Insulin Resistance in Patients With Mood Disorder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Natalie Rasgon, Stanford University
ClinicalTrials.gov Identifier:
NCT00242619
First received: October 19, 2005
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

Insulin resistance is known to be associated with mood disorders and cognitive difficulties. The purpose of this study is to treat depressed patients with rosiglitazone (also known as [AKA] Avandia), therefore improving glucose sensitivity, which in turn has the potential to affect mood and thinking. We, the researchers at Stanford University, are recruiting men and women who have been diagnosed with depression, and are willing to participate in this 3 month study. Participation involves neuropsychological testing, 2 blood draws called an oral glucose tolerance test (oGTT), which tests for glucose and insulin levels, and the medication, rosiglitazone. Participants are allowed to continue on their current psychiatric medication.


Condition Intervention
Depression
Bipolar Disorder
Insulin Resistance
Drug: rosiglitazone

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • 12-week mood state and neuropsychological battery [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
    mood state and neuropsychological battery


Enrollment: 10
Study Start Date: July 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: rosiglitazone
    Insulin resistance is known to be associated with mood disorders and cognitive difficulties. The purpose of this study is to treat depressed patients with rosiglitazone (also known as [AKA] Avandia), therefore improving glucose sensitivity, which in turn has the potential to affect mood and thinking. We, the researchers at Stanford University, are recruiting men and women who have been diagnosed with depression, and are willing to participate in this 3 month study. Participation involves neuropsychological testing, 2 blood draws called an oral glucose tolerance test (oGTT), which tests for glucose and insulin levels, and the medication, rosiglitazone. Participants are allowed to continue on their current psychiatric medication.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:- Current depression

  • Insulin resistance
  • Current physician/psychiatrist care
  • Between the ages of 18-60
  • Willing to sign the Human Subjects Protection Consent Form
  • Willing to have blood sampling

Exclusion Criteria:- Diabetes

  • History of unstable heat disease
  • Uncontrolled hypertension
  • Extensive use of alcohol
  • Current use of street drugs
  • History of myocardial infarction
  • History of cerebrovascular disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242619

Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Dr Natalie Rasgon Stanford University
  More Information

Additional Information:
No publications provided

Responsible Party: Natalie Rasgon, Principal Investigator, Stanford University
ClinicalTrials.gov Identifier: NCT00242619     History of Changes
Other Study ID Numbers: 95552
Study First Received: October 19, 2005
Last Updated: December 13, 2012
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 26, 2014