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NCT00254488 · ClinicalTrials.gov registry record · Phase 4
Treatment of Bipolar Mania in Older Adults
A Phase 4 study of Bipolar Disorder and Mania, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Phase 4
- Development phase
- 224
- Enrollment target
- 8
- Study locations
NCT00254488: Completed Phase 4 study of Bipolar Disorder and Mania, sponsored by Weill Medical College of Cornell University.
NCT00254488 is a Phase 4 study of Bipolar Disorder and Mania that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 224 participants, below the 331-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (32% lower). The trial reports 8 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00254488, a Phase 4 study of Bipolar Disorder and Mania, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 224 participants
- Enrollment target
- 8
- Study locations
Study Summary
This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.
Primary Outcome
The Sedation Item score of the UKU (Norwegian for Committee of Clinical Investigations) Side Effect Rating Scale. A higher value indicates greater severity. Range is 0-3 (not present, mild, moderate, or severe).
Conditions Studied
Interventions
- DRUG Lithium (LI)
- DRUG Divalproex (DV)
Study Locations (8)
Pennsylvania
- University of Pennsylvania - Philadelphia
- University of Pittsburgh - Pittsburgh
Mississippi
- Precise Research Centers - Flowood
New York
- Weill Cornell Medical College - White Plains
North Carolina
- Duke University Medical Center - Durham
Ohio
- University Hospitals Case Medical Center - Cleveland
Texas
- Baylor College of Medicine - Houston
Ontario
- Centre for Addiction and Mental Health - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 224 participants |
| Start Date | 2005-11 |
| Est. Completion | 2011-08 |
| Phase | Phase 4 |
What the finished NCT00254488 record still lists
NCT00254488 is an interventional study that assigns participants to a tested intervention. The registered 224 participants enrollment target is mid-sized for trials with a published cap, below the 331-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (32% lower).
The record links to 2 conditions, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Lithium (LI) is the first listed.
NCT00254488 lists 8 locations in 7 states (Pennsylvania, Mississippi, New York).
Frequently Asked Questions
What is clinical trial NCT00254488 about?
NCT00254488 is a clinical study titled "Treatment of Bipolar Mania in Older Adults". This study will compare the benefits and side effects of lithium and divalproex in the treatment of older adults with bipolar mania.
What is the current status of trial NCT00254488?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 224 participants. The study started on 2005-11. Estimated completion is 2011-08.
What conditions does trial NCT00254488 study?
This clinical trial studies the following conditions: Bipolar Disorder, Mania.
What interventions are being tested in trial NCT00254488?
The interventions under investigation include: Lithium (LI) (DRUG), Divalproex (DV) (DRUG).
Who is sponsoring clinical trial NCT00254488?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00254488 being conducted?
This trial has 8 study locations across Mississippi, New York, North Carolina, Ohio, Pennsylvania. 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 NCT00254488's enrollment target sits among peer trials
224 31st of 162 higher than 131 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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