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NCT00025792 · ClinicalTrials.gov registry record · Phase 2
Clinical Trial of Pramipexole in Bipolar Depression
A Phase 2 study, sponsored by National Institute of Mental Health (NIMH).
- Completed
- Registry status
- Phase 2
- Development phase
- 200
- Enrollment target
NCT00025792 is a Phase 2 study that has completed, run by National Institute of Mental Health (NIMH). The registered enrollment target is 200 participants.
The verdict
NCT00025792, a Phase 2 study, has completed, sponsored by National Institute of Mental Health (NIMH).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 200 participants
- Enrollment target
Study 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.
Interventions
- DRUG Pramipexole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2001-10 |
| Est. Completion | 2005-11 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00025792
The ClinicalTrials.gov registry entry for NCT00025792 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Mental Health (NIMH), which has 343 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pramipexole is the first listed.
NCT00025792 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00025792 about?
NCT00025792 is a clinical study titled "Clinical Trial of Pramipexole in Bipolar Depression". 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....
What is the current status of trial NCT00025792?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 200 participants. The study started on 2001-10. Estimated completion is 2005-11.
What interventions are being tested in trial NCT00025792?
The interventions under investigation include: Pramipexole (DRUG).
Who is sponsoring clinical trial NCT00025792?
This trial is sponsored by National Institute of Mental Health (NIMH), which has 343 total clinical trials registered on ClinicalTrials.gov.
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