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.
1This trial was terminated before completing — do you know why it was stopped early, and does that affect what we can learn from its results about using aspirin for pre-psychosis symptoms?
2Since this was an early Phase 1 trial testing aspirin against a placebo for clinical high risk of psychosis, what does that tell us about how much is actually known regarding its safety and effectiveness at this stage?
3The trial used something called the Scale of Prodromal Symptoms to measure outcomes — can you explain what that scale measures and whether my current symptoms would even have been relevant to what this study was tracking?
4Given that this trial was terminated and is no longer enrolling, are there other active studies or standard care approaches you'd recommend for someone at clinical high risk for psychosis instead?
5Is aspirin something that's being seriously explored in treating pre-psychosis more broadly, or was this a very early exploratory study, and how should I factor that into thinking about my own treatment options?
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.