Insulin Resistance in Patients With Major Depression

Depression Clinical Trial

Official title:

Insulin Resistance in Patients With Major Depression

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01106313
• Other study ID #: SU-02172010-5003
• Secondary ID: eProtocol 17089
• Status: Completed
• Phase: N/A
• First received: April 16, 2010
• Last updated: October 3, 2017
• Start date: July 2009
• Est. completion date: January 2016

Study information

• Verified date: October 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bipolar Disorder
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Disease
• Insulin Resistance
• Mood Disorders

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	American Diabetes Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		Within 3 hours of initial infusion
Secondary	To examine the association between insulin resistance and cognitive performance and clinical course of depression in patients with depression		1 wk

External Links

•   Stanford Center for Neuroscience in Women's Health