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)

Enrollment

Location

Arms

Duration (Months)

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 Disease	Intervention/Treatment	Phase
Clinical High Risk for Psychosis	Drug: Aspirin Drug: Placebo	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

Arm	Intervention/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

Arm

Intervention/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

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
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
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
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

	Site	City	State	Country	Postal Code
1	PRIME Research Clinic	New Haven	Connecticut	United States	06519

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:

Psychotic Disorders

Mental Disorders

Aspirin

Study Results

No Results Posted as of May 17, 2021