Conditions: Schizophrenia
Keywords: Schizophrenia Functional psychosis Schizophreniform Acute psychosis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: GWP42003 : GWP42004 (40:1) intervention 2: Placebo
Intervention descriptions: intervention 1: Capsules taken once a day for 6 weeks intervention 2: Capsules taken once a day for 6 weeks

Protocol document: