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

ISRCTN	ISRCTN44366049
DOI	https://doi.org/10.1186/ISRCTN44366049
Secondary identifying numbers	LA01.01.0002

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	Multicentre double-blind randomised parallel-group placebo-controlled dose-ranging pilot study
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, dose ranging pilot study of 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	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.
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	01/01/2002
Completion date	31/12/2002

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	65 Years
Sex	Both
Target number of participants	Not provided at time of registration
Key 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
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/2002
Date of final enrolment	31/12/2002

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.