NCT03818516

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

Completed NA Results posted Last updated 2 May 2024

What this trial tests

NA trial testing Oral Glucose Tolerance Test (OGTT) in Schizophrenia in 12 participants. Completed in 1 March 2022.

Timeline

31 August 2020

Primary endpoint
1 March 2022

1 March 2022

Quick facts

Lead sponsor	Emory University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	basic science
Enrollment	12
Start date	31 August 2020
Primary completion	1 March 2022
Estimated completion	1 March 2022
Sites	6 locations across United States

Drugs / interventions tested

• Oral Glucose Tolerance Test (OGTT) — full drug profile →

Conditions studied

• Schizophrenia — all drugs for Schizophrenia →

Sponsor

Emory University

Who can join

Adults 18 to 59, any sex, with Schizophrenia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Effort-Expenditure for Rewards Task (EEfRT) Score Primary · Baseline, Hour 1

EEfRT is a multitrial game task assessing motivation in which participants choose between 2 different task difficulty levels to obtain monetary rewards. For all trials, participants make repeated manual button presses which raises the level of a virtual ''bar'' viewed onscreen by the participant. Participants are eligible to win the money allotted for each trial if they raise the bar to the ''top''. Each trial presents subjects with a choice between 'high effort' and 'low effort' tasks that require different amounts of button pressing. Reward magnitudes for the high-effort task vary between am

Baseline

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	0.268	± 0.217

Hour 1

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	0.189	± 0.153

Finger Tapping Task (FTT) Score Secondary · Baseline, Hour 1

The Finger Tapping Task (FTT) uses a specially adapted tapper that the subject is asked to tap as fast as possible. The subject is given 5 consecutive 10-second trials for the preferred and non-preferred hands.The FTT is design to assess subtle motor impairment and found to be altered in subjects with basal ganglia disorders and lesions. The finger tapping score is the mean number of taps of 5 trials and is computed for each hand.

Right Hand Baseline

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	44.22	± 6.74

Right Hand- Hour 1

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	42.68	± 11.44

Left hand Baseline

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	39.98	± 10.91

Left hand- Hour 1

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	42.01	± 6.40

Trail Making Test Part A (TMT-A) Score Secondary · Baseline, Hour 1

The Trail Making Test-A is a timed task that provides information on motor function and speed of processing. In Part A of the TMT participants connect circles labeled with numbers, in ascending order. The score is the amount of time it takes for the participant to complete the task. The average time it takes to complete the task is 29 seconds and times longer than 78 seconds suggest a deficiency.

Baseline

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	38.86	± 15.44

Hour 1

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	37.02	± 16.12

Digit Symbol Substitution Task (DSST) Score Secondary · Baseline, Hour 1

The DSST is a subtest of the Wechsler Adult Intelligence Scale and involves graphimotor speed, visual scanning and memory, with about half of the variance being accounted for by graphimotor speed, a third by visual scanning and 4-5% by memory. Performance on the Digit Symbol Test has been found to correlate with subcortical (caudate) atrophy in disorders involving the basal ganglia. Respondents match symbols to numbers using a key presented at the top of the test page. The score is the number of correctly entered symbols in the given time period and higher scores indicate better performance.

Baseline

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	60.55	± 20.28

Hour 1

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	55.09	± 20.98

Profile of Mood States (POMS) Brief Score Secondary · Baseline, Hour 1

The POMS is a 30-item rating scale designed to measure mood states across short periods. The POMS assess six mood factors: Tension-Anxiety, Depression-Dejection, Anger-Hostility, Vigor-Activity, Fatigue-Inertia, and Confusion-Bewilderment. Each item is rated on a 5-point scale where 0 = not at all and 4 = extremely. Total scores range from 0 to 120 and lower scores indicate a better state of mood.

Baseline

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	37.50	± 37.48

1 hour post

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	20.27	± 12.36

Fasting Blood Glucose Secondary · Baseline, Hours 1, 2, and 3

Fasting blood glucose will be assessed to determine the impact of insulin resistance on inflammatory markers.

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	94.27	± 18.78

Fasting Blood Insulin Secondary · Baseline, Hours 1, 2, and 3

Fasting blood insulin will be assessed to determine the impact of insulin resistance on inflammatory markers.

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	12.9	± 10.05

Plasma C-reactive Protein (CRP) Levels Secondary · Baseline, Hours 1, 2, and 3

Plasma CRP will be assessed to determine the impact of insulin resistance on inflammatory markers.

Group	Value	95% CI
Oral Glucose Tolerance Test (OGTT)	3.83	± 4.67

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.