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ISRCTN
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ISRCTN63565713
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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 trial of LAX-101 (ethyl eicosapentaenoate [EPA]) in patients with a new or recurrent episode of depression
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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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LA01.01.0008A
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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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Depression
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Participants - inclusion criteria
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1. Written informed consent
2. Diagnosis of major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth edition [DSM-IV])
3. Score of between and including 16 and 25 on the Hamilton Depression Rating Scale (HDRS)
4. No treatment with any antidepressant medication (including St John's Wort) in the last 12 weeks from the date of Visit 0 (screen)
5. Male or female of any race aged 18-75
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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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01/01/2003
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Anticipated end date
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01/01/2004
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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 randomly allocated to placebo, 0.5 g, 1 g or 2 g/day ethyl EPA on a double blind basis.
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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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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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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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admin@Laxdale.co.uk
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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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03/02/2003
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Last edited
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19/05/2008
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Date ISRCTN assigned
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03/02/2003
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