SchizophreniaPhase 4NCT00306475

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 testing Divalproex Sodium Extended-Release Tablets in people with Schizophrenia and Schizoaffective Disorder, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Schizophrenia, Schizoaffective Disorder
What is being tested?: Divalproex Sodium Extended-Release Tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: 1 siteUnited States
Study dates: Mar 2006to Apr 2008
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, age 18-65
Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
Treated with olanzapine, aripiprazole, ziprasidone, quetiapine or risperidone monotherapy for at least three months prior to enrollment
Able to provide written consent

Who cannot join

Primary DSM-IV diagnosis other than schizophrenia or schizoaffective disorder
Treatment with any antipsychotic other than olanzapine, aripiprazole, ziprasidone, quetiapine or risperidone in the past three months
Treatment with a mood stabilizer or an antidepressant continuously in the past three months. Patients who have had it for less than two weeks continuously will be permitted to enter.
Pregnant or lactating females

Trial locations and contacts

1 site in 1 country.

United States1 site

Psychiatric Hospital at Vanderbilt
Nashville, Tennessee, 37212

Other trials in United States

About this study

Read the detailed description

Cognitive function is one of the most critical deficits in schizophrenia and schizoaffective disorder. It has been found that cognitive dysfunction may be even more important than positive or negative symptoms in predicting functional outcomes such as community adjustment, ability to work, social interactions, and caretaker burden. Preclinical data from our laboratory provided the rationale for a clinical trial to test whether divalproex sodium ER can improve cognitive impairment in patients.

Conditions: Schizophrenia, Schizoaffective Disorder
Being tested: Divalproex Sodium Extended-Release Tablets, placebo
Keywords: schizophrenia, cognition, mood stabilizer
Medical subject headings: Schizophrenia, Psychotic Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Divalproex Sodium Extended-Release TabletsDrug
divalproex sodium extended-release (ER) 1000 mg
placeboDrug
placebo identical in appearance to active comparator

Study groups in NCT00306475
Study group	Role	What they receive
1	Active comparator	Not described Receives: Drug: Divalproex Sodium Extended-Release Tablets
2	Placebo comparator	Not described Receives: Drug: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Cognition and Psychopathology Disorders as Measured on the MATRICS Consensus Cognitive Battery (MCCB)
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 indicate impaired cognitive functioning, while scores above 60 suggest above-average cognitive abilities.
The MCCB is often used in clinical research to assess cognitive deficits in individuals with psychiatric disorders, and the T-score scale is used to track cognitive changes over time.
Measured: six weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2006Apr 2008

First posted23 Mar 2006 (estimated)
Study startMar 2006
Primary completionApr 2008
Study completionApr 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00306475
Sponsor's protocol ID: 051231
Status last verified: Apr 2022
First submitted: 22 Mar 2006
Last updated: 27 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 27 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)?
ClinicalTrials.gov ID: NCT00306475
Acronym / sponsor ID: 051231
Conditions: Schizophrenia, Schizoaffective Disorder
Keywords: schizophrenia, cognition, mood stabilizer
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: National Alliance for Research on Schizophrenia and Depression, Abbott
Study start: Mar 2006
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 23 Mar 2006 (estimated)
Results: Posted 27 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: Divalproex Sodium Extended-Release Tablets
2	Placebo comparator	Drug: placebo

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Male or female, age 18-65
Diagnostic and Statistical Manual (DSM-IV) diagnosis of schizophrenia or schizoaffective disorder
Treated with olanzapine, aripiprazole, ziprasidone, quetiapine or risperidone monotherapy for at least three months prior to enrollment
Able to provide written consent

Key exclusion criteria (4 listed)

Primary DSM-IV diagnosis other than schizophrenia or schizoaffective disorder
Treatment with any antipsychotic other than olanzapine, aripiprazole, ziprasidone, quetiapine or risperidone in the past three months
Treatment with a mood stabilizer or an antidepressant continuously in the past three months. Patients who have had it for less than two weeks continuously will be permitted to enter.
Pregnant or lactating females

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Divalproex Sodium Extended-Release Tabletsdivalproex sodium extended-release (ER) 1000 mg	Drug	1
placeboplacebo identical in appearance to active comparator	Drug	2

Primary outcome

Change in Cognition and Psychopathology Disorders as Measured on the MATRICS Consensus Cognitive Battery (MCCB)
Time frame: six weeks
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 indicate impaired cognitive functioning, while scores above 60 suggest above-average cognitive abilities. The MCCB is often used in clinical research to assess cognitive deficits in individuals with psychiatric disorders, and the T-score scale is used to track cognitive changes over time.

Results and safety

Results posted to the registry on 27 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Divalproex ER	30	30
Placebo	30	30

Primary outcome: Change in Cognition and Psychopathology Disorders as Measured on the MATRICS Consensus Cognitive Battery (MCCB)

Time frame: six weeks. Mean (Standard Deviation). Unit: units on a scale

Measure	Participants Which Received IP n = 30	Participants Which Received Placebo n = 30
Value	14.1 (2.8)	14.3 (2.7)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Divalproex Sodium	0 of 30 (0%)	0 of 30 (0%)	0 of 30
Placebo	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stefania Bonaccorso, M.D. principal investigator

Vanderbilt University Medical Center

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Divalproex Sodium Extended-Release Tablets in people with Schizophrenia and Schizoaffective Disorder, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Cognition and Psychopathology Disorders as Measured on the MATRICS Consensus Cognitive Battery (MCCB) (time frame: six weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00306475.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2025.