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NCT00761761 · ClinicalTrials.gov registry record · Phase 3
Sensoril(Ashwaganhda)for Bipolar Disorder
A Phase 3 study of Bipolar I Disorder and Bipolar II Disorder, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 3
- Development phase
- 60
- Enrollment target
- 2
- Study locations
NCT00761761: Completed Phase 3 study of Bipolar I Disorder and Bipolar II Disorder, sponsored by University of Pittsburgh.
NCT00761761 is a Phase 3 study of Bipolar I Disorder and Bipolar II Disorder that has completed, run by University of Pittsburgh. The registered enrollment target is 60 participants, below the 328-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00761761, a Phase 3 study of Bipolar I Disorder and Bipolar II Disorder, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 60 participants
- Enrollment target
- 2
- Study locations
Study Summary
The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance cognitive abilities (specifically measures of attention, executive function, working memory, and visuospatial ability) in persons with bipolar disorder. Secondarily, the investigators hypothesize there will be secondary improvements in residual mood/anxiety symptoms, and metabolic indices, if impaired (fasting blood glucose and lipids). The investigators aim to test these hypotheses by conducting a randomized, placebo controlled, add on treatment trial of Sensoril® (added to existing mood stabilizer treatment) recruiting 60 subjects with DSM IV-TR bipolar disorder for a period of 8 weeks. Measures of cognition, psychopathology and laboratory indices will be utilized for evaluating primary and secondary outcomes, along with safety assessments.
Primary Outcome
Cognition was assessed using tests developed by The Cognition Group-(TCG); London, UK; and Delaware, USA. Testing procedures and consistency was assured by the same staff-patient dyad, and a TCG staff person had previously trained the research staff (Chengappa et al, 2012). A comprehensive cognitive battery was assessed. Details of these cognitive tests are available at http://www.cogtest.com, and are also described in other studies (Harvey et al, 2007, Lindenmayer et al, 2011, Chengappa et al,
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Sensoril
Study Locations (2)
Pennsylvania
- Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center - Pittsburgh
- Western Psychiatric Institute and Clinic - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2008-10 |
| Est. Completion | 2011-03 |
| Phase | Phase 3 |
What the finished NCT00761761 record still lists
NCT00761761 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 328-participant average among 26 other Bipolar I Disorder trials with a reported enrollment target (82% lower).
The record links to 3 conditions, with Bipolar I Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00761761 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT00761761 about?
NCT00761761 is a clinical study titled "Sensoril(Ashwaganhda)for Bipolar Disorder". The investigators hypothesis is that oral Sensoril® (as compared to placebo) will enhance cognitive abilities (specifically measures of attention, executive function, working memory, and visuospatial ability) in persons with bipolar disorder. Secondarily, the investigators hypothesize there will be ...
What is the current status of trial NCT00761761?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 60 participants. The study started on 2008-10. Estimated completion is 2011-03.
What conditions does trial NCT00761761 study?
This clinical trial studies the following conditions: Bipolar I Disorder, Bipolar II Disorder, Bipolar Disorder NOS.
What interventions are being tested in trial NCT00761761?
The interventions under investigation include: Placebo (OTHER), Sensoril (DRUG).
Who is sponsoring clinical trial NCT00761761?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00761761 being conducted?
This trial has 2 study locations across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Bipolar I 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 NCT00761761's enrollment target sits among peer trials
60 21st of 26 higher than 6 of 26 other Bipolar I Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar I 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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