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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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7 November 2016 |
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Main ID: |
ISRCTN63565713 |
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Date of registration:
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03/02/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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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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Date of first enrolment:
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01/01/2003 |
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Target sample size:
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0 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN63565713 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Not Specified
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Harald
Murck |
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Address:
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Laxdale Ltd
Kings Park House
Laurelhill Business Park
Polmaise Road
FK7 9JQ
Stirling
United Kingdom |
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Telephone:
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+44 (0)1786 476001 |
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Email:
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hmurck@laxdale.co.uk |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 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
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Depression
Mental and Behavioural Disorders
Depressive episode
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Intervention(s)
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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(s)
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Not provided at time of registration
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Secondary Outcome(s)
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Not provided at time of registration
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Secondary ID(s)
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LA01.01.0008A
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Source(s) of Monetary Support
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Laxdale Ltd (UK)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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