Condition category
Mental and Behavioural Disorders
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
07/09/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Harald Murck

ORCID ID

Contact details

Laxdale Ltd
Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
FK7 9JQ
United Kingdom
+44 (0)1786 476001
hmurck@laxdale.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

LA.01.01.0001

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Schizophrenia

Intervention

Four groups were randomly allocated to placebo or 1 g, 2 g or 4 g ethyl-EPA/day on a double blind basis. Treatment duration 12 weeks.

Intervention type

Drug

Phase

Not Specified

Drug names

Ethyl-eicosapentaenoate (ethyl-EPA)

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/06/2000

Overall trial end date

01/06/2001

Reason abandoned

Eligibility

Participant inclusion criteria

1. Written informed consent
2. Diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
3. Minimum duration of 12 weeks from diagnosis
4. Maximum duration of 20 years from diagnosis
5. Maintained on same neuroleptic drug(s) for 12 weeks and on the same dose for 4 weeks
6. Total Positive and Negative Syndrome Scale (PANSS) score of 50 or more and a positive sub-scale PANSS score of 15 or more
7. Aged 18 - 65 of either sex
8. In-patient or out-patient

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/06/2000

Recruitment end date

01/06/2001

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Laxdale Ltd
Stirling
FK7 9JQ
United Kingdom

Sponsor information

Organisation

Laxdale Ltd (UK)

Sponsor details

Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
FK7 9JQ
United Kingdom

Sponsor type

Industry

Website

http://www.laxdale.co.uk/

Funders

Funder type

Industry

Funder name

Laxdale Ltd (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11755456

Publication citations

  1. Results

    Peet M, Horrobin DF, , A dose-ranging exploratory study of the effects of ethyl-eicosapentaenoate in patients with persistent schizophrenic symptoms., J Psychiatr Res, 36, 1, 7-18.

Additional files

Editorial Notes