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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02185131
The ClinicalTrials.gov registry entry for NCT02185131 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 16 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (96% lower). The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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