Pioglitazone for the Treatment of Bipolar Depression
The primary objective is to test the hypothesis that adjunctive pioglitazone is more effective than placebo for the relief of acute depressive symptoms resulting from bipolar disorder. The secondary objectives are to determine potential moderators and mediators of antidepressant efficacy.
|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|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (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
|Contact: Carla Conroy, BA||216-844-2871||Carla.Conroy@UHhospitals.org|
|United States, Ohio|
|University Hospitals Case Medical Center - Mood Disorders Program||Recruiting|
|Cleveland, Ohio, United States, 44106|
|Contact: Carla Conroy, BA 216-844-2871 Carla.Conroy@UHhospitals.org|
|Principal Investigator: David Kemp, MD|
|Principal Investigator:||David Kemp, MD||University Hospital Case Medical Center|