Overview

This trial is active, not recruiting.

Conditions depression, bipolar disorder, mood disorders, insulin resistance, depressive disorder, major, depressive disorder
Sponsor Stanford University
Collaborator American Diabetes Association
Start date July 2009
End date January 2016
Trial size 90 participants
Trial identifier NCT01106313, SU-02172010-5003, eProtocol 17089

Summary

The purpose of this study is to study the relationship between insulin and glucose action and neuropsychological functioning (memory, attention, general thinking abilities) in persons with depression.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional

Primary Outcomes

Measure
To quantify insulin-mediated glucose uptake as assessed by the SSPG concentration in patients with depression and compare the values to those previously obtained in a healthy age-matched control population
time frame: Within 3 hours of initial infusion

Secondary Outcomes

Measure
To examine the association between insulin resistance and cognitive performance and clinical course of depression in patients with depression
time frame: 1 wk

Eligibility Criteria

Male or female participants from 20 years up to 65 years old.

Inclusion Criteria:1)Willingness to sign the Human Subject Protection Consent Form prior to enrollment into the study. 2)Men and women ages 20 to 65 years of age. 3)Diagnosis of unipolar, non-psychotic, non-melancholic major depressive disorder (MDD) or depressive episode of bipolar disorder (Bipolar I, II or NOS), based on a Structured Clinical Interview for DSM-IV Axis I disorders (SCID) and confirmed by a psychiatrist. 4) Depression severity as defined by score of <17 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. 5)Adequate visual and auditory acuity to allow neuropsychological testing. 6)Stable regime of psychiatric medications for 1 month prior to insulin test. Exclusion Criteria:1)Diagnosis of possible or probable cognitive impairment. 2)For women only: pregnancy, breastfeeding. 3)Personal history of Type I or Type II diabetes. 4) Unstable cardiovascular disease or other major medical condition, or history of myocardial infarction within the previous year. 5)Significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressures > 100). 6) Current drug or alcohol abuse. 7)History of neurological disorder, e.g. multiple sclerosis, stroke etc. 8)Use of any drug that may significantly affect psychometric testing, or the insulin testing

Additional Information

Official title Insulin Resistance in Patients With Major Depression
Principal investigator Dr Natalie Rasgon
Trial information was received from ClinicalTrials.gov and was last updated in May 2014.
Information provided to ClinicalTrials.gov by Stanford University.