Pioglitazone for the Treatment of Bipolar Depression
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
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): 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|