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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Harald Murck
Scientific

Laxdale Ltd
Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
FK7 9JQ
United Kingdom

Phone	+44 (0)1786 476001
Email	hmurck@laxdale.co.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	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
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Depression
Intervention	Four groups randomly allocated to placebo, 0.5 g, 1 g or 2 g/day ethyl EPA on a double-blind basis.
Intervention type	Other
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	01/01/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2003
Date of final enrolment	01/01/2004

Laxdale Ltd

Stirling
FK7 9JQ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

11/10/2016: No publications found, verifying study status with principal investigator.