Trial Outcomes & Findings for 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)? (NCT NCT00306475)

Last Updated: 2025-06-27

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

60 participants

Primary outcome timeframe

six weeks

Results posted on

2025-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Divalproex ER Divalproex ER 500 mg/bid	Placebo Placebo 500 mg/bid
Overall Study STARTED	30	30
Overall Study COMPLETED	30	30
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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)?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Divalproex ER n=30 Participants Divalproex 500 mgr ER Morning and Evening dose Active ingredient: Divalproex sodium 500 mgr capsule by mouth. two times daily, one capsule in the morning and one capsule in the evening, for 6 weeks	Placebo n=30 Participants Placebo Placebo: 2 capsules by mouth daily, one capsule in the morning and one capsule in the evening, for 6 weeks	Total n=60 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	45.93 years STANDARD_DEVIATION 11.23 • n=5 Participants	42 years STANDARD_DEVIATION 10.0206 • n=7 Participants	43.965 years STANDARD_DEVIATION 10.7387571 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants	16 Participants n=7 Participants	31 Participants n=5 Participants
Region of Enrollment United States	30 participants n=5 Participants	30 participants n=7 Participants	60 participants n=5 Participants

PRIMARY outcome

Timeframe: six weeks

Outcome measures

Outcome measures
Measure	Participants Which Received IP n=30 Participants divalproex sodium extended-release (ER): divalproex sodium extended-release (ER) 1000 mg	Participants Which Received Placebo n=30 Participants placebo identical in appearance to active comparator
Change in Cognition and Psychopathology Disorders as Measured on the MATRICS Consensus Cognitive Battery (MCCB)	14.1 units on a scale Standard Deviation 2.8	14.3 units on a scale Standard Deviation 2.7

Adverse Events

Divalproex Sodium

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Divalproex Sodium n=30 participants at risk Active ingredient: Divalproex sodium ER: Divalproex sodium ER1000 mg. Assigned participants taking Divalproex sodium ER1000 mg in addition to their Atypical Antipsychotic Drug.	Placebo n=30 participants at risk Placebo: Pill looks and tastes like the active ingredient but has no effect. Assigned participants taking Placebo in addition to their Atypical Antipsychotic Drug.
General disorders Any situation which makes the recurrence of severe Psychotic Symptoms, which is harmful to patients	0.00% 0/30	0.00% 0/30
Nervous system disorders Severe Suicidal Ideation or suicidal attempt	0.00% 0/30	0.00% 0/30

Other adverse events

Other adverse events
Measure	Divalproex Sodium n=30 participants at risk Active ingredient: Divalproex sodium ER: Divalproex sodium ER1000 mg. Assigned participants taking Divalproex sodium ER1000 mg in addition to their Atypical Antipsychotic Drug.	Placebo n=30 participants at risk Placebo: Pill looks and tastes like the active ingredient but has no effect. Assigned participants taking Placebo in addition to their Atypical Antipsychotic Drug.
General disorders Mild changes in patient's baseline state	0.00% 0/30	0.00% 0/30

Additional Information

Herbert Meltzer, M.D.

Vanderbilt Psychiatric Hospital

Phone: 615-327-7049

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place