A multicentre, double-blind, randomised, parallel group, placebo-controlled trial of LAX-101 (ethyl eicosapentaenoate [EPA]) in patients with a new or recurrent episode of depression
| ISRCTN | ISRCTN63565713 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63565713 |
| Secondary identifying numbers | LA01.01.0008A |
- Submission date
- 03/02/2003
- Registration date
- 03/02/2003
- Last edited
- 11/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Dr Harald Murck
Scientific
Scientific
Laxdale Ltd
Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
FK7 9JQ
United Kingdom
| Phone | +44 (0)1786 476001 |
|---|---|
| hmurck@laxdale.co.uk |
Study information
| 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]) in patients with a new or recurrent episode of depression |
| 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, 0.5 g, 1 g or 2 g/day ethyl EPA on a double-blind basis. |
| Intervention type | Other |
| 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 |
Eligibility
| 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. Diagnosis of major depressive disorder (Diagnostic and Statistical Manual of Mental Disorders, Fourth edition [DSM-IV]) 3. Score of between and including 16 and 25 on the Hamilton Depression Rating Scale (HDRS) 4. No treatment with any antidepressant medication (including St John's Wort) in the last 12 weeks from the date of Visit 0 (screen) 5. 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 |
Locations
Countries of recruitment
- Scotland
- United Kingdom
Study participating centre
Laxdale Ltd
Stirling
FK7 9JQ
United Kingdom
FK7 9JQ
United Kingdom
Sponsor information
Laxdale Ltd (UK)
Industry
Industry
Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
FK7 9JQ
United Kingdom
| Phone | +44 (0)1786 476001 |
|---|---|
| admin@Laxdale.co.uk | |
| Website | http://www.laxdale.co.uk |
"ROR" |
https://ror.org/03gc62f43 |
Funders
Funder type
Industry
Laxdale Ltd (UK)
No information available
Results and Publications
| 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 |
Editorial Notes
11/10/2016: No publications found, verifying study status with principal investigator.
