Condition category
Mental and Behavioural Disorders
Date applied
03/02/2003
Date assigned
03/02/2003
Last edited
18/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.laxdale.co.uk

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

Publication citations

Additional files

Editorial Notes

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