enrollment target sits among peer trials
24 151st of 162 higher than 12 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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