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| Name | Class |
|---|---|
| Abbott | INDUSTRY |
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The purpose of this research study is to analyze the effectiveness and tolerability of a medication, valproate ( Depakote and Depakote ER), in individuals age 50 years and older who have schizophrenia.
It is known that up to 30% of individuals with schizophrenia continue to have symptoms even when treated with current FDA-approved medications intended to treat their schizophrenia. Anticonvulsant medications such as valproate (Depakote and Depakote ER) are known to be effective for related conditions such as bipolar disorder (manic depressive illness), and are also used by some physicians in clinical settings in combination with antipsychotic medications to treat symptoms of schizophrenia. Currently Depakote and Depakote ER are approved by the FDA to treat bipolar disorder and to treat seizure disorder. This study will test to see if Depakote and Depakote ER may improve symptoms of schizophrenia as well when added to antipsychotic medications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| valproate | Experimental | All participants received open-label, add-on valproate. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Valproate | Drug | Enrolled individuals received adjunctive, open-label valproate semisodium, initially started as valproate semisodium delayed -release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended- release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50-100 µg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS) | The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively. | Baseline to 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE) | The best and worst possible overall scores are 31 and 0 units on a scale, respectively. | Baseline to 12 weeks |
| Change in Overall Functioning as Measured by the Global Assessment Scale (GAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martha Sajatovic, MD | Case Western Reserve University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17582828 | Result | Sajatovic M, Coconcea N, Ignacio RV, Blow FC, Hays RW, Cassidy KA, Meyer WJ. Adjunct extended-release valproate semisodium in late life schizophrenia. Int J Geriatr Psychiatry. 2008 Feb;23(2):142-7. doi: 10.1002/gps.1854. |
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The study was conducted at an academic psychiatry clinic in the mid-western United States. Data was collected from participants from February 2004 to November 2006. Participants were recruited in response to self-referrals from advertisements and by referrals from mental health practitioners.
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| ID | Title | Description |
|---|---|---|
| FG000 | Valproate | Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Valproate | Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS) | The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively. | Last Observation Carried Forward (LOCF) was used as the imputation technique. | Posted | Jan 2009 | Mean | Standard Deviation | scores on a scale | Baseline to 12 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 | Valproate | Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50- 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime. |
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The findings of this study must be interpreted cautiously given the limitations of small sample size, open-label, add-on design and lack of a control or comparator group. The mean age of 61 years is not representative of the "old-old" populations.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martha Sajatovic MD | Case Western Reserve University and Unversity Hospitals Case Medical Center | 216-844-2808 | martha.sajatovic@uhhospitals.org |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D014635 | Valproic Acid |
| ID | Term |
|---|---|
| D010421 | Pentanoic Acids |
| D014631 | Valerates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
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The best and worst possible GAS scores are 100 and 1 units on a scale, respectively. |
| Baseline to 12 weeks |
| Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS) | The best and worst possible GDS scores are 0 and 30 units on a scale, respectively. | Baseline to 12 weeks |
| Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) | The best and worst possible MCS scores are 100 and 1 units on a scale, respectively. | Baseline to 12 weeks |
| Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) | The best and worst possible PCS scores are 100 and 0 units on a scale, respectively. | Baseline to 12 weeks |
| Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS) | The best and worst possible overall scores are 0 and 28 units on a scale, respectively. | Baseline to 12 weeks |
| Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS) | The best and worst possible overall scores are 40 and 0 units on a scale, respectively. | Baseline to 12 weeks |
| Tolerability as Assessed by Weight Change | Baseline to 12 weeks |
| Tolerability as Measured by Mean Serum Level at Study Endpoint | Baseline to 12 weeks |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE) | The best and worst possible overall scores are 31 and 0 units on a scale, respectively. | Last Observation Carried Forward (LOCF) was used as the imputation technique. | Posted | Jan 2009 | Mean | Standard Deviation | scores on a scale | Baseline to 12 weeks |
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| Secondary | Change in Overall Functioning as Measured by the Global Assessment Scale (GAS) | The best and worst possible GAS scores are 100 and 1 units on a scale, respectively. | Last Observation Carried Forward (LOCF) was used as the imputation technique. | Posted | Jan 2009 | Mean | Standard Deviation | scores on a scale | Baseline to 12 weeks |
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|
|
| Secondary | Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS) | The best and worst possible GDS scores are 0 and 30 units on a scale, respectively. | Last Observation Carried Forward (LOCF) was used as the imputation technique. | Posted | Jan 2009 | Mean | Standard Deviation | scores on a scale | Baseline to 12 weeks |
|
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| Secondary | Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36) | The best and worst possible MCS scores are 100 and 1 units on a scale, respectively. | The number of participants for analysis was based on available data. Last Observation Carried Forward (LOCF) was used as the imputation technique. | Posted | Jan 2009 | Mean | Standard Deviation | scores on a scale | Baseline to 12 weeks |
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| Secondary | Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) | The best and worst possible PCS scores are 100 and 0 units on a scale, respectively. | Last Observation Carried Forward (LOCF) was used as the imputation technique. | Posted | Jan 2009 | Mean | Standard Deviation | scores on a scale | Baseline to 12 weeks |
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| Secondary | Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS) | The best and worst possible overall scores are 0 and 28 units on a scale, respectively. | Last Observation Carried Forward (LOCF) was used as the imputation technique. | Posted | Jan 2009 | Mean | Standard Deviation | scores on a scale | Baseline to 12 weeks |
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|
| Secondary | Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS) | The best and worst possible overall scores are 40 and 0 units on a scale, respectively. | Last Observation Carried Forward (LOCF) was used as the imputation technique. | Posted | Jan 2009 | Mean | Standard Deviation | scores on a scale | Baseline to 12 weeks |
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| Secondary | Tolerability as Assessed by Weight Change | All available data was used implementing LOCF. | Posted | Mean | Standard Deviation | kilograms | Baseline to 12 weeks |
|
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| Secondary | Tolerability as Measured by Mean Serum Level at Study Endpoint | Last Observation Carried Forward (LOCF) was used as the imputation technique. | Posted | Mean | Standard Deviation | ug/mL | Baseline to 12 weeks |
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| 0 |
| 20 |
| 0 |
| 20 |
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| D009930 |
| Organic Chemicals |
| D005232 | Fatty Acids, Volatile |
| D005227 | Fatty Acids |
| D008055 | Lipids |