Schizophrenia Clinical Trial
Official title:
Detecting Which Patients With Schizophrenia Will Improve With Omega-3 Treatment
This 16-week placebo-control study looks to investigate whether patients with schizophrenia for two years or less may benefit from omega-3 supplements.
This study looks to investigate whether patients with schizophrenia for 2 years or less may
benefit from omega-3 supplements. The main hypothesis to be tested in this study is that
white matter integrity assessed with diffusion tensor imaging (DTI) and erythrocyte membrane
omega-3 concentration may provide the means for identifying patients most likely to derive
clinical benefit from omega-3 supplementation.
To test this hypothesis the investigators will enroll 58 patients with recent-onset
schizophrenia into a 16-week long randomized double blind placebo-controlled study of
risperidone versus risperidone plus omega-3 supplementation. Study assessments after consent
will include a baseline MRI and an MRI at the final visit, blood-work, clinical interviews
to assess symptoms, and medical assessments for side effects. DTI exams and peripheral
omega-3 concentration will be obtained prior to the initiation of treatment and the primary
outcome measure will be the total Brief Psychiatric Rating Scale Score.
Specific aims are:
- To examine the efficacy of omega-3 fatty acids as an adjuvant agent in the treatment of
patients with recent-onset schizophrenia. The investigators hypothesize that patients
treated with omega-3 fatty acids will demonstrate greater Brief Psychiatric Rating
Scale (BPRS) reductions compared to the placebo group.
- To identify whether pre-treatment fractional anisotropy (FA) assessed by DTI predicts
which patients will derive clinical benefit from omega-3 fatty acids. The investigators
hypothesize that patients with lower fractional anisotropy will derive greater clinical
benefit from omega-3 fatty acid supplementation.
- To identify whether pre-treatment peripheral omega-3 fatty acid concentrations predict
which patients will derive clinical benefit from omega-3 fatty acids. The investigators
hypothesize that patients with lower peripheral omega-3 fatty acid concentrations will
derive greater clinical benefit from omega-3 fatty acid supplementation.
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