Pioglitazone for the Treatment of Bipolar Disorder and Comorbid Metabolic Syndrome or Insulin Resistance
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|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|
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|