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Trial record 1 of 1 for:    NCT00231959
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Effectiveness of Pramipexole for Treatment-Resistant Depression

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ClinicalTrials.gov Identifier: NCT00231959
Recruitment Status : Completed
First Posted : October 4, 2005
Last Update Posted : April 26, 2012
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Roy Perlis, Massachusetts General Hospital

Study Description
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Brief Summary:
This study will evaluate the effectiveness of pramipexole (Mirapex) in managing treatment-resistant depression.

Condition or disease Intervention/treatment Phase
Depression Drug: Pramipexole (Mirapex) Drug: Placebo Phase 4

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : September 2003
Actual Primary Completion Date : September 2007
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Sugar pill
Placebo
 Drug: Placebo
sugar pill
Experimental: Pramipexole Drug: Pramipexole (Mirapex)
pramipexole 0.5mg tablets qd and titrated per protocol


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]
  2. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00231959


Locations
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United States, Massachusetts
Depression Clinical and Research Program, Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Roy Perlis, MD Massachusetts General Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Roy Perlis, Director, Center for Experimental Drugs and Diagnostics, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00231959    
Other Study ID Numbers: K23MH067060 ( U.S. NIH Grant/Contract )
K23MH067060 ( U.S. NIH Grant/Contract )
DATR AK-TNGP1
First Posted: October 4, 2005    Key Record Dates
Last Update Posted: April 26, 2012
Last Verified: April 2012
Keywords provided by Roy Perlis, Massachusetts General Hospital:
Depression, Treatment-Resistant
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
 Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents