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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 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 :	January 2015
Estimated Primary Completion Date :	March 2018
Estimated Study Completion Date :	March 2018

Arms and Interventions

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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

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Primary Outcome Measures :

1. Scale of Prodromal Symptoms (SOPS) [ Time Frame: 2 weeks ]
   Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
2. Scale of Prodromal Symptoms (SOPS) [ Time Frame: 4 weeks ]
   Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
3. Scale of Prodromal Symptoms (SOPS) [ Time Frame: 8 weeks ]
   Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo
4. Scale of Prodromal Symptoms (SOPS) [ Time Frame: 12 weeks ]
   Patients randomized to aspirin will improve significantly more on the SOPS total score than patients randomized to placebo

Eligibility Criteria

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Ages Eligible for Study:	19 Years to 35 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Scott W Woods, MD	2039747038	scott.woods@yale.edu

Locations

United States, Connecticut
PRIME Research Clinic	Recruiting
New Haven, Connecticut, United States, 06519
Principal Investigator: Scott W Woods, MD

Sponsors and Collaborators

Yale University

Investigators

Principal Investigator:	Scott W Woods, MD	Yale University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Yale University
ClinicalTrials.gov Identifier:	NCT02047539 History of Changes
Other Study ID Numbers:	1401013288
First Posted:	January 28, 2014
Last Update Posted:	January 16, 2018
Last Verified:	January 2018

Additional relevant MeSH terms:

Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Aspirin; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs	Anti-Inflammatory Agents; Antirheumatic Agents; Fibrinolytic Agents; Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Antipyretics