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
About this trial
This is an interventional health services research trial for Clinical High Risk for Psychosis
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
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
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
Learn more about this trial
Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis
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