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

Early Phase 1TerminatedNCT02047539

Yale University1 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE

Enrollment

Conditions

Clinical High Risk for Psychosis

Interventions

AspirinDRUG

1000 mg/day of aspirin 1000 mg/day of sugar pill

PlaceboDRUG

Eligibility

Sex: ALLMin age: 19 YearsMax age: 35 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PRIME Research Clinic

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Scale of Prodromal Symptoms (SOPS)

Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 12 weeks

Data from ClinicalTrials.gov

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