Status:
COMPLETED
Effectiveness of Pramipexole for Treatment-Resistant Depression
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Depression
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study will evaluate the effectiveness of pramipexole (Mirapex) in managing treatment-resistant depression.
Detailed Description
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 wit...
Eligibility Criteria
Inclusion
- Meets diagnostic criteria for major depressive disorder
- Meets criteria for current major depressive episode
- Score of at least 18 on the Montgomery-Asberg Depression Rating Scale (MADRS) at the baseline visit
- Currently being treated with antidepressant monotherapy at an adequate dose for 6 weeks or willing to enter open lead-in treatment
- Agrees to use an effective form of contraception throughout the study
Exclusion
- Pregnant
- At risk for suicide or homicide
- Unstable medical illness (e.g., cardiovascular, liver, kidney, respiratory, endocrine, or neurologic disease, including uncontrolled seizure disorder)
- History of a substance use disorder within 6 months of study enrollment
- History of or current psychotic features
- Currently being treated with typical or atypical antipsychotic medications
- Currently being treated with a medication known to significantly decrease pramipexole clearance (e.g., cimetidine, ranitidine, diltazem, verapamil, quinine or triamterene)
- Clinical or laboratory evidence of untreated hypothyroidism
- History of a 2-week or longer course of pramipexole
- Intolerance of pramipexole at any dose
- Any investigational psychotropic drug use within the last three months
- Level 3 or greater antidepressant resistance as assessed by the ATHF
- Three or more episodes of self-harm in the year prior to study enrollment
- Documented history of poor treatment adherence or frequently missed appointments
- Parkinson's disease
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2008
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT00231959
Start Date
September 1 2003
End Date
April 1 2008
Last Update
April 26 2012
Active Locations (1)
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1
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114