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NCT02185131 · ClinicalTrials.gov registry record · Phase 2
Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.
A Phase 2 study of Major Depressive Disorder and Alcohol Use Disorder, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 16
- Enrollment target
- 1
- Study location
NCT02185131: Completed Phase 2 study of Major Depressive Disorder and Alcohol Use Disorder, sponsored by University of Pittsburgh.
NCT02185131 is a Phase 2 study of Major Depressive Disorder and Alcohol Use Disorder that has completed, run by University of Pittsburgh. The registered enrollment target is 16 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02185131, a Phase 2 study of Major Depressive Disorder and Alcohol Use Disorder, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 16 participants
- Enrollment target
- 1
- Study location
Study Summary
Mirtazapine is a non-SSRI (selective serotonin reuptake inhibitor) medication with a unique structure and mechanism of action. Recent study results suggest that mirtazapine may be more effective and faster acting than other antidepressants. Levels of alcohol use have been shown to be associated with levels of depressive symptoms among comorbid populations. Our own recent open label pilot study suggested robust within-group efficacy for mirtazapine for decreasing both the drinking and the depressive symptoms of persons with co-occurring alcohol dependence/major depressive disorder (AD/MDD). However, no placebo control group was employed in that study, so between-group efficacy versus placebo could not be assessed. The current grant submission proposes to conduct a first double-blind, placebo-controlled study to evaluate the efficacy of mirtazapine versus placebo for decreasing the alcohol use and depressive symptoms of persons with comorbid AD/MDD. If the results of this proposed double-blind pilot trial are promising, then the effect sizes found in this proposed study will be used to help design an adequately-powered R01 treatment trial to definitively test the efficacy of mirtazapine in this comorbid population.
Primary Outcome
Level of drinking, as indicated by the number of drinks per day as recorded on the Timeline Follow-Back calendar.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mirtazapine
Study Locations (1)
Pennsylvania
- Western Psychiatric Institute and Clinic - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-07 |
| Phase | Phase 2 |
What the finished NCT02185131 record still lists
NCT02185131 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 16 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower).
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02185131 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02185131 about?
NCT02185131 is a clinical study titled "Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.". Mirtazapine is a non-SSRI (selective serotonin reuptake inhibitor) medication with a unique structure and mechanism of action. Recent study results suggest that mirtazapine may be more effective and faster acting than other antidepressants. Levels of alcohol use have been shown to be associated with...
What is the current status of trial NCT02185131?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 16 participants. The study started on 2013-09. Estimated completion is 2016-07.
What conditions does trial NCT02185131 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Alcohol Use Disorder.
What interventions are being tested in trial NCT02185131?
The interventions under investigation include: Placebo (DRUG), Mirtazapine (DRUG).
Who is sponsoring clinical trial NCT02185131?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02185131 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive 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 NCT02185131's enrollment target sits among peer trials
16 257th of 282 higher than 23 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive 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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