Treatment on Iatrogenic Weight Gain and Dyslipidaemia Associated With Olanzapine
Status:
Terminated
Trial end date:
2012-10-01
Target enrollment:
Participant gender:
Summary
Olanzapine is one of the most effective and best tolerated of the atypical antipsychotics,
but it is also particularly associated with weight gain and metabolic problems.
This study is being conducted by GW Pharma Ltd as a pilot study in order to determine the
efficacy and safety of two medications GW42003 and GW42004 as a 40:1 ratio when combined with
the subjects existing treatment of olanzapine in subjects with weight gain attributable to
olanzapine treatment for functional psychosis. This is the first study to determine whether
the study medications have a positive benefit for subjects on their cholesterol levels, body
weight and other metabolic parameters, as well as a potential augmentation of the
anti-psychotic effect of olanzapine.
This is a multi-centre randomised, double-blind, placebo-controlled, parallel-group pilot
study. There will be two groups of subjects (GWP42003 plus GWP42004 (40:1 ratio) and
placebo), with a treatment duration of 6 weeks as well as a baseline period of variable
length and one week follow-up. The two treatment groups will be randomised equally.
In order to be eligible for enrollment in this study, subjects will need to be aged 18 years
and above and be clinically diagnosed with functional psychosis and receiving olanzapine
treatment for no more than 3 months with evidence of weight gain attributable to olanzapine
treatment.
Eligible subjects will enter the study at a screening visit (Visit 1) and commence a baseline
period. Subjects will also be assessed at Visit 2 for further weight gain during the baseline
period. The baseline period is flexible in length to allow time for this weight gain to be
achieved and also for the olanzapine dose to be stabilised. If eligible the subject will be
randomised into the 6-week treatment phase. There are a total of 6 visits in the study.