CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 28 enrolled
Drug / intervention
Depakote ERdrug
Likely dose
Not stated in record
Key inclusion· 3
  • ✓Diagnosed with Bipolar I, II, or NOS currently experiencing a depressive episode
  • ✓Age 18 years or older
  • ✓Any race and both female and male participants
Key exclusion· 7
  • ✕Schizophrenia or schizoaffective disorder
  • ✕Substance dependence within past 3 months or substance abuse within past 2 weeks
  • ✕Positive urine drug screen for psychoactive drugs or drugs of abuse (excluding marijuana if no dependence/abuse)
  • ✕Significant risk of harm to self or others based on history or mental status

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

Search/NCT00186186
NCT00186186Phase 4Completed
CompareCT.gov

Depakote ER in Bipolar Depression

Stanford University·interventional·Posted Sep 16, 2005·Updated Apr 12, 2017

In Brief

A Phase 4 clinical trial evaluating Depakote ER for Depression, Bipolar. Completed, enrolled 28 participants across 1 site.

Detailed Summary

The purpose of this study is to examine the safety and efficacy of Depakote ER in bipolar depression and to evaluate metabolic and GABA changes with Depakote ER administration using PET and MRI/MRS brain imaging techniques.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDepression, Bipolar
CountriesUnited States
CollaboratorsAbbott, National Alliance for Research on Schizophrenia and Depression

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 16, 2005
Enrollment StartJan 1, 2004
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.8 years ago

Interventions

Depakote ERdrug

Depakote ER