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NCT00322309 · ClinicalTrials.gov registry record · Phase 2
Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects
A Phase 2 study of Depression and Cocaine Dependence, sponsored by Boston University.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT00322309 is a Phase 2 study of Depression and Cocaine Dependence that has completed, run by Boston University. The registered enrollment target is 24 participants, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00322309, a Phase 2 study of Depression and Cocaine Dependence, has completed, sponsored by Boston University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study is being done to look at the safety of the medication Mirtazapine (Remeron) in people who have cocaine dependence and depression. Hypotheses I. Cocaine usage will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. A greater increase in Clinician Global Impression (CGI) score will be observed in the MG than in the CG. Secondary Hypotheses: I. A greater decrease in Hamilton Rating Scale for Depression (HAM-D) and Hamilton Rating Scale for Anxiety (HAM-A) scores will be observed in the MG than in the CG. II. A greater decrease in HIV risk behaviors will be observed in the MG than in the CG. III. A greater improvement in sleep structure will be observed in the MG than in the CG. IV. The proportion of subjects experiencing severe adverse drug reactions that necessitate termination from the study by one of the study clinicians will not differ between the MG and CG. V. Retention will be greater in MG than in CG.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Mirtazapine
Study Locations (1)
Massachusetts
- Boston University - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2005-09 |
| Est. Completion | 2010-02 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00322309
The ClinicalTrials.gov registry entry for NCT00322309 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 786-participant average among 679 other Depression trials with a reported enrollment target (97% lower). The listed sponsor is Boston University, which has 185 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00322309 reports 1 study location spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT00322309 about?
NCT00322309 is a clinical study titled "Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects". This research study is being done to look at the safety of the medication Mirtazapine (Remeron) in people who have cocaine dependence and depression. Hypotheses I. Cocaine usage will be less in the mirtazapine treatment group (MG) than in the control group (CG). II. A greater increase in Clinician G...
What is the current status of trial NCT00322309?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2005-09. Estimated completion is 2010-02.
What conditions does trial NCT00322309 study?
This clinical trial studies the following conditions: Depression, Cocaine Dependence.
What interventions are being tested in trial NCT00322309?
The interventions under investigation include: Placebo (OTHER), Mirtazapine (DRUG).
Who is sponsoring clinical trial NCT00322309?
This trial is sponsored by Boston University, which has 185 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00322309 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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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.