Phase 3 Completed N=57 Randomized Quadruple-blind Treatment

Aspirin in Young Psychotic Patients

Psychosis · Acute Psychosis · Schizophrenia

Source: ClinicalTrials.gov NCT02685748 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2024

Primary outcomePrimary: Neurological Soft Signs — 6.96; 7.04 score on a scale — p=0.863

◆ Published Evidence

No publication linked

No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.

Summary

In this double blind randomized clinical trial the investigators are going to exam influence of adjuvant Aspirin therapy on soft neurological signs (Heidelberg scale), positive and negative symptoms (PANSS), cytokine profile and inflammatory factors, as well as on cognition (MoCA) in young psychotic patients.

Outcome Measures

Outcome	Result	p-value
PRIMARY Neurological Soft Signs	6.96; 7.04	0.863
PRIMARY Psychopathology Symptoms Assessed by PANSS	67.70; 71.32	0.133
SECONDARY Cognitive Assessment by MoCA Scale	27.63; 28.32	1.607
SECONDARY Marker of Inflammation: C-reactive Protein (CRP)	3.080; 4.363	0.468
SECONDARY Marker of Inflammation- White Blood Cells (WBC)	6.252; 6.303	0.899
SECONDARY Cytokine Profile- Th1- Interferon Gamma (IFN-γ)	92.557; 85.507	0.305
SECONDARY Cytokine Profile- Th2-Interleukin 4 (IL4)	620.340; 460.042	0.320
SECONDARY Cytokine Profile- Type 17- Interleukin 17 (IL17)	11.760; 13.255	0.676

Eligibility Criteria

Inclusion Criteria

18 to 28 years of life
diagnostic categories from F 20 to F 29, according to ICD 10 (International Classification of Diseases Version 10) criteria
duration of illness ≤ 7 years

Exclusion Criteria

Substance abuse
Primary cognitive impairment
Contraindications and special caution for acetylsalicylic acid and pantoprazole: hypersensitivity to aspirin and other NSAIDs or pantoprazole, ulcers, gastritis, pregnancy, haemophilia, bleeding disorders, gout, asthma, COPD (Chronic obstructive pulmonary disease), bronchospasm induced by NSAIDs, angioedema, urticaria, haemolytic anaemia, use of warfarin or methotrexate, diabetes, reduced function of liver and/or kidney, heart failure, surgical/dental intervention, interactions with certain psychotropic drugs

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02685748). 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. Informational only — not medical advice.