Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02646449 · ClinicalTrials.gov registry record · Phase 2
Treatment of Young Adults With Comorbid AUD/MDD: A Pilot Medication Trial
A Phase 2 study of Major Depressive Disorder and Alcohol Use Disorder, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 2
- Development phase
- 11
- Enrollment target
- 1
- Study location
NCT02646449 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 11 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02646449, 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
- 11 participants
- Enrollment target
- 1
- Study location
Study Summary
Recent reports have shown that alcohol misuse is a particularly serious problem among the 18 to 25 year old age group. Previous medication trials with SSRI antidepressants among young adults with co-occurring depressive disorders, including our own recent trials with SSRI medications, have produced disappointing results, especially for decreasing the level of alcohol consumption. Mirtazapine is a non-SSRI medication with a unique structure and mechanism of action. Recent study results suggest that mirtazapine is more effective than other antidepressants for treating non-comorbid depression. A few recent studies with mirtazapine have been conducted among subjects with comorbid AUD/MDD, and those studies have demonstrated efficacy for mirtazapine for decreasing the depressive symptoms and the alcohol craving of subjects with comorbid AUD/MDD. However, those studies did not measure level of alcohol consumption, so it is unclear whether mirtazapine decreases the level of alcohol use of that comorbid population. The results of our own very recent open label pilot study suggest robust within-group efficacy for mirtazapine for decreasing both the level of alcohol use and the depressive symptoms of comorbid subjects. However, that pilot study did not include a placebo control group, so the efficacy of mirtazapine versus placebo for decreasing the level of alcohol use among persons with comorbid AUD/MDD remains unclear. This grant submission proposes to conduct a first double-blind, placebo-controlled pilot study to provide a preliminary assessment of the efficacy of mirtazapine versus placebo for decreasing both the alcohol use and depressive symptoms of young adults with comorbid AUD/MDD. If results (effect sizes) from the proposed study are found to be promising concerning outcome differences between the mirtazapine and placebo groups, then we will use those findings to apply for an R01 study to definitively assess the efficacy of mirtazapine for treating young adults wit
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Mirtazapine
Study Locations (1)
Pennsylvania
- Western Psychiatric Institute and Clinic - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2015-06 |
| Est. Completion | 2016-12 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02646449
The ClinicalTrials.gov registry entry for NCT02646449 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 11 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 (97% 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.
NCT02646449 reports 1 study location spanning 1 distinct geographic area - top geographies include Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT02646449 about?
NCT02646449 is a clinical study titled "Treatment of Young Adults With Comorbid AUD/MDD: A Pilot Medication Trial". Recent reports have shown that alcohol misuse is a particularly serious problem among the 18 to 25 year old age group. Previous medication trials with SSRI antidepressants among young adults with co-occurring depressive disorders, including our own recent trials with SSRI medications, have produced ...
What is the current status of trial NCT02646449?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 11 participants. The study started on 2015-06. Estimated completion is 2016-12.
What conditions does trial NCT02646449 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Alcohol Use Disorder.
What interventions are being tested in trial NCT02646449?
The interventions under investigation include: Placebo (DRUG), Mirtazapine (DRUG).
Who is sponsoring clinical trial NCT02646449?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02646449 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.
-
A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder
RECRUITING · Phase 2
-
A Study to Assess Change in Disease Activity and Adverse Events of Oral Icalcaprant in Adult Participants With Major Depressive Disorder
RECRUITING · Phase 2
-
Study of ALTO-300 in MDD
RECRUITING · Phase 2
-
Regulation of Affect and Physiology in Depression
RECRUITING · Phase 2
-
Sodium-Glucose Cotransporter-2 Inhibitor (SGLT2) in Major Depressive Disorder (MDD)
RECRUITING · Phase 2
-
A Study of the Efficacy and Safety of SP-624 in the Treatment of Adults With Major Depressive Disorder
RECRUITING · Phase 2
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.