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NCT02397837 · ClinicalTrials.gov registry record · Phase 4
Targeting Cognition in Bipolar Disorder With Pramipexole
A Phase 4 study of Bipolar Disorder, sponsored by Brigham and Women's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 103
- Enrollment target
- 3
- Study locations
NCT02397837: Completed Phase 4 study of Bipolar Disorder, sponsored by Brigham and Women's Hospital.
NCT02397837 is a Phase 4 study of Bipolar Disorder that has completed, run by Brigham and Women's Hospital. The registered enrollment target is 103 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (69% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02397837, a Phase 4 study of Bipolar Disorder, has completed, sponsored by Brigham and Women's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 103 participants
- Enrollment target
- 3
- Study locations
Study Summary
Converging evidence suggests that patients with bipolar disorder suffer from deficits in neurocognitive functioning that persist, despite remission of acute affective symptoms. These impairments contribute directly to functional disability, highlighting the need for interventions above and beyond standard treatments in order to achieve a full inter-episode recovery. The current study aims to investigate the safety and efficacy of a dopamine agonist (pramipexole), on these persistent cognitive abnormalities in euthymic bipolar patients using a placebo-controlled, adjunctive, 12-week trial design.
Primary Outcome
MATRICS Consensus Cognitive Battery (MCCB) as measure of Neurocognitive/Functional Measures is a standardized battery designed to measure cognitive functioning in people with schizophrenia. The MCCB is represented as a composite T score. This T-score scale has a mean of 50 and a standard deviation of 10, where higher scores reflect better performance.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Pramipexole
Study Locations (3)
New York
- The Zucker Hillside Hospital - Glen Oaks
- Icahn School of Medicine at Mount Sinai - New York
Massachusetts
- Brigham and Women's Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 103 participants |
| Start Date | 2014-10 |
| Est. Completion | 2018-07-26 |
| Phase | Phase 4 |
What the finished NCT02397837 record still lists
NCT02397837 is an interventional study that assigns participants to a tested intervention. The registered 103 participants enrollment target is mid-sized for trials with a published cap, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (69% lower).
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02397837 reports a single indexed study location in New York, Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02397837 about?
NCT02397837 is a clinical study titled "Targeting Cognition in Bipolar Disorder With Pramipexole". Converging evidence suggests that patients with bipolar disorder suffer from deficits in neurocognitive functioning that persist, despite remission of acute affective symptoms. These impairments contribute directly to functional disability, highlighting the need for interventions above and beyond st...
What is the current status of trial NCT02397837?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 103 participants. The study started on 2014-10. Estimated completion is 2018-07-26.
What conditions does trial NCT02397837 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT02397837?
The interventions under investigation include: Placebo (DRUG), Pramipexole (DRUG).
Who is sponsoring clinical trial NCT02397837?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02397837 being conducted?
This trial has 3 study locations across Massachusetts, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02397837's enrollment target sits among peer trials
103 65th of 162 higher than 98 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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