CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 34 enrolled
Drug / intervention
Pioglitazonedrug
Likely dose
Pioglitazone 45mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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

Search/NCT00835120
NCT00835120Phase 4Completed
CompareCT.gov

Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance

University Hospitals Cleveland Medical Center·interventional·Posted Feb 3, 2009·Updated Jan 26, 2017

In Brief

A Phase 4 clinical trial evaluating Pioglitazone for Metabolic Syndrome and 2 related conditions. Completed, enrolled 34 participants across 1 site.

Detailed Summary

The study is an open-label 8-week adjunctive trial of pioglitazone for the acute relief of bipolar depression comorbid with metabolic syndrome/insulin resistance. Subjects who experience a partial or full response will have the option of continuing in an acute continuation phase lasting up to 12 weeks. The extension phase will allow assessment of the safety and tolerability of pioglitazone during the acute continuation period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMetabolic Syndrome, Bipolar Depression, Insulin Resistance
CountriesUnited States
CollaboratorsNational Alliance for Research on Schizophrenia and Depression, Takeda Pharmaceuticals North America, Inc.

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2009
Enrollment StartMar 1, 2009
Primary CompletionApr 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 17.4 years ago

Interventions

Pioglitazonedrug

An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.