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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: Completed Phase 3 study of Bipolar Disorder, sponsored by University Hospitals Cleveland Medical Center.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
MADRS total scores range from 0-60, where higher scores are indicative of more depression.
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 |
What the finished NCT00194116 record still lists
NCT00194116 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (84% 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.
NCT00194116 reports a single indexed study location in 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.
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 NCT00194116's enrollment target sits among peer trials
54 102nd of 162 higher than 59 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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