Effectiveness of Pramipexole for Treatment-Resistant Depression

• Status: Completed
• Trial end date: 2008-04-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the effectiveness of pramipexole (Mirapex) in managing treatment-resistant depression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Massachusetts General Hospital
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Pramipexole

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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