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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN38354847
Enrollment
Unknown
Registered
2003-02-03
Start date
2003-01-01
Completion date
Unknown
Last updated
2016-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression Mental and Behavioural Disorders Depressive episode

Interventions

Two groups randomly allocated to: 1. Placebo 2. 1 g/day ethyl EPA on a double-blind basis. Patients who completed the 12-week randomisation phase of the trial were invited to take part in a further

Sponsors

Laxdale Ltd (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026