Effectiveness of Pramipexole for Treatment-Resistant Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Roy Perlis, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00231959
First received: September 30, 2005
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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


Condition Intervention Phase
Depression
Drug: Pramipexole (Mirapex)
Drug: Placebo
Phase 4

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • 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 ]

Enrollment: 65
Study Start Date: September 2003
Study Completion Date: April 2008
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Sugar pill
Placebo
Drug: Placebo
sugar pill
Experimental: Pramipexole Drug: Pramipexole (Mirapex)
pramipexole 0.5mg tablets qd and titrated per protocol

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00231959

Locations
United States, Massachusetts
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Roy Perlis, MD Massachusetts General Hospital
  More Information

No publications provided by Massachusetts General Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Roy Perlis, Director, Center for Experimental Drugs and Diagnostics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00231959     History of Changes
Other Study ID Numbers: K23 MH67060, K23MH067060, DATR AK-TNGP1
Study First Received: September 30, 2005
Last Updated: April 25, 2012
Health Authority: United States: Federal Government

Keywords provided by Massachusetts General Hospital:
Depression, Treatment-Resistant

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pramipexole
Anti-Dyskinesia Agents
Antioxidants
Antiparkinson Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014