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
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
Publication citations
-
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.