Insulin Resistance in Patients With Major Depression
This trial is active, not recruiting.
|Conditions||depression, bipolar disorder, mood disorders, insulin resistance, depressive disorder, major, depressive disorder|
|Collaborator||American Diabetes Association|
|Start date||July 2009|
|End date||January 2016|
|Trial size||90 participants|
|Trial identifier||NCT01106313, SU-02172010-5003, eProtocol 17089|
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.
|Observational model||case control|
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
To examine the association between insulin resistance and cognitive performance and clinical course of depression in patients with depression
time frame: 1 wk
Male or female participants from 20 years up to 65 years old.
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
|Official title||Insulin Resistance in Patients With Major Depression|
|Principal investigator||Dr Natalie Rasgon|
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