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

Early Phase 1

Terminated

• Conditions: Clinical High Risk for Psychosis
• Interventions: Drug: Aspirin; Drug: Placebo

• Registration Number: NCT02047539
• Lead Sponsor: Yale University

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.

Study Timeline

• Study First Submitted: 2014-01-24
• Study First Submitted QC: 2014-01-27
• Study First Posted: 2014-01-28
• Study Start: 2015-01
• Primary Completion: 2021-03
• Study Completion: 2021-03
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-13
• Last Update Posted: 2021-05-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1000 mg/day aspirin	Aspirin	1000 mg/day aspirin
sugar pill	Placebo	sugar pill

Primary Outcome Measures

Name	Time	Method
Scale of Prodromal Symptoms (SOPS)	12 weeks	Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo

Trial Locations

Locations (1)

PRIME Research Clinic; 🇺🇸 New Haven, Connecticut, United States