A multicentre, double-blind, randomised, parallel group, placebo-controlled, dose-ranging pilot study of ethyl-eicosapentaenoate (ethyl-EPA) in patients with schizophrenia
| ISRCTN | ISRCTN44218911 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44218911 |
| Secondary identifying numbers | LA.01.01.0001 |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 07/09/2007
- 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
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) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Schizophrenia |
| Intervention | 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. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Ethyl-eicosapentaenoate (ethyl-EPA) |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/06/2000 |
| Completion date | 01/06/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Not provided at time of registration |
| Key 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 |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/2000 |
| Date of final enrolment | 01/06/2001 |
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
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/01/2002 | Yes | No |
