Trial registered on ANZCTR


Trial ID
ACTRN12605000267651
Ethics application status
Approved
Date submitted
30/08/2005
Date registered
2/09/2005
Date last updated
2/09/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Essential Fatty Acid Supplementation in Psychosis
Scientific title
A study investigating the influence of eicosapentanoic acid (EPA) supplementation in First Episode Psychotic Patients on clinical outcome and cognition
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
First episode Psychosis 354 0
Condition category
Condition code
Mental Health 415 415 0 0
Psychosis and personality disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 g eicosapenaenoic acid added on to standard treatment
Intervention code [1] 313 0
Treatment: drugs
Comparator / control treatment
Standed treatment
Control group
Placebo

Outcomes
Primary outcome [1] 474 0
Symptomatic improvement measured in change scores
Timepoint [1] 474 0
Primary outcome [2] 475 0
Symptomatic improvement measured in time to remission
Timepoint [2] 475 0
Primary outcome [3] 476 0
Symptomatic improvement measured in time to response
Timepoint [3] 476 0
Primary outcome [4] 477 0
Symptomatic improvement measured in total commulative dose
Timepoint [4] 477 0
Secondary outcome [1] 1032 0
Tolerability measures: Extra-pyramidal symptoms , niacin sensitivity as predictor for treatment response to EPA, effects of EPA on H-Magnetic Resonance spectroscpy, effects of EPA on cognition.
Timepoint [1] 1032 0

Eligibility
Key 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.
Minimum age
15 Years
Maximum age
29 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
numbered containers (provided by clinical trials pharmacy of the Royal Melbourne Hospital)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
computer generated randomization (no stratification)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
add on to standard antipsychotic treatment
Phase
Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 466 0
Charities/Societies/Foundations
Name [1] 466 0
Swiss Natioanl Science Foudation
Address [1] 466 0
Country [1] 466 0
Switzerland
Funding source category [2] 467 0
Charities/Societies/Foundations
Name [2] 467 0
M&W lichtenstein Foundation
Address [2] 467 0
Country [2] 467 0
Funding source category [3] 468 0
University
Name [3] 468 0
Laxdale Ltd.
Address [3] 468 0
Country [3] 468 0
United Kingdom
Funding source category [4] 469 0
Other
Name [4] 469 0
ORYGEN Research Centre
Address [4] 469 0
Country [4] 469 0
Australia
Primary sponsor type
Government body
Name
Swiss National Science Foundation
Address
Country
Switzerland
Secondary sponsor category [1] 376 0
Commercial sector/Industry
Name [1] 376 0
Laxdale Ltd
Address [1] 376 0
Country [1] 376 0
United Kingdom

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1442 0
North Western Mental Health Research & Ethics committee
Ethics committee address [1] 1442 0
Ethics committee country [1] 1442 0
Australia
Date submitted for ethics approval [1] 1442 0
Approval date [1] 1442 0
Ethics approval number [1] 1442 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35921 0
Address 35921 0
Country 35921 0
Phone 35921 0
Fax 35921 0
Email 35921 0
Contact person for public queries
Name 9502 0
Gregor Berger
Address 9502 0
ORYGEN Research Centre
35 Poplar Rd
Parkville VIC 3052
Country 9502 0
Australia
Phone 9502 0
+61 3 93422800
Fax 9502 0
+61 3 93873003
Email 9502 0
gregor@unimelb.edu.au
Contact person for scientific queries
Name 430 0
Gregor Berger
Address 430 0
ORYGEN Research Centre
35 Poplar Rd
Parkville VIC 3052
Country 430 0
Australia
Phone 430 0
+61 3 93422800
Fax 430 0
+61 3 93873003
Email 430 0
gregor@unimelb.edu.au