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Pioglitazone in Patients With Mood Disorders

This study is currently recruiting participants.
Verified March 2012 by Stanford University
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01559857
First received: March 16, 2012
Last updated: March 19, 2012
Last verified: March 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Major Depressive Disorder
Insulin Resistance
 Drug: Pioglitazone
Drug: Sugar Pill
 Phase 4

Study Type: Interventional
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
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)
Arms Assigned Interventions
Active Comparator: Pioglitazone Drug: 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
Placebo

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01559857

Contacts
Contact: Rachael Lazar 650-724-4559 rlazar@stanford.edu

Locations
United States, California
Stanford University Department of Psychiatry & Behavioral Sciences Recruiting
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Investigators
Principal Investigator: Natalie Rasgon, MD, PhD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01559857     History of Changes
Other Study ID Numbers: R21 MH093948-01A1
Study First Received: March 16, 2012
Last Updated: March 19, 2012
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by Stanford University:
Depression
Insulin resistance
Mood disorder

Additional relevant MeSH terms:
Depressive Disorder
Depression
Insulin Resistance
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013