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

NCT02047539 | Terminated Early Phase 1

• 1 other identifier: 1401013288
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Clinical High Risk for Psychosis

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

1000 mg/day aspirin

EXPERIMENTAL

1000 mg/day aspirin

Drug: Aspirin

sugar pill

PLACEBO COMPARATOR

sugar pill

Drug: Placebo

Interventions

Aspirin DRUG

1000 mg/day of aspirin 1000 mg/day of sugar pill

1000 mg/day aspirin

Placebo DRUG

sugar pill

Eligibility Criteria

• Age: 19 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

PRIME Research Clinic

New Haven, Connecticut, 06519, United States

Location

MeSH Terms

Interventions

Aspirin

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Scott W Woods, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: January 1, 2015
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: May 17, 2021

Record last verified: 2021-05

Locations

US (1)