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ISRCTN
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ISRCTN44218911
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ClinicalTrials.gov identifier
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Public title
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A multicentre, double-blind, randomised, parallel group, placebo-controlled, dose-ranging pilot study of ethyl-eicosapentaenoate (ethyl-EPA) in patients with schizophrenia
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Scientific title
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Acronym
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N/A
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Serial number at source
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LA.01.01.0001
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Study hypothesis
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Schizophrenia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/06/2000
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Anticipated end date
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01/06/2001
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Laxdale Ltd (UK)
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Trial website
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Publications
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Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11755456
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Contact name
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Dr
Harald
Murck
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Address
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Laxdale Ltd
Kings Park House
Laurelhill Business Park
Polmaise Road
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City/town
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Stirling
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Zip/Postcode
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FK7 9JQ
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Country
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United Kingdom
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Tel
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+44 (0)1786 476001
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Fax
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+44 (0)1786 473137
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Email
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hmurck@laxdale.co.uk
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Sponsor
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Laxdale Ltd (UK)
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Address
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Kings Park House
Laurelhill Business Park
Polmaise Road
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City/town
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Stirling
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Zip/Postcode
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FK7 9JQ
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Country
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United Kingdom
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Sponsor website:
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http://www.laxdale.co.uk/
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Date applied
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01/07/2001
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Last edited
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07/09/2007
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Date ISRCTN assigned
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01/07/2001
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