Effectiveness of Pramipexole for Treatment-Resistant Depression
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
- 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 |
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| United States, Massachusetts | |
| Depression Clinical and Research Program, Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | Roy Perlis, MD | Massachusetts General Hospital |
More Information
No publications provided
| 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 Behavioral Symptoms Mood Disorders Mental Disorders Pramipexol Dopamine Agonists Antioxidants Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Protective Agents Physiological Effects of Drugs Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Dopamine Agents Neurotransmitter Agents |
ClinicalTrials.gov processed this record on May 23, 2013