Pioglitazone in Patients With Mood Disorders

Major Depressive Disorder Clinical Trial

Official title:

Pioglitazone Treatment for Insulin Resistant Patients With Mood Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01559857
• Other study ID #: R21MH093948-01A1
• Status: Recruiting
• Phase: Phase 4
• First received: March 16, 2012
• Last updated: March 19, 2012
• Start date: November 2011
• Est. completion date: June 2014

Study information

• Verified date: March 2012
• Source: Stanford University
• Contact: Rachael Lazar
• Phone: 650-724-4559
• Email: rlazar[@]stanford.edu
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age between 20 and 65 years

• BMI between 25 and 35

• Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD) or depressive episode of bipolar disorder (Bipolar I, II or NOS)

• Depression severity as defined by score of < 12 on the 21-item Hamilton Rating Scale for Depression and no psychiatric admission within 6 months from study entry and no suicide attempt within the last 12 months

• Willingness to sign human subjects consent form

Exclusion Criteria:

• Diagnosis of possible or probable cognitive impairment

• For women only: pregnancy, breastfeeding

• Personal history of Type I or Type II diabetes

• Unstable cardiovascular disease or other major medical condition, or history of myocardial infarction within the previous year

• Significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressures > 100)

• Current drug or alcohol abuse

• History of neurological disorder, e.g. multiple sclerosis, stroke etc

• Use of any drug that may significantly affect psychometric testing or the insulin testing

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Insulin Resistance
• Major Depressive Disorder
• Mood Disorders

Intervention

Drug:
• Pioglitazone
15mg once daily for 15 days, 30mg once daily for 15 days, 45mg once daily for 60 days
• Sugar Pill
Placebo

Locations

Country	Name	City	State
United States	Stanford University Department of Psychiatry & Behavioral Sciences	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Rating Scale for Depression: change from baseline to 3 months	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.	3 months	No
Secondary	Fasting Insulin Measurements: change from baseline to 3 months	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.	3 months	No