Phase 3
N=57
Aspirin in Young Psychotic Patients
Psychosis · Acute Psychosis · Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT02685748 ↗Enrolled (actual)
57
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: Primary: Neurological Soft Signs — 6.96; 7.04 score on a scale — p=0.863
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Aspirin (Drug); Placebo (Drug); Pantoprazole (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clinic for Psychiatric Disorders, Dr Laza Lazarevic
- Primary completion
- Dec 2019
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 |
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.
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
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.