Pioglitazone for the Treatment of Bipolar Depression
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Double-Blind, Placebo-Controlled Trial of Pioglitazone for Bipolar Depression|
- Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) total score [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
- Change in insulin resistance as quantified by homeostatic model assessment for insulin resistance (HOMA-IR) [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
- Change in fasting lipid profile [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
|Study Start Date:||September 2012|
|Study Completion Date:||March 2016|
|Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
Other Name: Actos
|Placebo Comparator: Placebo||
Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
Other Name: Sugar Pill
The study is a double-blind, placebo-controlled 8-week trial of pioglitazone, either as monotherapy or adjunctive to a mood stabilizer, for the acute relief of bipolar depression. The enrollment goal is 80 subjects (40 patients each in the pioglitazone treatment group and the placebo treatment group).
Screening Phase: Patients who have been prescribed a mood stabilizer for > 4 weeks and are on a therapeutic dose will proceed directly to the Screening Visit. For situations in which the patient prefers to be taking a mood stabilizer or where the treating psychiatrist feels it is clinically necessary, a mood stabilizer (lithium, divalproex, carbamazepine, lamotrigine, olanzapine, quetiapine, risperidone, aripiprazole, ziprasidone or lurasidone) will be initiated (see Mood Stabilizer Initiation section below). For this set of patients who do begin a mood stabilizer, the Screening Phase may last up to 8 weeks. Otherwise, subjects who do not come in on a mood stabilizer will proceed directly to screening.
Double-Blind, Placebo-Controlled Study Period (Week 1 to Week 8): Patients who meet inclusion/exclusion criteria will be randomized to study treatment at the baseline/randomization visit within 30 days of the screening visit. The efficacy and safety assessments will be carried out at baseline/randomization and then weekly or every two weeks for a total of 8 weeks.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01717040
|United States, Ohio|
|University Hospitals Case Medical Center - Mood Disorders Program|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||David Kemp, MD||University Hospital Case Medical Center|