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| Name | Class |
|---|---|
| National Alliance for Research on Schizophrenia and Depression | OTHER |
| Abbott | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
| |
| 2 | Placebo Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Divalproex Sodium Extended-Release Tablets | Drug | divalproex sodium extended-release (ER) 1000 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | six weeks |
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Inclusion criteria
Exclusion criteria
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| Name | Affiliation | Role |
|---|---|---|
| Stefania Bonaccorso, M.D. | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Psychiatric Hospital at Vanderbilt | Nashville | Tennessee | 37212 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Divalproex ER | Divalproex ER 500 mg/bid |
| FG001 | Placebo | Placebo 500 mg/bid |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| placebo |
| Drug |
placebo identical in appearance to active comparator |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Placebo | Placebo Placebo: 2 capsules by mouth daily, one capsule in the morning and one capsule in the evening, for 6 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | six weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Divalproex Sodium | Active ingredient: Divalproex sodium ER: Divalproex sodium ER1000 mg. Assigned participants taking Divalproex sodium ER1000 mg in addition to their Atypical Antipsychotic Drug. | 0 | 30 | 0 | 30 | 0 | 30 |
| EG001 | Placebo | Placebo: Pill looks and tastes like the active ingredient but has no effect. Assigned participants taking Placebo in addition to their Atypical Antipsychotic Drug. | 0 | 30 | 0 | 30 | 0 | 30 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Any situation which makes the recurrence of severe Psychotic Symptoms, which is harmful to patients | General disorders | Systematic Assessment |
| ||
| Severe Suicidal Ideation or suicidal attempt | Nervous system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild changes in patient's baseline state | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Herbert Meltzer, M.D. | Vanderbilt Psychiatric Hospital | 615-327-7049 | herbert.meltzer@vanderbilt.edu |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| >=65 years |
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| Male |
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