This was a triple blind, prospective clinical trial study. The population included patients with schizophrenia based on clinical interview and DSM-IV-TR within the age group of 18-65 years old referred to Noor Hospital psychiatric clinic or emergency. The purpose of this project, methods and frequency of follow-up were entirely explained to the patients or their legal guardians. The subjects participated upon their written consent. The inclusion criteria were age of 18-65 years old, diagnosed with schizophrenia based on clinical interview and DSM-IV-TR, patients with 2 years of history since the onset of the disease. The exclusion criteria were unwillingness to participate in the study, failure to see doctor for follow-up for whatever reason, unstable medical illness and medical history, contra indications for use of aspirin, such as asthma or seasonal allergies, ulcers, kidney disease, active bleeding or clotting of blood disorders such as hemophilia or bleeding, gout, nasal polyps, chronic use of NSAID, concomitant use of corticosteroids for any reason and maternity.
The patients were randomly through a number table divided into three groups of 20 members labeled intervention 1, intervention 2 and control. Patients in each group were initially evaluated through PANSS scale in terms of severity of schizophrenia symptoms. At baseline, clinical evaluation involved cell count, liver function, kidney, thyroid and cardiac function tests. Moreover, the cardiac status was assessed through routine ECG. The patients were then referred to a psychiatrist who prescribed medication.
In addition to antipsychotic medication, intervention 1 received daily aspirin produced by Daroupakhsh Co for 6 weeks at a dose of 500 mg, while intervention 2, in addition to antipsychotic medication, received daily aspirin with a dose of 325 mg for 6 weeks. The control, in addition to antipsychotic medication, received daily placebo for 6 weeks for 6 weeks. It should be noted the placebo had been produced in the same shape and color of the effective aspirin. Drug and placebo were coded A, B, and C. In order to reduce the gastrointestinal side effects, Omeprazole 20 mg daily was given to each patient. Neither the examiner nor the clinician and the patient were aware of the drug compounds since they were labeled A, B, and C.
The PANSS scale was administered on the first day, the end of the sixth week and one month after cessation of aspirin or placebo, followed by recording and comparing the scores. The data were analyzed through SPSS 20, and based on descriptive statistics of frequency distribution, mean and standard deviation. Moreover, the results of the test were compared through Repeated Measure and logistic regression.