A multicentre, double-blind, randomised, parallel group, placebo-controlled trial of LAX-101 (ethyl eicosapentaenoate [EPA]) as adjunct therapy in patients who remain depressed following treatment with standard antidepressant therapy

Not Applicable

Completed

• Conditions: Depression; Mental and Behavioural Disorders; Depressive episode

• Registration Number: ISRCTN38354847
• Lead Sponsor: axdale Ltd (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-02-03
• Last Update Posted: 28 November 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 0

Inclusion Criteria

1. Written informed consent
2. Score of greater than or equal to 16 on the Hamilton Depression Rating Scale (HDRS)
3.Treatment for greater than or equal to 8 weeks with one or more standard antidepressant, at stable dose for greater than or equal to 3 weeks
4. Currently receiving at least the minimum therapeutic dose of one or more standard antidepressant, as defined in the British National Formulary (BNF)
5. Diagnosis of major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth edition [DSM-IV])
6. Male or female of any race aged 18-75

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ot provided at time of registration

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration