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Brain Function in Depression and Insulin Resistance

Sponsor
University of Pittsburgh (Other)
Overall Status
Terminated
CT.gov ID
NCT02889211
Collaborator
(none)
42
Enrollment
1
Location
4
Arms
16
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to help researchers learn about how the brain responds to rewards. This study is interested in seeing how these responses differ between people who are more and less responsive to insulin in their body, and people with and without depression.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Gambling Task
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
42 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Brain Function in Depression and Insulin Resistance
Study Start Date :
Aug 1, 2016
Actual Primary Completion Date :
Dec 1, 2017
Actual Study Completion Date :
Dec 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Metabolically Healthy - Non-depressed

Overweight individuals without metabolic syndrome and free of psychiatric illness

Behavioral: Gambling Task
Experimental: Metabolically Healthy - Depressed

Overweight individuals without metabolic syndrome and with active major depression

Behavioral: Gambling Task
Experimental: Insulin Resistant - Depressed

Overweight individuals with metabolic syndrome and active major depression

Behavioral: Gambling Task
Experimental: Insulin Resistant - Non-depressed

Overweight individuals with metabolic syndrome and free of psychiatric illness

Behavioral: Gambling Task

Outcome Measures

Primary Outcome Measures

  1. fMRI BOLD Response in Striatal Regions [During Gambling Task in fMRI Scanner]

    The investigators will monitor the blood oxygen level dependent response using fMRI and compare activation during "win" trials vs. "loss" trials

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

Body Mass Index 24-34.9

HEALTHY CONTROLS HOMA-IR (fasting (glucose x insulin)/405) < 1.8

Not more than one of the following:

  • Waist circumference > 40 inches (men) or > 35 inches (women)

  • Triglycerides > 150 mg/dL

  • HDL < 40 mg/dL (men) or < 50 mg/dL (women)

  • Blood pressure > 135/85

  • Fasting glucose > 100 mg/dL

INSULIN RESISTANT HOMA-IR > 2.0

And at least three of the following:

  • Waist circumference > 40 inches (men) or >35 inches (women)

  • Triglycerides > 150 mg/dL

  • HDL < 40 mg/dL (men) or <50 mg/dL (women)

  • Blood pressure > 135/85

  • Fasting glucose > 100 mg/dL

MAJOR DEPRESSION, METABOLICALLY HEALTHY Meets criteria for MDD during SCID-5 evaluation HOMA-IR < 1.8

Not more than one of the following:

  • Waist circumference > 40 inches (men) or >35 inches (women)

  • Triglycerides > 150 mg/dL

  • HDL < 40 mg/dL (men) or <50 mg/dL (women)

  • Blood pressure > 135/85

  • Fasting glucose > 100 mg/dL

MAJOR DEPRESSION, INSULIN RESISTANT Meets criteria for MDD during SCID-5 evaluation HOMA-IR

2.0

And at least three of the following:

  • Waist circumference > 40 inches (men) or >35 inches (women)

  • Triglycerides > 150 mg/dL

  • HDL < 40 mg/dL (men) or <50 mg/dL (women)

  • Blood pressure > 135/85

  • Fasting glucose > 100 mg/dL

Exclusion Criteria:
    • History of mania or psychosis

  • Current suicidal ideation

  • Alcohol or substance abuse including cannabis use (current or in the last three months)

  • Early onset dementia of any etiology

  • Medical conditions with known significant effects on mood (e.g. Stroke or current hypothyroid state)

  • Unstable medical illnesses (e.g. Delirium, uncontrolled DM, uncontrolled cardiovascular illness)

  • Use of high doses of benzodiazepines (> 2mg lorazepam/day equivalent)

  • Given the high comorbidity (80%) between MDD and anxiety disorders, participants with comorbid anxiety disorders will be included in the study as long as the clinical presentation suggests that depression precedes the onset of anxiety

  • Current or lifetime history of cancer, a chronic kidney or liver condition, type I or II diabetes

  • Current or lifetime use of glucocorticoid medications for >1 month

  • Previous cerebrovascular accident or trauma involving loss of consciousness

  • Previous neurosurgery or history of a neurological condition

  • Pregnancy (females)

  • Claustrophobia

  • Ferrous metallic implants or any surgically placed medical device not cleared for safety at 3Tesla MRI strength

  • Positive Hepatitis C serology or other known viral infections that may induce insulin resistance

  • Peripheral vascular disease

  • Liver, kidney, or active blood disease

  • Peripheral neuropathy

  • Fasting glucose > 126 mg/dL

  • Currently taking any medications that can alter glucose homeostasis (steroids, glucocorticoids, nicotinic acid)

  • Currently taking thiazolidinediones or insulin

  • Females currently on hormone replacement therapy (HRT) less than 6 months

  • Being left handed

  • Use of antidepressant medication within the past two weeks (six weeks fluoxetine)

  • Suicide risk

  • Current use of stimulants, antipsychotic medications, mood stabilizers, cognitive enhancers, statins, glucocorticoids, steroids, nicotinic acid, thiazolidinediones, insulin, metformin, any diabetes medications (e.g. gliptins), HIV medications.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Western Psychiatric Institute and Clinic at University of Pittsburgh Pittsburgh Pennsylvania United States 15213

Sponsors and Collaborators

  • University of Pittsburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
John Patrick Ryan, Assistant Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT02889211
Other Study ID Numbers:
  • 16060315
First Posted:
Sep 5, 2016
Last Update Posted:
Dec 5, 2017
Last Verified:
Dec 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Insulin Resistance
Depression
Depressive Disorder

Study Results

No Results Posted as of Dec 5, 2017