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Completed

NCT Number: NCT00194025

Valproate in Late Life Schizophrenia

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.

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Key information

Conditions

Schizophrenia Mental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospitals of Cleveland

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Depakote, Depakote ER

Primary outcomes

  1. Change in Schizophrenia Psychopathology as Assessed by the Positive and Negative Symptom Scale (PANSS)

    Time frame: Baseline to 12 weeks

    The best and worst possible overall PANSS scores are 30 and 210 units on a scale, respectively.

Secondary outcomes

  1. Change in Cognitive Status as Measured by the Mini-mental State Examination (MMSE)

    Time frame: Baseline to 12 weeks

    The best and worst possible overall scores are 31 and 0 units on a scale, respectively.

  2. Change in Overall Functioning as Measured by the Global Assessment Scale (GAS)

    Time frame: Baseline to 12 weeks

    The best and worst possible GAS scores are 100 and 1 units on a scale, respectively.

  3. Change in Depression Symptoms as Measured by the Geriatric Depression Scale (GDS)

    Time frame: Baseline to 12 weeks

    The best and worst possible GDS scores are 0 and 30 units on a scale, respectively.

  4. Change in Overall Mental Health Status as Measure by the Mental Composite Score (MCS) Subscale of the Short Form 36 Health Survey (SF-36)

    Time frame: Baseline to 12 weeks

    The best and worst possible MCS scores are 100 and 1 units on a scale, respectively.

  5. Change in Physical Health Status as Measure by the Physical Composite Score (PCS) Subscale of the Short Form 36 Health Survey (SF-36)

    Time frame: Baseline to 12 weeks

    The best and worst possible PCS scores are 100 and 0 units on a scale, respectively.

  6. Change in Extrapyramidal Symptoms as Assessed by the Abnormal Involuntary Movement Scale (AIMS)

    Time frame: Baseline to 12 weeks

    The best and worst possible overall scores are 0 and 28 units on a scale, respectively.

  7. Change in Extrapyramidal Symptoms as Assessed by the Simpson Angus Neurological Rating Scale (SAS)

    Time frame: Baseline to 12 weeks

    The best and worst possible overall scores are 40 and 0 units on a scale, respectively.

  8. Tolerability as Assessed by Weight Change

    Time frame: Baseline to 12 weeks

  9. Tolerability as Measured by Mean Serum Level at Study Endpoint

    Time frame: Baseline to 12 weeks

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Abbott

Registry information

Official study title

Add-on Valproate in Late Life Schizophrenia

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 19, 2005
Registry last updated
Jan 6, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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