Effectiveness of Pramipexole for Treatment-Resistant Depression
This study will evaluate the effectiveness of pramipexole (Mirapex) in managing treatment-resistant depression.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Double-Blind Placebo-Controlled Trial of Adjunctive Pramipexole, a Dopamine Receptor Agonist, for Treatment Resistant Major Depressive Episodes|
- Score on the Montgomery-Asberg Depression Rating Scale [ Time Frame: Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders ] [ Designated as safety issue: Yes ]
- Clinical Global Impressions (CGI) scale [ Time Frame: Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2003|
|Study Completion Date:||April 2008|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Placebo Comparator: Sugar pill
Drug: Pramipexole (Mirapex)
pramipexole 0.5mg tablets qd and titrated per protocol
Depression is a serious medical illness, for which various types of treatment have been developed. Both medications and therapies have proven effective in treating depression. However, some people with depression do not benefit from these treatments. New medications are needed for treating depression in those who have not responded to commonly used antidepressants. Pramipexole (Mirapex) is most often used for the treatment of Parkinson's disease, but has been reported to have antidepressant effects as well. This study will evaluate the effectiveness of pramipexole in treating depression in individuals that have not responded to other medications.
Participants in this double blind study will be randomly assigned to receive either pramipexole or placebo, in addition to their current medications, for 8 weeks. Treatment response will be assessed at the end of this phase by measuring symptoms of depression. At this time, those individuals who have responded to treatment will have the option to continue in a 6-month follow-up study. Participants will be seen monthly throughout the 6 months to assess treatment response. Participants who do not exhibit a response to treatment will be tapered off the medication. All participants will receive 3 months of follow-up care, regardless of their response to the medication.
|United States, Massachusetts|
|Depression Clinical and Research Program, Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Roy Perlis, MD||Massachusetts General Hospital|