| Source of record | UK Trials |
| ISRCTN | ISRCTN44218911 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LA.01.01.0001 |
| Public title | A multicentre, double-blind, randomised, parallel group, placebo-controlled, dose-ranging pilot study of ethyl-eicosapentaenoate (ethyl-EPA) in patients with schizophrenia |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Schizophrenia |
| 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. Diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
3. Minimum duration of 12 weeks from diagnosis
4. Maximum duration of 20 years from diagnosis
5. Maintained on same neuroleptic drug(s) for 12 weeks and on the same dose for 4 weeks
6. Total Positive and Negative Syndrome Scale (PANSS) score of 50 or more and a positive sub-scale PANSS score of 15 or more
7. Aged 18 - 65 of either sex
8. In-patient or out-patient |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/06/2000 |
| Anticipated end date | 01/06/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Four groups were randomly allocated to placebo or 1 g, 2 g or 4 g ethyl-EPA/day on a double blind basis. Treatment duration 12 weeks. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=11755456 |
| Sources of funding | Laxdale Ltd (UK) |
| Sponsor name | Laxdale Ltd (UK) |
| Sponsor details | Kings Park House
Laurelhill Business Park
Polmaise Road
Stirling
United Kingdom
FK7 9JQ |
| Sponsor website | http://www.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 | ISRCTN44218911 |
| Date last extracted from ISRCTN register | 17/04/2008 |
