Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
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 Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance|
- Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]Inventory of Depressive Symptoms-Clinician rated, 30 item (IDS-C30) score change from baseline to study endpoint. IDS-C30 total scores can range from 0 to 84, with higher scores indicating a worse outcome
- Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]The QIDS-SR16 is a 16-item, self report assessment. Total scores can range from 0 to 27, with higher scores indicating a worse outcome
- Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR) [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
- Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]
- Change in Clinical Global Impressions-Bipolar Version (CGI-BP) [ Time Frame: Week 0 - Week 8 ] [ Designated as safety issue: No ]The CGI-BP asks the clinician one question: "Considering your total clinical experience with this particular population, how mentally ill is the patient at this time?" which is rated on the following seven-point scale: 1=normal, not at all ill; 2=borderline mentally ill; 3=mildly ill; 4=moderately ill; 5=markedly ill; 6=severely ill; 7=among the most extremely ill patients.
|Study Start Date:||March 2009|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
Pioglitazone has been approved by the U.S. Food and Drug Administration (FDA) to help people who are diagnosed with diabetes
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
Other Name: Actos
Please refer to this study by its ClinicalTrials.gov identifier: NCT00835120
|United States, Ohio|
|University Hospitals Case Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||David E Kemp, MD||Univeristy Hospitals Case Medical Center|