NCT02889211

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Aug 2016

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

August 23, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 5, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

1.3 years

First QC Date

August 23, 2016

Last Update Submit

December 2, 2017

Conditions

DepressionInsulin Resistance

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

Metabolically Healthy - Non-depressed

ACTIVE COMPARATOR

Overweight individuals without metabolic syndrome and free of psychiatric illness

Behavioral: Gambling Task

Metabolically Healthy - Depressed

EXPERIMENTAL

Overweight individuals without metabolic syndrome and with active major depression

Behavioral: Gambling Task

Insulin Resistant - Depressed

EXPERIMENTAL

Overweight individuals with metabolic syndrome and active major depression

Behavioral: Gambling Task

Insulin Resistant - Non-depressed

EXPERIMENTAL

Overweight individuals with metabolic syndrome and free of psychiatric illness

Behavioral: Gambling Task

Interventions

Gambling TaskBEHAVIORAL
Insulin Resistant - DepressedInsulin Resistant - Non-depressedMetabolically Healthy - DepressedMetabolically Healthy - Non-depressed

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • +14 more criteria

You may not qualify if:

  • \- 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
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic at University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

DepressionInsulin Resistance

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 23, 2016

First Posted

September 5, 2016

Study Start

August 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 1, 2017

Last Updated

December 5, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)