Schizophrenia Clinical Trial
Official title:
A Multicentre, Placebo-controlled Trial of Eicosapentaenoic Acid (EPA) and Antioxidant Supplementation in the Treatment of Schizophrenia and Related Disorders
The purpose of this trial is to study the effect of adding the omega-3 fatty acid EPA and/or Vitamins E + C to antipsychotic drugs in younger patients with schizophrenia and related psychoses.
Objective:
Study the effect of adding Ethyl-EPA and/or Vitamins E + C to antipsychotic drugs in younger
patients with schizophrenia and related psychoses.
Methods and material:
- Design: Multicentre, randomized, double-blind, placebo-controlled, fixed dose, 2x2
factorial, add-on clinical trial.
- Sample:
- Patients with schizophrenia, schizoaffective disorder or schizophreniform disorder
(DSM-IV); aged 18-40 years; less than 15 years since first psychotic
symptoms;admitted to a psychiatric department within the previous 21 days before
screening; speaks fluently a Scandinavian language;treated with antipsychotics;
written informed consent;no known allergy to trial agents;no substance dependence
(DSM-IV);no warfarin currently or anamnestic indicators of impaired haemostasis.
Planned: 200 patients. Actually included: 99 intent-to-treat patients.
- Healthy controls: aged 18-40 years;no mental disorder (DSM-IV). Included: 20
persons.
- Clinical assessments: Positive and Negative Syndrome Scale (PANSS) (main outcome
variable). Self-report questionnaire. Adverse effects (UKURS). Neurocognitive
assessment battery. Niacin skin flush test. General medical assessment.
- Blood samples: RBC fatty acids, S-α-tocopherol, F2-isoprostane (kits), monocyte mRNA
Phospholipase A22 (PLA2) Gr4a and 6a (RT-PCR method), RBC Gr4a PLA2 concentration
(ELISA technique), a range of other biochemical tests.
- Experimental treatment over 16 weeks: Ethyl-EPA 2 g/d or Placebo EPA and Vitamin E 364
mg/d + Vitamin C 1000 mg/d or Placebo Antioxidants
- Statistics: Linear Mixed Model for longitudinal analyses of effects; other uni- and
multivariate methods (SPSS 12.0 - PASW Statistics 18).
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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