Insulin Resistance in Patients With Major Depression
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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 |
- 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 ]
- 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 2013 |
| Estimated Primary Completion Date: | January 2013 (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 |
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| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| 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: | June 5, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Depression Depressive Disorder Depressive Disorder, Major Bipolar Disorder Insulin Resistance Mood Disorders |
Affective Disorders, Psychotic Mental Disorders Behavioral Symptoms Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
ClinicalTrials.gov processed this record on May 23, 2013