schizophrenia and schizoaffective disorder. MedDRA version: 17.0 Level: PT Classification code 10039626 Term: Schizophrenia System Organ Class: 10037175 - Psychiatric disorders MedDRA version: 17.0 Level: PT Classification code 10039621 Term: Schizoaffective disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Acetylsalicylic acid 500mg
Pharmaceutical Form: Capsule, soft
INN or Proposed INN: Acetylsalicylic acid
Other descriptive name: ASPIRIN
Concentration unit: mg milligram(s)
Concentration t
Sponsors
Clinirx Tangent Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female, 18-65 years of age, inclusive 2. Females who are abstinent or practicing an established method of birth control (oral contraceptive tablets, hormonal implant device, hormone patch, injectable contraceptive, intrauterine device [IUD]). 3. Willing and able to provide informed consent, after the nature of the study has been fully explained 4. Current DSM-IV-TR diagnosis of schizophrenia or schizoaffective disorder as confirmed by modified SCID and having had at least 2 prior schizophrenic episodes, or continually ill for at least 6 months. 5. CRP = 1mg/L 6. Symptoms: 4 (moderate) or above on CGI-S and ? 4 (moderate) score on two of the following four PANSS positive items: delusions, hallucinatory behaviors, conceptual disorganization or suspiciousness/ persecution. 7. Must be on any antipsychotic drug for at least 2 weeks prior to the baseline visit, at doses within the PORT criteria, whenever possible. Patients receiving higher doses will have their records reviewed to insure that their dose is required and, if possible, will be stabilized on a lower dose prior to study entry. 8. Inpatients or outpatients. Inpatients will be randomized 3 days or more after admission Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 160 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Unwilling or unable, in the opinion of the Investigator, to comply with study instructions 2. Pregnant or breast-feeding 3. Unstable medical disease (malignancy, poorly controlled diabetes, active ischemic cardiac disease, or cardiomyopathy, serious pulmonary disease, kidney disease, impaired liver functioning, history of hemorrhagic CVA or peptic ulcer disease). 4. Patients treated with acetylsalicylic acid, NSAIDs, anti-coagulants. 5. Likely allergy or sensitivity to acetylsalicylic acid. 6. At significant risk of committing suicide, or in the opinion of the Investigator, currently is at imminent risk of suicide or harming others. 7. Patients with a current DSM-IV substance or alcohol abuse. Patients with a history of and/or current recreational use of cannabinoids or alcohol, and/or patients who smoke cigarettes can be included. 8. Concurrent delirium, mental retardation, drug-induced psychosis, or history of clinically significant brain trauma documented by CT or MRI.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objective of the study is to evaluate the efficacy of Aspirin compared to placebo, as add-on to anti-psychotics in the treatment of patients with schizophrenia or schizo-affective disorders with high (CRP>1 g/L) sera level;Secondary Objective: 1. PANSS positive, negative and psychopatology scales 2. Clinical Global Impression Scale Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I) 3. Brief Assessment of Cognition in Schizophrenia (BACS) 4. Rate of drop outs before the end of the trial ;Primary end point(s): PANSS total score at the end of the trial.;Timepoint(s) of evaluation of this end point: At the end of the trial. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. PANSS positive, negative and general psychopathology scales, 2. Clinical Global Impression Scale-Severity (CGI-S) and Global Impression Scale-Improvement (CGI-I), 3. Brief Assessment of Cognition in Schizophrenia (BACS) and 4. Rates of drop outs before the end of the trial.;Timepoint(s) of evaluation of this end point: The end of the trial. | — |
Countries
Romania
Contacts
Public ContactPaull G. Radu
Clinirx Tangent Research
Outcome results
None listed