GWMD09126 - GWP42003:GWP42004 Olanzapine weight gain treatment

• Research type

  Research Study

• Full title

  A randomised, double-blind, placebo-controlled parallel group, pilot study of 40:1 ratio of formulated GWP42003 : GWP42004 in the treatment of iatrogenic weight gain and dyslipidaemia associated with olanzapine or other antipsychotic(s) treatment in subjects with schizophrenia or other non-affective psychosis

• IRAS ID

  76764

• Contact name

  GW Pharma Ltd Switchboard

• Sponsor organisation

  GW Pharma Ltd

• Eudract number

  N/A

• ISRCTN Number

  N/A

• Research 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 cannabinoids GW42004 and GW42003 as a 1:40 ratio when combined with 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 in a 1:1 ratio. In order to be eligible for enrolment 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 documented evidence of 2% 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 a further 2% 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.

• REC name

  East Midlands - Leicester Central Research Ethics Committee

• REC reference

  11/EM/0093

• Date of REC Opinion

  12 Jul 2011

• REC opinion

  Further Information Favourable Opinion