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

ISRCTN	ISRCTN38354847
DOI	https://doi.org/10.1186/ISRCTN38354847
Secondary identifying numbers	LA01.01.0006

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet
Scientific title	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
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	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 12-month open-label phase receiving 1 g/day ethyl EPA.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Ethyl eicosapentaenoate
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/2003
Completion date	01/01/2004

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	75 Years
Sex	Both
Target number of participants	Not provided at time of registration
Key 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
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

Laxdale Ltd (UK)
Industry

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

Industry

Laxdale Ltd (UK)

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

18/10/2016: No publications found, verifying study status with principal investigator.