Insulin Resistance in Patients With Major Depression

NCT01106313 | Completed

• 2 other identifiers: SU-02172010-5003eProtocol 17089
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression; Bipolar Disorder; Mood Disorders; Insulin Resistance; Depressive Disorder, Major; Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• To examine the association between insulin resistance and cognitive performance and clinical course of depression in patients with depression

  1 wk

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women ages 20 to 65 years of age of any ethnic background, with a diagnosis of depression, and whose depressive symptoms are currently in remission

You may qualify if:

• )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.
• \) 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.

You may not qualify if:

• )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.
• )Significant cerebrovascular disease, as evidenced by neurological examination, uncontrolled hypertension (systolic blood pressure \> 170 or diastolic blood pressures \> 100).
• \) 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

Sponsors & Collaborators

• Stanford University: lead
• American Diabetes Association: collaborator

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

Related Publications (1)

• Wroolie TE, Kenna HA, Singh MK, Rasgon NL. Association between insulin resistance and cognition in patients with depressive disorders: exploratory analyses into age-specific effects. J Psychiatr Res. 2015 Jan;60:65-72. doi: 10.1016/j.jpsychires.2014.10.001. Epub 2014 Oct 14.

  PMID: 25455511 DERIVED

Related Links

• Stanford Center for Neuroscience in Women's Health

Biospecimen

Retention: SAMPLES WITH DNA

Optional buffy coat sample

MeSH Terms

Conditions

Depression; Bipolar Disorder; Mood Disorders; Insulin Resistance; Depressive Disorder, Major; Depressive Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• Dr Natalie Rasgon

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 16, 2010
• First Posted: April 19, 2010
• Study Start: July 1, 2009
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: October 4, 2017

Record last verified: 2017-10

Locations

US (1)