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Insulin Resistance in Patients With Major Depression

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Natalie Rasgon, Stanford University.
Recruitment status was:  Active, not recruiting
American Diabetes Association
Information provided by (Responsible Party):
Natalie Rasgon, Stanford University Identifier:
First received: April 16, 2010
Last updated: May 14, 2014
Last verified: June 2012
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.

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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Insulin Resistance in Patients With Major Depression

Resource links provided by NLM:

Further study details as provided by Natalie Rasgon, Stanford University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • To examine the association between insulin resistance and cognitive performance and clinical course of depression in patients with depression [ Time Frame: 1 wk ]

Biospecimen Retention:   Samples With DNA
Optional buffy coat sample

Estimated Enrollment: 90
Study Start Date: July 2009
Estimated Study Completion Date: January 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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

  Contacts and Locations
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Please refer to this study by its identifier: NCT01106313

United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
American Diabetes Association
Principal Investigator: Dr Natalie Rasgon Stanford University
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Natalie Rasgon, Principal Investigator, Stanford University Identifier: NCT01106313     History of Changes
Other Study ID Numbers: SU-02172010-5003
eProtocol 17089
Study First Received: April 16, 2010
Last Updated: May 14, 2014

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Insulin Resistance
Bipolar Disorder
Mood Disorders
Pathologic Processes
Behavioral Symptoms
Mental Disorders
Glucose Metabolism Disorders
Metabolic Diseases
Bipolar and Related Disorders processed this record on September 21, 2017