Treatment of Schizophrenia With an Omega-3 Fatty Acid (EPA) and Antioxidants

University Hospital, Aker

Status and phase: Completed; Phase 3; Phase 2

Conditions: Schizophreniform Disorders; Psychotic Disorders; Schizophrenia; Schizoaffective Disorder

Treatments: Drug: Ethyl-eicosapentaenoic acid (EPA); Other: Vitamins E+C (placebo); Drug: Vitamins E + C; Other: Etyl EPA (placebo)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00419146

LA.01.07.0001

01T-106 (Stanley M.R.I.,USA)

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 99 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients with schizophrenia, schizophreniform disorder or schizoaffective disorder (DSM-IV)
• Admitted to a psychiatric hospital/department within the previous twenty-one days before screening
• Less than fifteen years, in retrospect, since first psychotic symptoms (DSM-IV 295, criteria A,1-4)
• Age 18-40 years
• Speaks fluently a Scandinavian language
• A written informed consent must be obtained before any trial-related activities

Exclusion criteria

• A diagnosis of substance dependence (DSM-IV)
• Known allergy to study medication
• Currently taking warfarin or having anamnestic indicators of impaired haemostasis (profuse bleeding, except epistaxis)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Quadruple Blind

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99 participants in 4 patient groups, including a placebo group

Ethyl EPA (active) and Vitamins E + C (active)

Experimental group

Treatment:

Drug: Vitamins E + C

Drug: Ethyl-eicosapentaenoic acid (EPA)

Ethyl EPA (active) and Vitamins E+C (placebo)

Experimental group

Treatment:

Other: Vitamins E+C (placebo)

Drug: Ethyl-eicosapentaenoic acid (EPA)

Ethyl EPA (placebo) and Vitamins E+C (active)

Experimental group

Treatment:

Other: Etyl EPA (placebo)

Drug: Vitamins E + C

Ethyl EPA (placebo) and Vitamins E+C (placebo)

Placebo Comparator group

Treatment:

Other: Vitamins E+C (placebo)