Phase 4
Completed N=20
Valproate in Late Life Schizophrenia
Source: ClinicalTrials.gov NCT00194025 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2011
Primary outcomePrimary: Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS) — -17.45 scores on a scale — p=<0.001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS) |
-17.45 | <0.001 sig |
| SECONDARY Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE) |
0.4 | 0.585 |
| SECONDARY Change in Overall Functioning as Measured by the Global Assessment Scale (GAS) |
16.35 | <0.001 sig |
| SECONDARY Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS) |
-1.556 | 0.017 sig |
| 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) |
5.298 | 0.027 sig |
| SECONDARY Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36) |
0.932 | 0.569 |
| SECONDARY Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS) |
-2.105 | 0.038 sig |
| SECONDARY Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS) |
-0.6 | 0.199 |
| SECONDARY Tolerability as Assessed by Weight Change |
1.1 | 0.21 |
| SECONDARY Tolerability as Measured by Mean Serum Level at Study Endpoint |
40.86 | — |
Eligibility Criteria
Inclusion Criteria
- Must have a diagnosis of schizophrenia as confirmed by the MINI
- Must be on antipsychotic medication
- Must be age 50 year or older
- Must be capable of providing written informed consent for study participation. In situations where individuals have guardians of person, guardian and subject must both provide written consent; and
- Must live in the Northeast Ohio area.
Exclusion Criteria
- A primary psychiatric DSM Axis I diagnosis other than schizophrenia
- Actively abusing substances; or
- Medically unstable.
Data sourced from ClinicalTrials.gov (NCT00194025). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.