Effectiveness of Pramipexole for Treatment-Resistant Depression

Completed · Phase 4 · Has a placebo group

Conditions studied: Depression

In brief

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

Key facts

Study ID

NCT00231959

Run by

Massachusetts General Hospital

People needed

65

Starts

2003-09-01

Expected to finish

2008-04-01

Last updated by the study team

2012-04-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Depression Clinical and Research Program, Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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