Effectiveness of Pramipexole for Treatment-Resistant Depression

Depression Clinical Trial

Official title:

A Double-Blind Placebo-Controlled Trial of Adjunctive Pramipexole, a Dopamine Receptor Agonist, for Treatment Resistant Major Depressive Episodes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00231959
• Other study ID #: K23MH067060
• Secondary ID: K23MH067060DATR
• Status: Completed
• Phase: Phase 4
• First received: September 30, 2005
• Last updated: April 25, 2012
• Start date: September 2003
• Est. completion date: April 2008

Study information

• Verified date: April 2012
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: April 2008
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Treatment-Resistant

Intervention

Drug:
• Pramipexole (Mirapex)
pramipexole 0.5mg tablets qd and titrated per protocol
• Placebo
sugar pill

Locations

Country	Name	City	State
United States	Depression Clinical and Research Program, Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Score on the Montgomery-Asberg Depression Rating Scale		Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders	Yes
Primary	Clinical Global Impressions (CGI) scale		Measured at Week 8 and monthly for the duration of the 6-month optional continuation phase for responders	Yes