Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects
Status:
Completed
Trial end date:
2010-02-01
Target enrollment:
Participant gender:
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.