Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis (NCT02047539) | Clinical Trial Compass
TerminatedEarly Phase 1
Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Pre-psychosis
United States1 participantsStarted 2015-01
Plain-language 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.
Who can participate
Age range
19 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.