NCT00893841

Bipolar Study of Seroquel XR With Pramipexole Dihydrochloride

A Randomized, Double-Blind, Placebo Controlled Exploratory Study of Augmentation of Seroquel XR With Pramipexole Dihydrochloride for Bipolar Depression

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Dr. D McIntosh & Dr. K Kjernisted Clinical Research Inc. · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the use of pramipexole dihydrochloride and quetiapine (Seroquel) XR as combination therapy for bipolar depression. The proposed benefit of the combination therapy investigated in this study is improved treatment of bipolar depression.

Detailed description

Quetiapine is a first-line option in Canadian guidelines for the treatment of bipolar depression; however, there is room for improvement as the remission rate is approximately 50% and the response rate is approximately 60%. Pramipexole, which is currently used to treat Parkinson's disease and restless legs syndrome, is reported to have antidepressant effects in patients with unipolar or bipolar depression. There are no other clinical studies to evaluate the efficacy of pramipexole combined with an atypical antipsychotic, such as quetiapine XR, in the treatment of bipolar depression. This study is a multicentre, randomized, double-blind and placebo-controlled exploratory study in which patients will receive one of three treatment arms for a treatment period of 16 weeks: quetiapine XR plus placebo, quetiapine XR plus 0.25mg pramipexole, or quetiapine XR plus 0.50mg pramipexole.

Conditions

• Bipolar Depression

Interventions

Type	Name	Description
DRUG	quetiapine (Seroquel) XR	tablets and caplets, take with liquid before bedtime
DRUG	quetiapine (Seroquel) XR	tablets, take with liquid before bedtime
DRUG	placebo	placebo
DRUG	pramipexole dihydrochloride	tablets and caplets, take with liquid before bedtime

Timeline

• Start date: 2009-02-01
• Primary completion: 2013-01-01
• Completion: 2013-01-01
• First posted: 2009-05-06
• Last updated: 2013-02-04

Locations

9 sites across 2 countries: United States, Canada