Status:
COMPLETED
Anti-Inflammatory Treatment of Schizophrenia
Lead Sponsor:
University of Maryland, Baltimore
Conditions:
Schizophrenia
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Despite current antipsychotic treatment, the majority of people with schizophrenia continue to exhibit persistent positive and negative symptoms and cognitive impairments. An alternative approach to t...
Detailed Description
Schizophrenia has been hypothesized to be due, in part, to disruptions of normal immune system and inflammatory responses to viral or bacterial infections or other stimuli of these systems. Epidemiolo...
Eligibility Criteria
Inclusion
- Participants will meet DSM-IV-TR criteria for schizophrenia or schizoaffective disorder.
- Participants will be required to meet the following symptom criteria:
- BPRS total score of 45 or greater on the 18 item version (scale: 1-7) or a Clinical Global Impression (CGI) severity of illness item score of 4 (moderate) or greater.
- BPRS positive symptom item total score of 8 or greater and a score of 4 or more on at least one individual item.
- Participants will be clinically stable, be treated with the same antipsychotic for at least 60 days and a constant therapeutic dose for at least 30 days prior to study entry.
- Participants must be judged competent to participate in the informed consent process and provide voluntary informed consent
Exclusion
- Participants who meet DSM-IV-TR criteria for alcohol or substance dependence (except nicotine) within the last 6 months or DSM-IV-TR criteria for alcohol or substance abuse (except nicotine) within the last month will be excluded
- Participants with a current infection or an organic brain disorder or medical condition, whose pathology or treatment could alter the presentation or treatment of schizophrenia or significantly increase the risk associated with the proposed treatment protocol will be excluded.
- Participants with a history of: aspirin allergy, pre-existing tinnitus, tuberculosis, HIV, or hepatitis C; or autoimmune disease.
- Participants who are currently treated with a statin, warfarin, dipyridamole, or other anti-coagulants.
- Participant is currently treated with an omega-3-fatty acid preparation and cannot discontinue their use of the preparation for the duration of the study.
- Female participant who is sexually active and not using any form of birth control such as oral contraceptives or IUDs.
- Female participant who is pregnant or breastfeeding.
- Participant with current/active peptic ulcer disease or gastritis; anemia or thrombocytopenia (platelet count ≤120).
- Participant who is currently treated with a medication that can increase the risk of myopathy and rhabdomyolysis such as Fluconazole, Ketoconazole, Colchicine, Daptomycin, Erythromycin, or immunosuppressants that alter statin levels.
Key Trial Info
Start Date :
June 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2017
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01514682
Start Date
June 1 2012
End Date
April 17 2017
Last Update
March 3 2022
Active Locations (1)
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1
Maryland Psychiatric Research Center
Baltimore, Maryland, United States, 21228