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

Conditions:Psychiatric, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Age Range:19 - 35
Start Date:January 2015
End Date:March 2018
Contact:Scott W Woods, MD

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Randomized Controlled Trial of Aspirin vs Placebo in the Treatment of Patients With the Clinical Risk Syndrome for Psychosis

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.

Patients will be randomly assigned to either active treatment (aspirin) or placebo.

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
We found this trial at
New Haven, Connecticut 06519
Principal Investigator: Scott W Woods, MD
New Haven, CT
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