Clinical trial NCT01106313: Insulin Resistance in Patients With Major Depression
Official title: Insulin Resistance in Patients With Major Depression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Bipolar Disorder
Mood Disorders
Insulin Resistance
Depressive Disorder, Major
Depressive Disorder
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: American Diabetes Association
First posted: 2010-04-19
Enrollment: 57
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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

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.


Eligibility 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

Primary outcomes:
measure: 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
timeFrame: Within 3 hours of initial infusion
Secondary outcomes:
measure: To examine the association between insulin resistance and cognitive performance and clinical course of depression in patients with depression
timeFrame: 1 wk
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Dr Natalie Rasgon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.