DepressionNCT02889211
Brain Function in Depression and Insulin Resistance
A study testing Gambling Task in people with Depression and Insulin Resistance, run by University of Pittsburgh at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression, Insulin Resistance
- What is being tested?
- Gambling Task
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- - 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)
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic at University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
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.
- Conditions
- Depression, Insulin Resistance
- Being tested
- Gambling Task
- Medical subject headings
- Depression, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gambling TaskBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Metabolically Healthy - Non-depressed | Active comparator | Overweight individuals without metabolic syndrome and free of psychiatric illness Receives: Behavioral: Gambling Task |
| Metabolically Healthy - Depressed | Experimental | Overweight individuals without metabolic syndrome and with active major depression Receives: Behavioral: Gambling Task |
| Insulin Resistant - Depressed | Experimental | Overweight individuals with metabolic syndrome and active major depression Receives: Behavioral: Gambling Task |
| Insulin Resistant - Non-depressed | Experimental | Overweight individuals with metabolic syndrome and free of psychiatric illness Receives: Behavioral: Gambling Task |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During Gambling Task in fMRI Scanner
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2016 (estimated)
- Study startAug 2016
- Primary completionDec 2017
- Study completionDec 2017
Why it stopped: Principal Investigator Left University
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, John Patrick Ryan, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02889211
- Sponsor's protocol ID
- 16060315
- Status last verified
- Dec 2017
- First submitted
- 23 Aug 2016
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Function in Depression and Insulin Resistance
- ClinicalTrials.gov ID
- NCT02889211
- Acronym / sponsor ID
- 16060315
- Conditions
- Depression, Insulin Resistance
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Principal Investigator Left University
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 5 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Metabolically Healthy - Non-depressed | Active comparator | Behavioral: Gambling TaskOverweight individuals without metabolic syndrome and free of psychiatric illness |
| Metabolically Healthy - Depressed | Experimental | Behavioral: Gambling TaskOverweight individuals without metabolic syndrome and with active major depression |
| Insulin Resistant - Depressed | Experimental | Behavioral: Gambling TaskOverweight individuals with metabolic syndrome and active major depression |
| Insulin Resistant - Non-depressed | Experimental | Behavioral: Gambling TaskOverweight individuals with metabolic syndrome and free of psychiatric illness |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (29 listed)
- Body Mass Index 24-34.9
- HEALTHY CONTROLS HOMA-IR (fasting (glucose x insulin)/405) < 1.8
- Waist circumference > 40 inches (men) or > 35 inches (women)
- Triglycerides > 150 mg/dL
- HDL < 40 mg/dL (men) or < 50 mg/dL (women)
Key exclusion criteria (27 listed)
- - 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gambling Task | Behavioural | Insulin Resistant - Depressed, Insulin Resistant - Non-depressed, Metabolically Healthy - Depressed, Metabolically Healthy - Non-depressed |
Primary outcome
fMRI BOLD Response in Striatal Regions
Time frame: 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
Results and safety
The study was stopped early (reason given: Principal Investigator Left University). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gambling Task in people with Depression and Insulin Resistance, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 29 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Principal Investigator Left University). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
fMRI BOLD Response in Striatal Regions (time frame: During Gambling Task in fMRI Scanner). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2017.