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N/A N=12 Basic Science

Impact of Inflammation on Reward Circuits, Motivational Deficits and Negative Symptoms in Schizophrenia

Schizophrenia

Enrolled (actual)
12
Serious AEs
0.0%
Results posted
May 2024
Primary outcome: Primary: Effort-Expenditure for Rewards Task (EEfRT) Score — 0.268; 0.189 proportion of hard-task choices

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Oral Glucose Tolerance Test (OGTT) (Other)
Age
Adult · 18+ yrs
Sex
All
Sponsor
Emory University
Primary completion
Mar 2022

Outcome Measures

OutcomeResultp-value
PRIMARY
Effort-Expenditure for Rewards Task (EEfRT) Score
0.268; 0.189
SECONDARY
Finger Tapping Task (FTT) Score
44.22; 42.68; 39.98; 42.01
SECONDARY
Trail Making Test Part A (TMT-A) Score
38.86; 37.02
SECONDARY
Digit Symbol Substitution Task (DSST) Score
60.55; 55.09
SECONDARY
Profile of Mood States (POMS) Brief Score
37.50; 20.27

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.

Eligibility Criteria

Inclusion Criteria

  • 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 Criteria

  • 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03818516). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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