Status:
COMPLETED
Impact of Inflammation on Reward Circuits, Motivational Deficits and Negative Symptoms in Schizophrenia
Lead Sponsor:
Emory University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Schizophrenia
Eligibility:
All Genders
18-59 years
Phase:
NA
Brief Summary
This study will recruit persons with schizophrenia or schizoaffective disorder and will use an oral glucose tolerance test to test the hypothesis that insulin resistance drives inflammation.
Detailed Description
Schizophrenia is a severe mental illness that affects 1% of the population, but accounts for over $60 billion in costs to the national healthcare system. Negative symptoms of schizophrenia, including ...
Eligibility Criteria
Inclusion
- Willing and able to give written informed consent
- A primary diagnosis of schizophrenia, per the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5), or schizoaffective disorder as diagnosed by the Mini International Neuropsychiatric Interview (MINI) 7.0
- Mini Mental Status Examination Score ≥24
- Brief Negative Symptom Scale Score ≥25
- No psychotropic medication changes for one month prior to study enrollment; may be taking other psychotropic non-antipsychotic medications (i.e., antidepressants, mood stabilizers, benzodiazepines)
Exclusion
- Evidence of untreated or poorly controlled endocrine, thyroid, cardiovascular, hematological, renal, neurological disease, hepatitis B or C or HIV
- Current HbA1C ≥ 8.5%
- Prior treatment with antiviral or immunomodulatory drugs, including corticosteroids within six months of study entry
- Current treatment with antibiotics
- Primary diagnosis of major depressive disorder or bipolar disorder
- Active abuse of alcohol or illicit/prescription drugs within the past 6 months including a urine toxicology screen positive for drugs of abuse (patients may still be included with a positive tetrahydrocannabinol (THC) result at the discretion of the PI)
- Predominant left-handedness excluded for portions of the MRI scan
- Wide Range Achievement Test-3 Reading Scale (WRAT-3) score indicating less than 8th grade reading level, unless otherwise approved by the PI or PI's designee
- Any other condition which in the opinion of the investigator would make the patient unsuitable for enrollment, or could interfere with participating in or completing the protocol
- History of central nervous system trauma or active seizure disorder requiring medication
- Positive pregnancy test
- Presence of metal in the body (excludes from MRI scan only)
- Active suicidal ideation as determined by the PI and/or study staff
- Diagnosis of diabetes mellitus
Key Trial Info
Start Date :
August 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT03818516
Start Date
August 31 2020
End Date
March 1 2022
Last Update
May 2 2024
Active Locations (6)
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1
Emory University Department of Psychiatry and Behavioral Sciences
Atlanta, Georgia, United States, 30030
2
Grady Health System (non-CRN), Grady Health System (CRN), Ponce Center
Atlanta, Georgia, United States, 30303
3
Emory Clinic, Emory University Hospital
Atlanta, Georgia, United States, 30322
4
Emory University Clinical Research Network
Atlanta, Georgia, United States, 30322