GWMD09126 - GWP42003:GWP42004 antipsychotic(s) weight gain treatment

• Conditions: Iatrogenic weight gain and dyslipidaemia associated with treatment using antipsychotic medication; MedDRA version: 14.1Level: LLTClassification code 10047896Term: Weight gainSystem Organ Class: 10022891 - Investigations; MedDRA version: 14.1Level: LLTClassification code 10058110Term: DyslipidemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2011-000180-28-GB
• Lead Sponsor: GW Pharma Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04-11
• Last Update Posted: 22 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

For inclusion in the study subjects must fulfil ALL of the following criteria:
- Willing and able to give informed consent for participation in the study.
- Subject is aged 18 years or above.
- Diagnosis (DSM-IV-TR) of schizophrenia, or other non-affective psychosis.
- Receiving at least one antipsychotic.
- The dose of antipsychotic(s) is stable for at least 2 weeks prior to randomisation (Visit 2).
- Subject is willing to maintain a stable dose of antipsychotic(s) for the duration of the study.
- Evidence of recent weight gain attributable to antipsychotic treatment (in the opinion of the Investigator), prior to screening (Visit 1). Wherever possible, investigator must exclude other possible causes of weight gain, such as change in exercise, diet , concomitant medications or other illnesses.
- Each subject must have a further documented 2% weight gain attributable to antipsychotic treatment in the baseline period (between Visits 1 and 2).
- Willing to maintain a stable dose of any concomitant medications (excluding PRN medicines at the Investigator’s discretion), and have been on a stable dose for a minimum of 6 weeks prior to screening (Visit 1) (with the exception of antipsychotic(s)).
- 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).
- Capable of complying with the study requirements and completing the study (in the opinion of the investigator).
-Willing to allow his or her primary care practitioner and consultant, if appropriate, to be notified of participation in the study.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 57
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 3

Exclusion Criteria

The subject may not enter the study if ANY of the following apply:
- Subject has Axis I (DSM-IV-TR) 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.
- 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 = 19 (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 subject who is pregnant, lactating or planning pregnancy during the course of the study and for 3 months from the date of last dose.
- Female subjects of child bearing potential, unless willing to use two forms of contraception, one of which must be a barrier contraception (e.g. Female condom of occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for 3 months from the date of last dose (however a male condom should not be used in conjunction with the female condom).
- Male subjects whose partner is of child bearing potential, unless willing to use an appropriate barrier method of contraception (condom and spermicide) in addition to having their female partner use another form of barrier contraception (e.g. occlusive cap (diaphragm or cervical vault/caps) with spermicide) during the study and for 3 months from date of last dose (however a male condom should not be used in conjunction with a female condom).
- Received an Investigational Medicinal Product within the 90 days before the screening visit (Visit 1).
- In the opinion of the investigator, is not considered to be suitable for the study.
- Poor compliance as observed during screening period.
- Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, influence the result of the study, or the subject's ability to participate in the study.
- Any abnormalities identified during the physical examination at Visit 1 that in the opinion of the investigator would prevent the subject from safe participation in the study.
- Unwilling to abstain from donation of blood during the study.
- Previously randomised into this study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified