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

Primary Purpose

Clinical High Risk for Psychosis

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Aspirin
Placebo
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Clinical High Risk for Psychosis

Eligibility Criteria

19 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PRIME Research Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1000 mg/day aspirin

sugar pill

Arm Description

1000 mg/day aspirin

sugar pill

Outcomes

Primary Outcome Measures

Scale of Prodromal Symptoms (SOPS)
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Scale of Prodromal Symptoms (SOPS)
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Scale of Prodromal Symptoms (SOPS)
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Scale of Prodromal Symptoms (SOPS)
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo

Secondary Outcome Measures

Full Information

First Posted
January 24, 2014
Last Updated
May 13, 2021
Sponsor
Yale University
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1. Study Identification

Unique Protocol Identification Number
NCT02047539
Brief Title
Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis
Official Title
Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Terminated
Study Start Date
January 2015 (undefined)
Primary Completion Date
March 2021 (Actual)
Study Completion Date
March 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University

4. Oversight

Data Monitoring Committee
No

5. 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.
Detailed Description
Patients will be randomly assigned to either active treatment (aspirin) or placebo.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical High Risk for Psychosis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1000 mg/day aspirin
Arm Type
Experimental
Arm Description
1000 mg/day aspirin
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
sugar pill
Intervention Type
Drug
Intervention Name(s)
Aspirin
Intervention Description
1000 mg/day of aspirin 1000 mg/day of sugar pill
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Scale of Prodromal Symptoms (SOPS)
Description
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Time Frame
2 weeks
Title
Scale of Prodromal Symptoms (SOPS)
Description
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Time Frame
4 weeks
Title
Scale of Prodromal Symptoms (SOPS)
Description
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Time Frame
8 weeks
Title
Scale of Prodromal Symptoms (SOPS)
Description
Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott W Woods, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
PRIME Research Clinic
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States

12. IPD Sharing Statement

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

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