Essential Fatty Acid Supplementation in Psychosis

A study investigating the influence of eicosapentanoic acid (EPA) supplementation in First Episode Psychotic Patients on clinical outcome and cognition

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12605000267651

Enrollment

Registered

2005-09-02

Start date

1999-11-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study investigates the influence of Eicosapentanoic acid (EPA) in first episode psychotic patients. The influence of EPA supplementation has been investigated only in neuroleptic-treated, mostly chronic patients with schizophrenia. The effect size of EPA supplementation in addition to antipsychotic treatment in these studies was approximately 20%. We suggest that the effect in early course of illness is even stronger and long-term consequences could be avoided. For ethical reasons at this point ALL patients get a standard treatment with an atypical antipsychotic (standard treatment for first episode patients at EPPIC) in a flexible dose regime. After inclusion into the study patients are randomised to two arms. One arm will be supplemented with a mineral oil (4 capsules of 0.5g) which is not absorbed by the gastrointestinal tract (placebo group). The other arm will be supplemented with purified Eicosapentanoic acid (4 capsules of 0.5g). Patients who give written informed consent will do standard clinical and neuropsychological tests (CANTAB) at baseline and after 12 weeks of supplementation (pre/post study design). A topical Niacin flush test (already approved by the research and ethics committee within following project: Psychobiology and Prevention of Transition to Psychosis 29/7/99) will also be applied at baseline and after 12weeks.

Interventions

2 g eicosapenaenoic acid added on to standard treatment

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

15 Years to 29 Years

Healthy volunteers

Inclusion criteria

Patients meeting criteria for first episode psychosis, living in the North Western region of Melbourne, encompassing patients with DSM IV diagnosis of schizoprenia, schizoprheniform psychosis, schizoaffective disorder, Psychosis NOS.

Exclusion criteria

No exclusion criteria

Outcome results