CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 32 enrolled
Drug / intervention
Aripiprazoledrug
Likely dose
Aripiprazole 5-30 mg orally once daily for 12 weeksAI-extracted
Key inclusion· 5
  • ✓Diagnosis of bipolar disorder type I or II confirmed by M.I.N.I. structured interview
  • ✓Currently in depressed phase (with or without psychotic features) per DSM-IV/MINI criteria
  • ✓MADRS score greater than 19
  • ✓History of treatment-refractory bipolar depression: failure to respond to mood stabilizer monotherapy OR ≥2 mood stabilizers OR mood stabilizer plus antidepressant combination
Key exclusion· 8
  • ✕Prior treatment with divalproex and aripiprazole combination
  • ✕Current liver disease or illness precluding use of Depakote ER
  • ✕Active CNS neoplasms, demyelinating diseases, degenerative neurological conditions, or active CNS infection
  • ✕History of seizure, EEG with frank paroxysmal activity, brain CT showing gross structural abnormalities, cerebrovascular disease, or structural brain damage from trauma

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

Search/NCT00223496
NCT00223496Phase 4Completed
CompareCT.gov

12- Week Open Label Treatment of Refractory Bipolar Depression (BD) With Combination of Depakote ER (DEP) and Aripiprazole (AZP)

The University of Texas Health Science Center at San Antonio·interventional·Posted Sep 22, 2005·Updated May 16, 2017

In Brief

A Phase 4 clinical trial evaluating Aripiprazole for Bipolar Disorder. Completed, enrolled 32 participants across 1 site.

Detailed Summary

1. Determine the change in symptomatology and function in refractory bipolar depression, when treated with combination of DEP+AZP for a period of 12 weeks 2. Determine the tolerability and safety of AZP added to DEP in the treatment of refractory bipolar depression

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBipolar Disorder
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 22, 2005
Enrollment StartSep 1, 2004
Primary CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 20.8 years ago

Interventions

Aripiprazoledrug

Aripiprazole5mg - 30mg, every day (QD), for 12 weeks.