Brain Function in Depression and Insulin Resistance

Depression Clinical Trial

Official title:

Brain Function in Depression and Insulin Resistance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02889211
• Other study ID #: 16060315
• Status: Terminated
• Phase: N/A
• First received: August 23, 2016
• Last updated: December 2, 2017
• Start date: August 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Insulin Resistance

Intervention

Behavioral:
• Gambling Task

Locations

Country	Name	City	State
United States	Western Psychiatric Institute and Clinic at University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI BOLD Response in Striatal Regions	The investigators will monitor the blood oxygen level dependent response using fMRI and compare activation during "win" trials vs. "loss" trials	During Gambling Task in fMRI Scanner