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

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

Status

Terminated

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02047539

Enrollment

Registered

2014-01-28

Start date

2015-01-31

Completion date

2021-03-31

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clinical High Risk for Psychosis

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.

Interventions

DRUGAspirin

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

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

19 Years to 35 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Scale of Prodromal Symptoms (SOPS)	2 weeks	Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026