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

NCT ID: NCT02047539

Last Updated: 2021-05-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

EARLY_PHASE1

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-31

Study Completion Date

2021-03-31

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.

Conditions

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Clinical High Risk for Psychosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1000 mg/day aspirin

1000 mg/day aspirin

Group Type EXPERIMENTAL

Aspirin

Intervention Type DRUG

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

sugar pill

sugar pill

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Aspirin

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

Intervention Type DRUG

Placebo

Intervention Type DRUG

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
Minimum Eligible Age

19 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott W Woods, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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PRIME Research Clinic

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1401013288

Identifier Type: -

Identifier Source: org_study_id

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