Schizoaffective Disorder, Schizophrenia
Conditions
Keywords
schizophrenia, cognition, mood stabilizer
Brief 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.
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. 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.
Interventions
divalproex sodium extended-release (ER) 1000 mg
DRUGplacebo
placebo identical in appearance to active comparator
Sponsors
National Alliance for Research on Schizophrenia and Depression
Abbott
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognition and Psychopathology Disorders as Measured on the MATRICS Consensus Cognitive Battery (MCCB) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Divalproex ER 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 | 30 |
| Placebo Placebo
Placebo: 2 capsules by mouth daily, one capsule in the morning and one capsule in the evening, for 6 weeks | 30 |
| Total | 60 |
Baseline characteristics
| Characteristic | Placebo | Divalproex ER | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 42 years STANDARD_DEVIATION 10.0206 | 45.93 years STANDARD_DEVIATION 11.23 | 43.965 years STANDARD_DEVIATION 10.7387571 |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 14 Participants | 15 Participants | 29 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
Primary
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.
Time frame: six weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Participants Which Received IP | 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 |
| Participants Which Received Placebo | Change in Cognition and Psychopathology Disorders as Measured on the MATRICS Consensus Cognitive Battery (MCCB) | 14.3 units on a scale | Standard Deviation 2.7 |