|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ISRCTN |
|
Last refreshed on:
|
13 January 2015 |
|
Main ID: |
ISRCTN44218911 |
|
Date of registration:
|
01/07/2001 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
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:
|
|
|
Date of first enrolment:
|
01/06/2000 |
|
Target sample size:
|
0 |
|
Recruitment status: |
Completed |
|
URL:
|
http://isrctn.com/ISRCTN44218911 |
|
Study type:
|
Interventional |
|
Study design:
|
Randomised controlled trial (Treatment)
|
|
Phase:
|
|
|
|
Countries of recruitment
|
|
United Kingdom
| | | | | | | |
|
Contacts
|
|
Name:
|
Harald
Murck |
|
Address:
|
Laxdale Ltd
Kings Park House
Laurelhill Business Park
Polmaise Road
FK7 9JQ
Stirling
United Kingdom |
|
Telephone:
|
+44 (0)1786 476001 |
|
Email:
|
hmurck@laxdale.co.uk |
|
Affiliation:
|
|
|
|
Name:
|
|
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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
Exclusion criteria: Not provided at time of registration
Age minimum:
Age maximum:
Gender:
Both
|
|
Health Condition(s) or Problem(s) studied
|
Schizophrenia
Mental and Behavioural Disorders
Schizophrenia
|
|
Intervention(s)
|
|
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(s)
|
|
Not provided at time of registration
|
|
Secondary Outcome(s)
|
|
Not provided at time of registration
|
|
Secondary ID(s)
|
|
LA.01.01.0001
|
|
Source(s) of Monetary Support
|
|
Laxdale Ltd (UK)
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|