Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
|ClinicalTrials.gov Identifier: NCT00835120|
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : October 17, 2014
Last Update Posted : January 26, 2017
|Condition or disease||Intervention/treatment||Phase|
|Metabolic Syndrome Bipolar Depression Insulin Resistance||Drug: Pioglitazone||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
U.S. FDA Resources
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
- Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score [ Time Frame: Week 0 - Week 8 ]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 ]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 ]A participant is considered to have responded if their total score on either the MADRS or QIDS-SR16 decreases by at least 50% between their Week 0 visit and Week 8 visit.
- Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores [ Time Frame: Week 0 - Week 8 ]A participant is considered in remission if their total score on the MADRS is > 7, their total score on the QIDS-SR16 > 6 and/or their total score on the IDS-CR is > 12 at Week 8.
- Change in Clinical Global Impressions-Bipolar Version (CGI-BP) [ Time Frame: Week 0 - Week 8 ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00835120
|United States, Ohio|
|University Hospitals Cleveland Medical Center|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||David E Kemp, MD||University Hospitals Cleveland Medical Center|