Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis

Study Overview
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Brief Summary
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The primary objective of this study is to determine whether aspirin is effective in alleviating symptoms of the clinical high risk (CHR) syndrome for psychosis. The investigators further aim to determine whether it may delay or prevent the onset of psychosis in those currently experiencing CHR symptoms. As secondary measures the investigators aim to collect laboratory studies of inflammation markers and genetic samples to determine whether certain genetic profiles correlate with risk for psychosis, or response to aspirin treatment.

Detailed Description
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Patients will be randomly assigned to either active treatment (aspirin) or placebo.

Official Title
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Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis

Conditions
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Clinical High Risk for Psychosis

Intervention / Treatment
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* Drug: Aspirin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 - 35 Must have a SIPS interview CHR subjects must meet at least one of 3 CHR syndromes defined by SIPS Must demonstrate adequate decisional capacity Exclusion Criteria: Under age of 19 Have pre-existing gastrointestinal disease, heart disease Have kidney disease Taking non-steroidal anti-inflammatory medications Hypersensitive to NSAID (non-steroidal anti-inflammatory medications) Have coexisting unstable major medical illness Are pregnant or breastfeeding Consume more than 2 drinks of alcohol per day Have a blood clotting disorder Are taking ACE inhibitors, acetazolamide, anticoagulants, anticonvulsants, beta blockers, diuretics, methotrexate, oral hypoglycemic or uricosuric agents Have a history of substance abuse in past three moths or dependence in past 6 months

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1000 mg/day aspirin<br>1000 mg/day aspirin | Drug: Aspirin<br>* 1000 mg/day of aspirin 1000 mg/day of sugar pill<br>|
| Placebo Comparator: sugar pill<br>sugar pill | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Scale of Prodromal Symptoms (SOPS) | Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo | 2 weeks | 
| Scale of Prodromal Symptoms (SOPS) | Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo | 4 weeks | 
| Scale of Prodromal Symptoms (SOPS) | Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo | 8 weeks | 
| Scale of Prodromal Symptoms (SOPS) | Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo | 12 weeks |