Insulin Resistance in Patients With Mood Disorder

NCT00242619 | Completed Results

• 1 other identifier: 95552
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Bipolar Disorder; Insulin Resistance

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale (HDRS-21)

  The Hamilton Depression Rating Scale (HDRS-21) measures depression severity on a scale from 0 to 21, with 0 being the lowest level of depression severity and 21 being the highest level of depression severity.

  12 weeks

• Clinical Global Impression-Severity Scale (CGI-S)

  The Clinical Global Impression-Severity Scale (CGI-S) assesses depression severity. It is a 7-point scale, where 1 is the lowest level of depression severity and 7 is the highest level of depression severity.

  12 weeks

Study Arms (1)

Rosiglitzone

EXPERIMENTAL

This group includes all 12 subjects who received rosiglitazone. Rosiglitazone was administered in addition to current antidepressant and/or mood-stabilizing medication at a dose of 4 mg/day for the first 4 weeks, with subsequent increase in dose to 9 mg/day for the remaining 8 weeks of the 12-week trial.

Drug: rosiglitazone

Interventions

rosiglitazone DRUG

Rosiglitazone was administered at two different doses over the 12-week period.

Also known as: Avandia

Rosiglitzone

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• History of unstable heat disease
• Uncontrolled hypertension
• Extensive use of alcohol
• Current use of street drugs
• History of myocardial infarction
• History of cerebrovascular disease

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Depression; Bipolar Disorder; Insulin Resistance

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Natalie Rasgon
• Organization: Stanford University

natalie.rasgon@stanford.edu

(650) 724-6689

Study Officials

• Dr Natalie Rasgon

  Stanford University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 19, 2005
• First Posted: October 20, 2005
• Study Start: July 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: February 14, 2017
• Results First Posted: February 14, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)