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

May 13, 2021 updated by: Yale University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • PRIME Research Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1000 mg/day aspirin
Drug: Aspirin
1000 mg/day of aspirin 1000 mg/day of sugar pill
Placebo Comparator: sugar pill
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Scale of Prodromal Symptoms (SOPS)
Time Frame: 2 weeks
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
2 weeks
Scale of Prodromal Symptoms (SOPS)
Time Frame: 4 weeks
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
4 weeks
Scale of Prodromal Symptoms (SOPS)
Time Frame: 8 weeks
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
8 weeks
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
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Scott W Woods, MD, Yale University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

January 24, 2014

First Submitted That Met QC Criteria

January 27, 2014

First Posted (Estimate)

January 28, 2014

Study Record Updates

Last Update Posted (Actual)

May 17, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1401013288

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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