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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN44366049
Enrollment
Unknown
Registered
2002-02-26
Start date
2002-01-01
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 Depression

Interventions

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.

Sponsors

Laxdale Ltd (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

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