Contact information
Type
Scientific
Primary contact
Dr Harald Murck
ORCID ID
Contact details
Laxdale Ltd
Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
FK7 9JQ
United Kingdom
+44 (0)1786 476001
hmurck@laxdale.co.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
LA01.01.0006
Study information
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
Acronym
Study hypothesis
Not provided at time of registration
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
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
Phase
Not Applicable
Drug names
Ethyl eicosapentaenoate
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/2003
Overall trial end date
01/01/2004
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/2003
Recruitment end date
01/01/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Laxdale Ltd
Stirling
FK7 9JQ
United Kingdom
Sponsor information
Organisation
Laxdale Ltd (UK)
Sponsor details
Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
FK7 9JQ
United Kingdom
+44 (0)1786 476001
admin@Laxdale.co.uk
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Laxdale Ltd (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary