Clinical Trial of Pramipexole in Bipolar Depression
Status:
Completed
Trial end date:
2005-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to examine the safety and effectiveness of the drug pramipexole
given in combination with lithium or divalproex for the short-term treatment of acute
depression in patients with bipolar disorder.
Bipolar disorder is a severe, chronic, and often life-threatening illness. Treatments for
acute unipolar depression have been extensively researched. However, despite the availability
of a wide range of antidepressant drugs, a significant proportion of depressed patients fail
to respond to first-line antidepressant treatment. Novel and improved therapeutics for
bipolar depression are needed. This study will evaluate the antidepressant properties of
pramipexole.
This study will be conducted in three phases. Phase 1 is a 14-day washout period in which
participants will be tapered off all their psychiatric medicines except divalproex or
lithium. Participants will also be asked to adhere to a low caffeine and low monoamine diet.
During Phase 2, participants will be randomly assigned to receive either pramipexole or
placebo (an inactive pill) for 6 weeks. Participants who respond to treatment will be given
either open-label pramipexole or another clinical treatment.
Participants will be screened with a medical history, physical examination, electrocardiogram
(EKG), blood and urine tests, and a psychiatric evaluation. Women of childbearing potential
will have a pregnancy test. Participants will have a physical exam and EKG at study entry and
study completion. Blood will be drawn at various times throughout the study. Pulse and blood
pressure measurements will be taken daily. Weekly interviews will be conducted. Participants
and a control group of healthy volunteers will undergo positron emission tomography (PET) and
magnetic resonance imaging (MRI) scans of the brain.