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NCT00306475 · ClinicalTrials.gov registry record · Phase 4
Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)?
A Phase 4 study, sponsored by Northwestern University.
- Completed
- Registry status
- Phase 4
- Development phase
- 60
- Enrollment target
NCT00306475: Completed Phase 4 study, sponsored by Northwestern University.
NCT00306475 is a Phase 4 study that has completed, run by Northwestern University. The registered enrollment target is 60 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00306475, a Phase 4 study, has completed, sponsored by Northwestern University.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 60 participants
- Enrollment target
Study Summary
The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of 6 weeks duration in patients with schizophrenia or schizoaffective disorder.
Primary Outcome
Giving Divalproex Sodium ER to Outpatients with Schizophrenia and Schizoaffective Disorder in addition to taking Atypical Antipsychotic Drug has shown to change their cognition and psychopathology. The MCCB measures cognitive function. The MCCB provides an overall composite score, expressed as a T-score, with a mean of 50 and a standard deviation of 10 The MCCB does not have minimum and maximum scores due to the use of T scores. A typical score will fall within a range of 40-60. Scores below 40
Interventions
- DRUG placebo
- DRUG Divalproex Sodium Extended-Release Tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2006-03 |
| Est. Completion | 2008-04 |
| Phase | Phase 4 |
What the finished NCT00306475 record still lists
NCT00306475 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 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (88% lower).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00306475 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00306475 about?
NCT00306475 is a clinical study titled "Does The Addition Of Divalproex Sodium ER To An Atypical Antipsychotic Drug (APD) Improve Cognition And Psychopathology In Outpatients With Schizophrenia (SCH) Or Schizoaffective Disorder (SAD)?". The major objective of this proposal is to test the hypothesis that the addition of divalproex sodium to an atypical antipsychotic drug other than clozapine will significantly improve: a) cognition; and b) psychopathology (positive, negative, and mood symptoms) in a double-blind, randomized trial of...
What is the current status of trial NCT00306475?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 60 participants. The study started on 2006-03. Estimated completion is 2008-04.
What interventions are being tested in trial NCT00306475?
The interventions under investigation include: placebo (DRUG), Divalproex Sodium Extended-Release Tablets (DRUG).
Who is sponsoring clinical trial NCT00306475?
This trial is sponsored by Northwestern University, which has 1,209 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00306475's enrollment target sits among peer trials
60 1125th of 2000 higher than 799 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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