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

Clinical High Risk for Psychosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02047539
• Other study ID #: 1401013288
• Status: Terminated
• Phase: Early Phase 1
• Start date: January 2015
• Est. completion date: March 2021

Study information

• Verified date: May 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical High Risk for Psychosis
• Mental Disorders
• Psychotic Disorders

Intervention

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

Locations

Country	Name	City	State
United States	PRIME Research Clinic	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Scale of Prodromal Symptoms (SOPS)	Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo	2 weeks
Primary	Scale of Prodromal Symptoms (SOPS)	Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo	4 weeks
Primary	Scale of Prodromal Symptoms (SOPS)	Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo	8 weeks
Primary	Scale of Prodromal Symptoms (SOPS)	Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo	12 weeks