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ISRCTN
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ISRCTN44366049
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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 (EPA) as adjunct therapy in patients who remain depressed following treatment with standard antidepressant therapy
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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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LA01.01.0002
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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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Multicentre, double-blind, randomised, parallel group, placebo-controlled, dose ranging pilot study
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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. Hamilton score of 14 or more
3. Treatment for =8 weeks with one or more standard antidepressants, with no change in antidepressant dosage or drug for at least 4 weeks; likely to be maintained on this treatment and dosage for the duration of the study
4. Diagnosis of major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition [DSM IV])
5. Male or female, of any race, aged 18-65
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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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01/01/2002
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Anticipated end date
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31/12/2002
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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 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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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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26/02/2002
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Last edited
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28/04/2008
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Date ISRCTN assigned
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26/02/2002
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