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

Sponsor
Yale University (Other)
Overall Status
Terminated
CT.gov ID
NCT02047539
Collaborator
(none)
1
Enrollment
1
Location
2
Arms
74
Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
Early Phase 1

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis
Study Start Date :
Jan 1, 2015
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Mar 1, 2021

Arms and Interventions

ArmIntervention/Treatment
Experimental: 1000 mg/day aspirin

1000 mg/day aspirin

Drug: Aspirin
1000 mg/day of aspirin 1000 mg/day of sugar pill

Placebo Comparator: sugar pill

sugar pill

Drug: Placebo

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Scale of Prodromal Symptoms (SOPS) [4 weeks]

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

  3. Scale of Prodromal Symptoms (SOPS) [8 weeks]

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

  4. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 35 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1PRIME Research ClinicNew HavenConnecticutUnited States06519

Sponsors and Collaborators

  • Yale University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yale University
ClinicalTrials.gov Identifier:
NCT02047539
Other Study ID Numbers:
  • 1401013288
First Posted:
Jan 28, 2014
Last Update Posted:
May 17, 2021
Last Verified:
May 1, 2021
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 17, 2021