Treatment on Iatrogenic Weight Gain and Dyslipidaemia Associated With Olanzapine (GWMD09126)
|ClinicalTrials.gov Identifier: NCT01491490|
Recruitment Status : Terminated (The Chief Investigator and the Sponsor have concluded that it will not be possible to complete the enrolment in any meaningful timeframe.)
First Posted : December 14, 2011
Results First Posted : November 1, 2013
Last Update Posted : September 18, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: GWP42003 : GWP42004 (40:1) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Randomised, Doubleblind,Placebo Controlled, Parallel Group, Pilot Study of 40:1 Ratio of Formulated GW42003 :GW42004 in the Treatment of Iatrogenic Weight Gain and Dyslipidaemia Associated With Olanzapine Treatment in Subjects With Functional Psychosis|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
|Active Comparator: GWP42003 : GWP42004 (40:1)||
Drug: GWP42003 : GWP42004 (40:1)
Capsules taken once a day for 6 weeks
|Placebo Comparator: Placebo||
Capsules taken once a day for 6 weeks
- Change in Bodyweight. [ Time Frame: 6 weeks from Baseline. ]Efficacy of a 40:1 ratio of GWP42003:GWP42004 compared with placebo in the change from baseline in body weight after 42 days (6 weeks) in subjects currently being treated with olanzapine for schizophrenia or other non-affective psychosis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01491490
|Birmingham, United Kingdom|
|Leicester, United Kingdom|
|Oxford, United Kingdom|
|South London, United Kingdom|
|Surrey, United Kingdom|
|West London, United Kingdom|
|Principal Investigator:||PI||South London|
|Principal Investigator:||PI||West London|