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NCT00194116 · ClinicalTrials.gov registry record · Phase 3
Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression
A Phase 3 study of Bipolar Disorder, sponsored by University Hospitals Cleveland Medical Center.
- Completed
- Registry status
- Phase 3
- Development phase
- 54
- Enrollment target
- 1
- Study location
NCT00194116 is a Phase 3 study of Bipolar Disorder that has completed, run by University Hospitals Cleveland Medical Center. The registered enrollment target is 54 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00194116, a Phase 3 study of Bipolar Disorder, has completed, sponsored by University Hospitals Cleveland Medical Center.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 54 participants
- Enrollment target
- 1
- Study location
Study Summary
Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently experiencing an episode of major depression. Patients are randomized to double-blind treatment with divalproex sodium ER or placebo and remain in the study for up to six weeks. This six-week double-blind treatment period is followed by an open-label treatment period of six months duration. This study is sponsored by Abbott Laboratories.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Divalproex Sodium ER
Study Locations (1)
Ohio
- University Hospitals of Cleveland - Cleveland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2004-09 |
| Est. Completion | 2008-02 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00194116
The ClinicalTrials.gov registry entry for NCT00194116 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (84% lower). The listed sponsor is University Hospitals Cleveland Medical Center, which has 230 total studies on file at ClinicalTrials.gov.
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.
NCT00194116 reports 1 study location spanning 1 distinct geographic area - top geographies include Ohio.
Frequently Asked Questions
What is clinical trial NCT00194116 about?
NCT00194116 is a clinical study titled "Double-blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression". Double-Blind, Placebo-Controlled Divalproex Sodium ER in Bipolar I or Bipolar II Depression Previously Diagnosed and Treated as Recurrent Major Depression: This study recruits males and females aged 18 - 70 who currently meet diagnostic criteria for bipolar I or bipolar II disorder and are currently...
What is the current status of trial NCT00194116?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 54 participants. The study started on 2004-09. Estimated completion is 2008-02.
What conditions does trial NCT00194116 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT00194116?
The interventions under investigation include: Placebo (DRUG), Divalproex Sodium ER (DRUG).
Who is sponsoring clinical trial NCT00194116?
This trial is sponsored by University Hospitals Cleveland Medical Center, which has 230 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00194116 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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