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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
34
An open-label 12-week trial of pioglitazone monotherapy. The investigators will titrate pioglitazone to the maximum tolerable dose up to 45mg per day.
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Change in the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR) Score
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
Time frame: Week 0 - Week 8
Change in Quick Inventory of Depressive Symptoms-Self Report (QIDS-SR16) Total Score
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
Time frame: Week 0 - Week 8
Response Rates on the IDS-CR, Montgomery Asberg Depression Rating Scale (MADRS) and Quick Inventory of Depressive Symptomatology-Self-Report (QIDS-SR)
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.
Time frame: Week 0 - Week 8
Remission Rates Based on IDS-CR, QIDS-SR, and MADRS Scores
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.
Time frame: Week 0 - Week 8
Change in Clinical Global Impressions-Bipolar Version (CGI-BP)
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.
Time frame: Week 0 - Week 8
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