Pioglitazone in Patients With Mood Disorders
Recruitment status was: Recruiting
The purpose of this study is to see how an insulin sensitizing medication, Pioglitazone, can cause changes in mood in some depressed patients. Study participants receive assessment of their cognitive and metabolic functioning.
If they meet criteria, they will be asked to take either Pioglitazone or a placebo for a 90-day trial. Participants will undergo an Oral Glucose Tolerance Test to measure fasting insulin and glucose levels, as well as routine blood testing.
The investigators hope to quantify the role of Pioglitazone in patients with mood disorders and compare the values to those previously obtained in a healthy age-matched control population. The investigators also hope to examine the association between IR and cognitive performance and clinical course of depression in patients with mood disorders.
Major Depressive Disorder
Drug: Sugar Pill
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Pioglitazone Treatment for Insulin Resistant Patients With Mood Disorders|
- Hamilton Rating Scale for Depression: change from baseline to 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]The Hamilton rating will be assessed at baseline, at 1 month after starting the drug course, at 2 months after starting the drug course, and after the drug course is over at 3 months.
- Fasting Insulin Measurements: change from baseline to 3 months [ Time Frame: 3 months ] [ Designated as safety issue: No ]Fasting insulin measurements will be taken at baseline, at 1 month after starting drug course, at 2 months after starting drug course, and after the drug course is completed at 3 months.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||June 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
|Active Comparator: Pioglitazone||
15mg once daily for 15 days, 30mg once daily for 15 days, 45mg once daily for 60 days
|Placebo Comparator: Sugar pill||
Drug: Sugar Pill
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559857
|United States, California|
|Stanford University Department of Psychiatry & Behavioral Sciences|
|Palo Alto, California, United States, 94305|
|Principal Investigator:||Natalie Rasgon, MD, PhD||Stanford University|