CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Valproatedrug
Likely dose
Valproate semisodium 500 mg extended-release at bedtime (after 2-week titration from 250 mg)AI-extracted
Key inclusion· 5
  • ✓Diagnosis of schizophrenia confirmed by MINI
  • ✓Currently on antipsychotic medication
  • ✓Age 50 years or older
  • ✓Able to provide written informed consent (or guardian consent if applicable)
Key exclusion· 3
  • ✕Primary psychiatric DSM Axis I diagnosis other than schizophrenia
  • ✕Active substance abuse
  • ✕Medical instability

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00194025
NCT00194025Phase 4Completed
CompareCT.gov

Add-on Valproate in Late Life Schizophrenia

University Hospitals Cleveland Medical Center·interventional·Posted Sep 19, 2005·Updated Jan 6, 2015

In Brief

A Phase 4 clinical trial evaluating Valproate for Schizophrenia. Completed, enrolled 20 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSchizophrenia
CountriesUnited States
CollaboratorsAbbott

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartNov 1, 2004
Primary CompletionNov 1, 2006
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 20.8 years ago

Interventions

Valproatedrug

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.