Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis
Overview
- Phase
- Early Phase 1
- Intervention
- Aspirin
- Conditions
- Clinical High Risk for Psychosis
- Sponsor
- Yale University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Scale of Prodromal Symptoms (SOPS)
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
Brief Summary
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
Patients will be randomly assigned to either active treatment (aspirin) or placebo.
Investigators
Eligibility Criteria
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
Arms & Interventions
1000 mg/day aspirin
1000 mg/day aspirin
Intervention: Aspirin
sugar pill
sugar pill
Intervention: Placebo
Outcomes
Primary Outcomes
Scale of Prodromal Symptoms (SOPS)
Time Frame: 12 weeks
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo