Trial Outcomes & Findings for Aspirin in Young Psychotic Patients (NCT NCT02685748)
NCT ID: NCT02685748
Last Updated: 2024-09-23
Results Overview
Neurological soft signs were assessed with the Heidelberg Scale which consists of five subscales (motor coordination, integrative functions, complex motor tasks, orientation, hard signs) comprising 16 items (gait, tandem walking, right/left orientation, arm holding test, finger to nose test, Ozeretzki's test, diadochokinesis, pronation-supination, finger to thumb opposition, mirror movements, two point discrimination, graphaesthesia, face- hand test, stereognosis, fist- edge- palm test, speech and articulation). Ratings are given on a 0-3 point scale (no/slight/moderate/marked abnormality, respectively) for all items except for tandem walking (0-1 point scale; 0: no/slight, 1: moderate/marked abnormality). Scale ranges: minimum- 0 (better outcome), maximum 46 points (worse outcome).
COMPLETED
PHASE2/PHASE3
60 participants
Comparison of total scores on Heidelberg scale between groups (aspirin and placebo group) after 6 weeks of treatment.
2024-09-23
Participant Flow
60 patients enrolled, 57 randomized
Participant milestones
| Measure |
Aspirin
Aspirin 1000 mg/per day, orally, two doses
Pantoprazole 40 mg/per day, orally, in two doses for gastric protection
|
Placebo
placebo- two times a day two pills orally
|
|---|---|---|
|
Overall Study
STARTED
|
28
|
29
|
|
Overall Study
COMPLETED
|
25
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Aspirin
Aspirin 1000 mg/per day, orally, two doses
Pantoprazole 40 mg/per day, orally, in two doses for gastric protection
|
Placebo
placebo- two times a day two pills orally
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
Baseline Characteristics
Aspirin in Young Psychotic Patients
Baseline characteristics by cohort
| Measure |
Aspirin
n=28 Participants
Aspirin 1000 mg/pd per os in two doses
Pantoprazole 40 mg/pd per os in two doses for gastric protection
|
Placebo
n=29 Participants
placebo- 2 times a day two pills
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
33 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
57 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Comparison of total scores on Heidelberg scale between groups (aspirin and placebo group) after 6 weeks of treatment.Neurological soft signs were assessed with the Heidelberg Scale which consists of five subscales (motor coordination, integrative functions, complex motor tasks, orientation, hard signs) comprising 16 items (gait, tandem walking, right/left orientation, arm holding test, finger to nose test, Ozeretzki's test, diadochokinesis, pronation-supination, finger to thumb opposition, mirror movements, two point discrimination, graphaesthesia, face- hand test, stereognosis, fist- edge- palm test, speech and articulation). Ratings are given on a 0-3 point scale (no/slight/moderate/marked abnormality, respectively) for all items except for tandem walking (0-1 point scale; 0: no/slight, 1: moderate/marked abnormality). Scale ranges: minimum- 0 (better outcome), maximum 46 points (worse outcome).
Outcome measures
| Measure |
Aspirin
n=25 Participants
Aspirin 1000 mg/ per day, orally, in two doses
Pantoprazole 40 mg/ per day, orally, in two doses for gastric protection
Aspirin: 1000 mg/ per day, orally, in two doses
Pantoprazole: Pantoprazole 40 mg/ per day, orally, in two doses, for gastric protection
|
Placebo
n=27 Participants
Two pills in the morning and two in the evening
All pills (aspirin, pantoprazole an placebo) will be the same looking- in the same capsules.
Placebo: two pills twice a day (instead of aspirin and pantoprazole)
|
|---|---|---|
|
Neurological Soft Signs
|
6.96 score on a scale
Standard Deviation 1.670
|
7.04 score on a scale
Standard Deviation 1.537
|
PRIMARY outcome
Timeframe: Comparison of total scores on PANSS (aspirin and placebo group) after 6 weeks of treatment.The Positive and Negative Syndrome Scale (PANSS) is 30 item scale used to evaluate the presence, absence and severity of Positive, Negative and General Psychopathology symptoms of schizophrenia. Ratings are given on a 1-7 point scale (1- absent, 2- minimal, 3- mild, 4- moderate, 5- moderate severe, 6- severe, 7- extreme). Patient can not score lower than 30 for the total PANSS score. Maximum score is 210. Higher scores mean a worse outcome.
Outcome measures
| Measure |
Aspirin
n=25 Participants
Aspirin 1000 mg/ per day, orally, in two doses
Pantoprazole 40 mg/ per day, orally, in two doses for gastric protection
Aspirin: 1000 mg/ per day, orally, in two doses
Pantoprazole: Pantoprazole 40 mg/ per day, orally, in two doses, for gastric protection
|
Placebo
n=27 Participants
Two pills in the morning and two in the evening
All pills (aspirin, pantoprazole an placebo) will be the same looking- in the same capsules.
Placebo: two pills twice a day (instead of aspirin and pantoprazole)
|
|---|---|---|
|
Psychopathology Symptoms Assessed by PANSS
|
67.70 score on a scale
Standard Deviation 10.227
|
71.32 score on a scale
Standard Deviation 6.549
|
SECONDARY outcome
Timeframe: Comparison of total scores on MoCA scale (aspirin and placebo group) after 6 weeks of treatment.The Montreal Cognitive Assessment (MoCA) is a test used to detect cognitive decline. The MoCA test examines seven domains (executive/visuospatial function, naming, attention, language, abstraction, recall, and orientation) of cognitive function with a total of 11 questions with a maximum score of 30. A score of 26 or over is considered to be normal. A score of less than 26 indicates cognitive impairment (worse outcome). Minimal score is 0.
Outcome measures
| Measure |
Aspirin
n=25 Participants
Aspirin 1000 mg/ per day, orally, in two doses
Pantoprazole 40 mg/ per day, orally, in two doses for gastric protection
Aspirin: 1000 mg/ per day, orally, in two doses
Pantoprazole: Pantoprazole 40 mg/ per day, orally, in two doses, for gastric protection
|
Placebo
n=27 Participants
Two pills in the morning and two in the evening
All pills (aspirin, pantoprazole an placebo) will be the same looking- in the same capsules.
Placebo: two pills twice a day (instead of aspirin and pantoprazole)
|
|---|---|---|
|
Cognitive Assessment by MoCA Scale
|
27.63 score on a scale
Standard Deviation 1.282
|
28.32 score on a scale
Standard Deviation 1.757
|
SECONDARY outcome
Timeframe: Comparison of CRP levels between groups (aspirin and placebo group) after six weeks of treatment.A C-reactive protein (CRP) test measures the level of C-reactive protein - a protein made by liver and releases in bloodstream in response to inflammation. Levels below 5 milligrams per liter (mg/L) are usually considered normal or free from infections.
Outcome measures
| Measure |
Aspirin
n=25 Participants
Aspirin 1000 mg/ per day, orally, in two doses
Pantoprazole 40 mg/ per day, orally, in two doses for gastric protection
Aspirin: 1000 mg/ per day, orally, in two doses
Pantoprazole: Pantoprazole 40 mg/ per day, orally, in two doses, for gastric protection
|
Placebo
n=27 Participants
Two pills in the morning and two in the evening
All pills (aspirin, pantoprazole an placebo) will be the same looking- in the same capsules.
Placebo: two pills twice a day (instead of aspirin and pantoprazole)
|
|---|---|---|
|
Marker of Inflammation: C-reactive Protein (CRP)
|
3.080 mg/L
Standard Deviation 2.5549
|
4.363 mg/L
Standard Deviation 8.417
|
SECONDARY outcome
Timeframe: Comparison of WBC levels (aspirin and placebo group) after 6 weeks of treatment.A white blood cell (WBC) count is a test that measures the number of white blood cells in blood. A white blood cell count can detect infections within body. The normal white blood cell count ranges between 4,000 and 11,000 cells per microliter.
Outcome measures
| Measure |
Aspirin
n=25 Participants
Aspirin 1000 mg/ per day, orally, in two doses
Pantoprazole 40 mg/ per day, orally, in two doses for gastric protection
Aspirin: 1000 mg/ per day, orally, in two doses
Pantoprazole: Pantoprazole 40 mg/ per day, orally, in two doses, for gastric protection
|
Placebo
n=27 Participants
Two pills in the morning and two in the evening
All pills (aspirin, pantoprazole an placebo) will be the same looking- in the same capsules.
Placebo: two pills twice a day (instead of aspirin and pantoprazole)
|
|---|---|---|
|
Marker of Inflammation- White Blood Cells (WBC)
|
6.252 x 1000 cells per microliter
Standard Deviation 1.528
|
6.303 x 1000 cells per microliter
Standard Deviation 1.405
|
SECONDARY outcome
Timeframe: Comparison of IFN Gamma levels (aspirin and placebo group) after 6 weeks of treatmentChange of Interferon Gamma (IFN-γ) immune response
Outcome measures
| Measure |
Aspirin
n=25 Participants
Aspirin 1000 mg/ per day, orally, in two doses
Pantoprazole 40 mg/ per day, orally, in two doses for gastric protection
Aspirin: 1000 mg/ per day, orally, in two doses
Pantoprazole: Pantoprazole 40 mg/ per day, orally, in two doses, for gastric protection
|
Placebo
n=27 Participants
Two pills in the morning and two in the evening
All pills (aspirin, pantoprazole an placebo) will be the same looking- in the same capsules.
Placebo: two pills twice a day (instead of aspirin and pantoprazole)
|
|---|---|---|
|
Cytokine Profile- Th1- Interferon Gamma (IFN-γ)
|
92.557 pg/l
Standard Deviation 29.696
|
85.507 pg/l
Standard Deviation 18.420
|
SECONDARY outcome
Timeframe: Comparison of IL 4 levels (aspirin and placebo group) after 6 weeks of treatmentPopulation: patients who have completed study
Change of IL4 immune response
Outcome measures
| Measure |
Aspirin
n=25 Participants
Aspirin 1000 mg/ per day, orally, in two doses
Pantoprazole 40 mg/ per day, orally, in two doses for gastric protection
Aspirin: 1000 mg/ per day, orally, in two doses
Pantoprazole: Pantoprazole 40 mg/ per day, orally, in two doses, for gastric protection
|
Placebo
n=27 Participants
Two pills in the morning and two in the evening
All pills (aspirin, pantoprazole an placebo) will be the same looking- in the same capsules.
Placebo: two pills twice a day (instead of aspirin and pantoprazole)
|
|---|---|---|
|
Cytokine Profile- Th2-Interleukin 4 (IL4)
|
620.340 pg/l
Standard Deviation 817.873
|
460.042 pg/l
Standard Deviation 133.44
|
SECONDARY outcome
Timeframe: Comparison of IL 17 levels (aspirin and placebo group) after 6 weeks of treatmentPopulation: patients who have completed study
Change of IL17 immune response
Outcome measures
| Measure |
Aspirin
n=25 Participants
Aspirin 1000 mg/ per day, orally, in two doses
Pantoprazole 40 mg/ per day, orally, in two doses for gastric protection
Aspirin: 1000 mg/ per day, orally, in two doses
Pantoprazole: Pantoprazole 40 mg/ per day, orally, in two doses, for gastric protection
|
Placebo
n=27 Participants
Two pills in the morning and two in the evening
All pills (aspirin, pantoprazole an placebo) will be the same looking- in the same capsules.
Placebo: two pills twice a day (instead of aspirin and pantoprazole)
|
|---|---|---|
|
Cytokine Profile- Type 17- Interleukin 17 (IL17)
|
11.760 pg/l
Standard Deviation 14.691
|
13.255 pg/l
Standard Deviation 10.809
|
Adverse Events
Aspirin
Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Pavicevic Dragana
CPD Dr Laza Lazarevic, Belgrade, Serbia
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place