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

Information source: Oslo University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia; Schizophreniform Disorders; Schizoaffective Disorder; Psychotic Disorders

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

Phase: Phase 2/Phase 3

Status: Completed

Sponsored by: University Hospital, Aker

Official(s) and/or principal investigator(s):
Håvard Bentsen, MD PhD, Study Director, Affiliation: Aker University Hospital (-2004), Diakonhjemmet Hospital (2004-)
Odd Lingjærde, MD PhD, Study Chair, Affiliation: University Hospital, Aker

Summary

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.

Clinical Details

Official title: A Multicentre, Placebo-controlled Trial of Eicosapentaenoic Acid (EPA) and Antioxidant Supplementation in the Treatment of Schizophrenia and Related Disorders

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Positive and Negative Syndrome Scale (PANSS)- Total

Secondary outcome:

PANSS Subscales Negative, Positive, General Psychopathology

GLOBAL ASSESSMENT OF FUNCTIONING- Split Version (S-GAF)

WONCA-COOP FUNCTIONAL HEALTH ASSESSMENT CHARTS

NIACIN SKIN FLUSH TEST

THE UKU SIDE EFFECT RATING SCALE (USERS)

SERIOUS ADVERSE EVENTS

CONCOMITANT ANTIPSYCHOTIC MEDICATION

Kimura Recurring Recognition Figures Test

Hopkins Verbal Learning Test.

Continuous Performance Test

Hopkins Verbal Learning Test

Paced Auditory Serial Addition Test

Stroop Test

Digit Span

The Letter - Number Task

Semantic and Category Fluency

Body Mass Index

Blood pressure - systolic, diastolic

Heart rate

Albumin

Urate

Glucose

Cholesterol

Triglycerides

Fatty acids in red blood cells

Alpha-tocopherol adjusted for [triglycerides]+[cholesterol].

Total antioxidant status

Malondialdehyde

F2-isoprostane (8-epiPGF2-alpha)

Cytosolic PLA2 group IV in red blood cells(ELISA method)

Gene expression of mRNA for Phospholipase A2 (PLA2) groups IVa and VIa in monocytes.

Mean Corpuscular Haemoglobin Concentration (MCHC)

Mean Corpuscular Volume (MCV)

C- Reactive Protein (CRP)

Haemoglobin

Leukocytes

Calcium

Sodium

Potassium

Ferritin

Free thyroxin (T4)

Thyroid Stimulating Hormone (TSH)

Detailed 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).

Eligibility

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Both.

Criteria:

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)

Locations and Contacts

Aker University Hospital, Oslo 0320, Norway
Additional Information

Starting date: September 2001
Last updated: January 3, 2011

Page last updated: August 23, 2015

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