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Health Condition(s) or Problem
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Schizophrenia
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Lay Summary
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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 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.
(from ClinicalTrials.gov)
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Who can enter the trial
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Inclusion Criteria:
- Diagnosis (DSM-IV) of schizophrenia or functional psychosis including
schizophreniform and acute psychosis with schizophrenia symptoms
- Receiving olanzapine treatment for no more than 3 months
- The dose of olanzapine is stable for at least 2 weeks prior to randomisation (Visit
2) and subject is willing to maintain a stable dose of olanzapine for the duration of
the study
- Evidence of weight gain in the last 3 months attributable to olanzapine, prior to
screening (Visit 1). Wherever possible, investigator must exclude other possible
causes of weight gain, such as change in exercise, diet, or other illnesses
- Each subject must have further weight gain attributable to olanzapine, in the
baseline period (between Visits 1 and 2) no more than 5 months subsequent to
commencement of olanzapine treatment
- Willing to maintain a stable dose of any concomitant medications, and have been on a
stable dose for a minimum of 6 weeks (with the exception of olanzapine)
- No changes in diet or exercise for 6 weeks prior to screening (Visit 1) and subject
agrees to maintain stability, for the duration of the study (in the opinion of the
investigator)
Exclusion Criteria:
- Subject has Axis I (DSM-IV) diagnosis of schizoaffective disorder;
- Subject has drug induced or toxic psychosis (in the opinion of the investigator)
- Subject presents with a clinical picture and/ or history that is consistent with
delirium, dementia, amnesia or other cognitive disorder; bipolar disorder or major
depression
- Subject has a significant history of anxiety, suicidal ideation or self-harm based on
history or routine psychiatric status examination (in the opinion of the
investigator)
- Subject has an unstable thyroid pathology (including hypo or hyperthyroidism), within
the past six months (in the opinion of the investigator)
- Subject has a history of neuroleptic malignant syndrome;
- Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2 month
period prior to randomisation (Visit 2)
- Subject has a clinical diagnosis of diabetes
- Subject is taking insulin (i.e. they are insulin dependent) or have had insulin
within 6 months prior to the screening visit (Visit 1);
- Any known or suspected history of (in the opinion of the investigator):
- alcohol or substance abuse
- epilepsy or recurrent seizures
- Any known or suspected history of depression sufficient to require treatment or
disrupt ordinary life (excluding episodes of reactive depression - in the opinion of
the investigator)
- BDI Score = 15 (at Visit 1 or 2)
- Clinically significant cardiac, renal or hepatic impairment in the opinion of the
investigator
- Genetic dyslipidaemic condition in the opinion of the investigator
- Female patients of child-bearing potential and male patients whose partner is of
child-bearing potential, unless willing to ensure that they or their partner use
effective contraception, for example, oral contraception, double barrier,
intra-uterine device, during the study and for three months thereafter (however, a
male condom should not be used in conjunction with a female condom as this may not
prove effective)
- Travel outside the country of residence planned during the study treatment period
- Having received olanzapine treatment continuously for more than 3 months prior to
screen
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Who cannot enter the trial
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Inclusion Criteria:
- Diagnosis (DSM-IV) of schizophrenia or functional psychosis including
schizophreniform and acute psychosis with schizophrenia symptoms
- Receiving olanzapine treatment for no more than 3 months
- The dose of olanzapine is stable for at least 2 weeks prior to randomisation (Visit
2) and subject is willing to maintain a stable dose of olanzapine for the duration of
the study
- Evidence of weight gain in the last 3 months attributable to olanzapine, prior to
screening (Visit 1). Wherever possible, investigator must exclude other possible
causes of weight gain, such as change in exercise, diet, or other illnesses
- Each subject must have further weight gain attributable to olanzapine, in the
baseline period (between Visits 1 and 2) no more than 5 months subsequent to
commencement of olanzapine treatment
- Willing to maintain a stable dose of any concomitant medications, and have been on a
stable dose for a minimum of 6 weeks (with the exception of olanzapine)
- No changes in diet or exercise for 6 weeks prior to screening (Visit 1) and subject
agrees to maintain stability, for the duration of the study (in the opinion of the
investigator)
Exclusion Criteria:
- Subject has Axis I (DSM-IV) diagnosis of schizoaffective disorder;
- Subject has drug induced or toxic psychosis (in the opinion of the investigator)
- Subject presents with a clinical picture and/ or history that is consistent with
delirium, dementia, amnesia or other cognitive disorder; bipolar disorder or major
depression
- Subject has a significant history of anxiety, suicidal ideation or self-harm based on
history or routine psychiatric status examination (in the opinion of the
investigator)
- Subject has an unstable thyroid pathology (including hypo or hyperthyroidism), within
the past six months (in the opinion of the investigator)
- Subject has a history of neuroleptic malignant syndrome;
- Subject requires or has had electroconvulsive therapy (ECT) treatment in the 2 month
period prior to randomisation (Visit 2)
- Subject has a clinical diagnosis of diabetes
- Subject is taking insulin (i.e. they are insulin dependent) or have had insulin
within 6 months prior to the screening visit (Visit 1);
- Any known or suspected history of (in the opinion of the investigator):
- alcohol or substance abuse
- epilepsy or recurrent seizures
- Any known or suspected history of depression sufficient to require treatment or
disrupt ordinary life (excluding episodes of reactive depression - in the opinion of
the investigator)
- BDI Score = 15 (at Visit 1 or 2)
- Clinically significant cardiac, renal or hepatic impairment in the opinion of the
investigator
- Genetic dyslipidaemic condition in the opinion of the investigator
- Female patients of child-bearing potential and male patients whose partner is of
child-bearing potential, unless willing to ensure that they or their partner use
effective contraception, for example, oral contraception, double barrier,
intra-uterine device, during the study and for three months thereafter (however, a
male condom should not be used in conjunction with a female condom as this may not
prove effective)
- Travel outside the country of residence planned during the study treatment period
- Having received olanzapine treatment continuously for more than 3 months prior to
screen
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What will happen
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Drug; GWP42003 : GWP42004 (40:1); Capsules taken once a day for 6 weeks; GWP42003 : GWP42004 (40:1); Drug; Placebo; Capsules taken once a day for 6 weeks; Placebo
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Primary aim
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Total body weight change.
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Secondary Aim
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Body Fat Parameters change; Baseline to end of treatment(Week 6).; No; Change from baseline in :
Skin fold measurements
Waist to hip ratio; Lipid Parameters change; Baseline to end of treatment (Week 6).; No; Change from baseline in :
Cholesterol
Triglycerides
Apolipoprotein markers
Free fatty acids; Glucose Control change; Baseline to end of treatment (Week 6).; No; Change from baseline in :
Fasting plasma glucose
HbA1c; Insulin Control change; Baseline to end of treatment (Week 6).; No; Change from baseline in :
*Fasting insulin; Psychiatric/Clinical Assessments change; Baseline to end of treatment (Week 6).; No; Change from baseline in the following assessments :
PANSS
GAF
BDI
UMACL
SAS
CGIC; Hormonal Marker change; Baseline to end of treatment (Week 6).; No; Change from baseline in :
*Serum prolactin; Inflammation Markers change; Baseline to end of treatment (Week 6).; No; Change from baseline in :
CRP
Cytokines; Adipocyte Function Markers change; Baseline to end of treatment (Week 6).; No; Change from baseline in :
Leptin
Adiponectin; Appetite Assessment change; Baseline to end of treatment (Week 6).; No; Change from baseline in :
*Appetite Normal Rating Scale score; Safety and Tolerability; Baseline to end of treatment (Week 6).; Yes; Safety and Tolerability will be assesed by reviewing the results of the parameters detailed below:
incidence, type and severity of all adverse events reported
vital signs
ECG
laboratory and physical examination for the 40:1 ratio of GWP42003 : GWP42004 compared with placebo:
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Participant Information Sheet
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Sorry, not currently available
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Website
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Sorry, not currently available
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Recruitment Status
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Stopped
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Nation
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England
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Location
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Birmingham, Leicester, Oxford, London, Surrey
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