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NCT00186186 · ClinicalTrials.gov registry record · Phase 4
Depakote ER in Bipolar Depression
A Phase 4 study of Depression, Bipolar, sponsored by Stanford University.
- Completed
- Registry status
- Phase 4
- Development phase
- 28
- Enrollment target
- 1
- Study location
NCT00186186: Completed Phase 4 study of Depression, Bipolar, sponsored by Stanford University.
NCT00186186 is a Phase 4 study of Depression, Bipolar that has completed, run by Stanford University. The registered enrollment target is 28 participants, below the 723-participant average among 5 other Depression, Bipolar trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00186186, a Phase 4 study of Depression, Bipolar, has completed, sponsored by Stanford University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 28 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar depression and to evaluate metabolic and GABA changes with Depakote ER administration using PET and MRI/MRS brain imaging techniques.
Primary Outcome
The Montgomery-Åsberg Depression Rating Scale (MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. Higher MADRS score indicates more severe depression the overall score ranges from 0 to 60. Usual cutoff points are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20 to 34 - moderate depression \>34 - severe depression.
Conditions Studied
Interventions
- DRUG Depakote ER
Study Locations (1)
California
- Stanford University Bipolar Disorders Clinic - Stanford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2004-01 |
| Est. Completion | 2009-01 |
| Phase | Phase 4 |
What the finished NCT00186186 record still lists
NCT00186186 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 723-participant average among 5 other Depression, Bipolar trials with a reported enrollment target (96% lower).
The record links to 1 condition, with Depression, Bipolar appearing as the primary indexed condition, and to 1 intervention - of which Depakote ER is the first listed.
NCT00186186 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT00186186 about?
NCT00186186 is a clinical study titled "Depakote ER in Bipolar Depression". The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar depression and to evaluate metabolic and GABA changes with Depakote ER administration using PET and MRI/MRS brain imaging techniques.
What is the current status of trial NCT00186186?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 28 participants. The study started on 2004-01. Estimated completion is 2009-01.
What conditions does trial NCT00186186 study?
This clinical trial studies the following conditions: Depression, Bipolar.
What interventions are being tested in trial NCT00186186?
The interventions under investigation include: Depakote ER (DRUG).
Who is sponsoring clinical trial NCT00186186?
This trial is sponsored by Stanford University, which has 1,744 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00186186 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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