Insulin Resistance in Patients With Mood Disorder

Depression Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00242619
• Other study ID #: 95552
• Status: Completed
• Phase: N/A
• First received: October 19, 2005
• Last updated: December 13, 2012
• Start date: July 2007
• Est. completion date: December 2009

Study information

• Verified date: December 2012
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Insulin Resistance

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12-week mood state and neuropsychological battery	mood state and neuropsychological battery	12 weeks	Yes

External Links

•   Stanford University Behavioral Neuroendocrinology Program