Impact of Inflammation on Reward Circuits, Motivational Deficits and Negative Symptoms in Schizophrenia
Completed · Not applicable
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT03818516
- Run by
- Emory University
- People needed
- 12
- Starts
- 2020-08-31
- Expected to finish
- 2022-03-01
- Last updated by the study team
- 2024-05-02
Who can join
Age: 18 and older, up to 59. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Emory University Department of Psychiatry and Behavioral Sciences — Atlanta, Georgia, United States
- Grady Health System (non-CRN), Grady Health System (CRN), Ponce Center — Atlanta, Georgia, United States
- Emory Clinic, Emory University Hospital — Atlanta, Georgia, United States
- Emory University Clinical Research Network — Atlanta, Georgia, United States
- Emory University — Atlanta, Georgia, United States
- Emory Universtiy — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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