TerminatedNot Applicable

Risks for Insulin Resistance and Metabolic Syndrome Between Major Depressive Disorder (MDD) or MDD With Psychotic Features

Stopped: PI left Massachusetts General Hospital Inpatient service

United States14 participantsStarted 2011-01

Plain-language summary

Studies have shown that people with certain disorders have an increased risk of developing a condition called Metabolic Syndrome (MS). In this study, the investigators want to learn more about MS among people staying in the hospital for treatment of Major Depressive Disorder (MDD) and also Major Depressive Disorder with Psychotic Features (MDpsy). The investigators also want to learn more about a stress hormone called cortisol that is made in the body. Those who take part in this study will answer some questionnaires, be given some psychiatric interviews, and have some blood taken along with a urine sample. The investigators believe that patients in the hospital with MDpsy will have higher baseline rates of MS factors, cortisol levels, dexamethasone non-suppression, and insulin resistance, compared with MDD alone.

Who can participate

Age range18 Years – 85 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Capable of giving informed consent * DSM-IV TR diagnosis of Major Depressive Disorder with (MDpsy) or without (MDD) Psychotic Features * Age between 18 and 85, inclusive * Pre-existing Hyperlipidemia, Hypertension, and Diabetes must be stable with laboratory and clinical results within acceptable range; with or without medication for three months prior to admission Exclusion Criteria: * DSM-IV TR diagnosis of: schizophrenia, schizoaffective disorder, delusional disorder, bipolar disorder, organic mental disorder, substance use dependence including alcohol, that has been active within the past 6 months, acute bereavement, and psychotic disorder not elsewhere classified * Subjects that meet criteria for substance or alcohol dependence more recently than three months prior to entering the study * Subjects that meet criteria for substance or alcohol abuse more recently than four weeks prior to entering the study * Pregnancy * Unstable or inadequately treated pre-existing hyperlipidemia, hypertension, and diabetes * Subjects who are involuntarily committed.

What they're measuring

The primary measure is any change in fasting insulin from admission to discharge while subjects are inpatient.

Timeframe: Measure fasting insulin at two timepoints; to determine change from baseline (admission) and discharge

Trial details

NCT IDNCT01310140

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2012-09