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NCT02918370 · ClinicalTrials.gov registry record · Phase 3
Aripiprazole for Bipolar Disorder and Alcohol Use Disorder
A Phase 3 study of Bipolar Disorder and Alcoholism, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 75
- Enrollment target
- 1
- Study location
NCT02918370: Completed Phase 3 study of Bipolar Disorder and Alcoholism, sponsored by University of Texas Southwestern Medical Center.
NCT02918370 is a Phase 3 study of Bipolar Disorder and Alcoholism that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 75 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (77% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02918370, a Phase 3 study of Bipolar Disorder and Alcoholism, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 75 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigators will conduct a 12-week, randomized, double-blind, parallel-group, placebo-controlled study of aripiprazole in 132 persons with Alcohol Use Disorder (AUD) and bipolar I or II disorder, currently depressed or mixed phase. Primary Aim will be to assess change in alcohol use by the Timeline Followback (TLFB) method. Secondary Aim will include change in alcohol craving using the Penn Alcohol Craving Scale (PACS). Changes in psychiatric symptoms (mania/hypomania and depression) and predictors of response will be assessed. Participants with ≥ 1 drinking day at week 12 will be enrolled in a 4-week extension phase with an upward titration to 30 mg/day for those in the active treatment group. The placebo group will remain on placebo. Subjects will be discontinued from the study if any of the following conditions occurs: change in diagnosis to other than bipolar I or II disorder and AUD, development of active suicidal or homicidal ideation with plan and intent, worsening in mood symptoms, that in the opinion of the investigators requires discontinuation, pregnancy, development of severe or life-threatening medical condition, involuntary psychiatric hospitalization or incarceration, significant alcohol withdrawal (e.g. delirium tremens) based on clinical judgment (increases in Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar) scores will initiate a careful clinical assessment of possible worsening of withdrawal symptoms), or cocaine or amphetamine-positive urine drug screen during the study.
Primary Outcome
The Timeline Followback (TLFB) is used to assess recent alcohol use (and if present, other substance use). The calculation is based on the change between baseline and week 12.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Aripiprazole
Study Locations (1)
Texas
- UT Southwestern - Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2016-11 |
| Est. Completion | 2023-06-30 |
| Phase | Phase 3 |
What the finished NCT02918370 record still lists
NCT02918370 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (77% 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.
NCT02918370 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT02918370 about?
NCT02918370 is a clinical study titled "Aripiprazole for Bipolar Disorder and Alcohol Use Disorder". The investigators will conduct a 12-week, randomized, double-blind, parallel-group, placebo-controlled study of aripiprazole in 132 persons with Alcohol Use Disorder (AUD) and bipolar I or II disorder, currently depressed or mixed phase. Primary Aim will be to assess change in alcohol use by the Tim...
What is the current status of trial NCT02918370?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 75 participants. The study started on 2016-11. Estimated completion is 2023-06-30.
What conditions does trial NCT02918370 study?
This clinical trial studies the following conditions: Bipolar Disorder, Alcoholism, Alcohol Abuse.
What interventions are being tested in trial NCT02918370?
The interventions under investigation include: Placebo (DRUG), Aripiprazole (DRUG).
Who is sponsoring clinical trial NCT02918370?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02918370 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT02918370's enrollment target sits among peer trials
75 80th of 162 higher than 81 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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