Submission date
01/07/2001
Registration date
01/07/2001
Last edited
07/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results added
? Raw data not yet added
Study completed

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

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/CTIS number

IRAS 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(s)

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Hospital

Study 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

Pharmaceutical study type(s)

Phase

Not Specified

Drug/device/biological/vaccine name(s)

Ethyl-eicosapentaenoate (ethyl-EPA)

Primary outcome measure

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall study start date

01/06/2000

Overall study end date

01/06/2001

Reason abandoned (if study stopped)

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(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

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

Scotland, United Kingdom

Study 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/

ROR

https://ror.org/03gc62f43

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

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/01/2002 Yes No

Additional files

Editorial Notes