Pioglitazone for the Treatment of Bipolar Depression
|ClinicalTrials.gov Identifier: NCT01717040|
Recruitment Status : Terminated (The study ended early due to budgetary issues)
First Posted : October 30, 2012
Results First Posted : January 27, 2017
Last Update Posted : January 27, 2017
|Condition or disease||Intervention/treatment||Phase|
|Bipolar Disorder Insulin Resistance||Drug: Pioglitazone Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||37 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Double-Blind, Placebo-Controlled Trial of Pioglitazone for Bipolar Depression|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
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
- Change in Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) Total Score [ Time Frame: Baseline and Week 8 ]Inventory of Depressive Symptomatology-Clinician Rated (IDS-C30) is designed to assess the severity of depressive symptoms. Total scores can range from 0 to 84 with higher scores indicating a higher severity of depressive symptoms
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01717040
|United States, Ohio|
|University Hospitals Cleveland Medical Center - Mood Disorders Program|
|Cleveland, Ohio, United States, 44106|
|Principal Investigator:||David Kemp, MD||University Hospitals Cleveland Medical Center|