| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN38354847 |
| Date ISRCTN assigned | 03/02/2003 |
| Local reference number(s) | LA01.01.0006 |
| Public 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 |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Depression |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Laxdale Ltd |
| Sponsor name | Laxdale Ltd |
| Sponsor details | Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
United Kingdom
FK7 9JQ |
| Sponsor telephone | +44 (0)1786 476001 |
| Sponsor fax | +44 (0)1786 473137 |
| Sponsor email | admin@Laxdale.co.uk |
| Contact name | Dr Harald Murck |
| Contact details | Laxdale Ltd
Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
United Kingdom
FK7 9JQ |
| Contact telephone | +44 (0) 1786 476001 |
| Contact fax | +44 (0) 1786 473137 |
| Contact email | hmurck@laxdale.co.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN38354847 |
| Date last extracted from ISRCTN register | 17/04/2008 |
