Insulin Resistance in Patients With Major Depression

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
American Diabetes Association
Information provided by (Responsible Party):
Natalie Rasgon, Stanford University
ClinicalTrials.gov Identifier:
NCT01106313
First received: April 16, 2010
Last updated: May 14, 2014
Last verified: June 2012
  Purpose

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.


Condition
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 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01106313

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

Additional Information:
No publications provided

Responsible Party: Natalie Rasgon, Principal Investigator, Stanford University
ClinicalTrials.gov 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
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Bipolar Disorder
Depression
Depressive Disorder
Insulin Resistance
Depressive Disorder, Major
Mood Disorders
Affective Disorders, Psychotic
Mental Disorders
Behavioral Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 28, 2014