Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis
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ClinicalTrials.gov Identifier: NCT02047539 |
Recruitment Status
:
Recruiting
First Posted
: January 28, 2014
Last Update Posted
: January 16, 2018
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Clinical High Risk for Psychosis | Drug: Aspirin Drug: Placebo | Early Phase 1 |
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 |

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 |
- 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
- 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
- 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
- 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

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Ages Eligible for Study: | 19 Years to 35 Years (Adult) |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047539
Contact: Scott W Woods, MD | 2039747038 | scott.woods@yale.edu |
United States, Connecticut | |
PRIME Research Clinic | Recruiting |
New Haven, Connecticut, United States, 06519 | |
Principal Investigator: Scott W Woods, MD |
Principal Investigator: | Scott W Woods, MD | Yale University |
Responsible Party: | Yale University |
ClinicalTrials.gov Identifier: | NCT02047539 History of Changes |
Other Study ID Numbers: |
1401013288 |
First Posted: | January 28, 2014 Key Record Dates |
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 |