Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00322309|
Recruitment Status : Completed
First Posted : May 5, 2006
Results First Posted : April 20, 2017
Last Update Posted : April 20, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cocaine Dependence Depression||Other: Placebo Drug: Mirtazapine||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Efficacy of Mirtazapine in Depressed Cocaine Dependent Subjects|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||July 2009|
|Actual Study Completion Date :||February 2010|
Mirtazapine administration as follows:
Days 1-4 15mg of mirtazapine daily Days 5-9 30mg of mirtazapine daily Days 10-78 45mg of mirtazapine daily Days 79-81 30mg of mirtazapine daily Days 82-84 15mg of mirtazapine daily
Days 1-4 15mg Days 5-9 30 mg Days 10-78 45mg Days 79-81 30mg Days 82-84 15mg
Other Name: Remeron
Placebo Comparator: Placebo- Sugar pill
Matched Placebo given daily days 1-84
Placebo for days 1-4 Placebo for days 5-9 Placebo for days10-78 Placebo for days 79-81 Placebo for days 82-84
- Ln Benzoylecgonine Concentration [ Time Frame: Week 11 ]
- The Clinical Global Impression Observer (CGI-O)Comparison for Week 11 [ Time Frame: Week 11 ]Clinician's overall assessment of the subjects global functioning including the severity of the subject's cocaine use, cocaine seeking, use of other drugs, psychiatric symptoms, medical problems, maladaptive family/social coping, and coping with issues related to employment, housing, and legal issues. Totals range between 7 (for none) to 56 for most severe.
- Hamilton Depression Rating Scale [ Time Frame: Week 11 ]Subjects are assessed on 24 characteristics of depressive disorders. Scale scores may range from 0 for no depressive symptoms to 75.
- Pill Count [ Time Frame: Weeks 1 to 11 ]Percentage of medication capsules administered based on the ratio of the number of capsules administered to the total number dispensed for entire period during which subjects were in treatment.
- Percent Urines Positive for Riboflavin [ Time Frame: Weeks 1-11 ]This measure of adherence was determined by finding the percent of total urines examined that were positive for riboflavin, which had been added to each medication tablet.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322309
|United States, Massachusetts|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Maryam Afshar, MD||Boston University|