Liraglutide and the management of overweight and obesity in people with schizophrenia: a pilot study

Study ID: 37638
Short Title: L.O.S.E Weight Version 1.0
Organisation: Southern Health NHS Foundation Trust
Location: Moorgreen Hospital
Condition: Psychosis - schizophrenia
Main Specialty: Mental Health
Expected End Date: 31/01/2020
Postcode: SO30 3JB
Contact Name: R&D department
Contact Email:
Active: Yes

Inclusion Criteria

1)Age 18-75 years old. 2)Clinical diagnosis of schizophrenia or schizoaffective disorder (defined by ICD-10 codes F20 and F25) or first episode psychosis using case note review. There is no limit on the duration of illness for those with schizophrenia or schizoaffective disorder but first episode psychosis is defined as less than 3 years since presentation to the mental health team or first antipsychotic prescription. 3)Treatment with an antipsychotic, with a minimum duration of 1 month prior to entry in to the trial. No restriction is placed on the class or generation of antipsychotic 4)Ability to give written informed consent. 5)Ability and willingness to take liraglutide or placebo. 6)Ability to speak and read English. 7)Body mass index > = 30 kg/m² (obese), or > = 27 kg/m² to < 30 kg/m² (overweight) in the presence of at least one weight-related consequence such as dysglycaemia (HbA1c > 42 mmol/mol), hypertension (blood pressure > 140/90 mmHg), dyslipidaemia (record of dyslipidaemia and/or taking lipid lowering drugs) or obstructive sleep apnoea (diagnosis from respiratory physician) .

Exclusion Criteria

1) Physical illnesses that could seriously reduce their life expectancy or ability to participate in the trial 2) A co-existing physical health problem that would, in the opinion of the principal investigator, independently impact on metabolic measures or weight, e.g. Cushing’s syndrome , poorly controlled T2DM defined by HbA1c > 8% (64 mmol/mol). 3) Severe renal or hepatic impairment 4) Inflammatory bowel disease and diabetic gastroparesis 5) Contraindications to Saxenda®: Hypersensitivity to liraglutide or to any of the excipients 6) Use of other pharmacological products for weight management 7) Mental illnesses that could seriously reduce their ability to participant in the trial, including significant suicidality. Every patient in contact with the Southern Health Trust has a risk assessment which is recorded on the electronic patient record (RIO). If the risk assessment states that they are at “High” risk of harm to themselves, we would exclude the patient from the study. In addition, prior to recruitment, we will approach any potential participant’s care coordinators to verify the currently recorded risk, to ensure that the risk status has not changed. 8) Current pregnancy or a desire to become pregnant. Mothers who are less than 6 months post-partum or breastfeeding will also be excluded. Women who become pregnant during the trial will be advised to stop the study medication and will be withdrawn from the trial. Any women who may become pregnant during the trial but is unwilling to use a highly effective method of birth control (e.g. such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) will not be eligible for the trial. 9) Significant alcohol or substance misuse which, in the opinion of the principal investigator, would limit the patient’s ability to participate in the trial. 10) A diagnosis or tentative diagnosis of psychotic depression or mania. 11) A primary diagnosis of learning disability or cognitive impairment which would impair participant’s ability to self-administer trial medication. 12) Lack of capacity. Those who lose capacity any time during the study will not be eligible to continue and will be withdrawn from the study immediately with no further study procedures carried out. 13) History of type 1 diabetes 14) Current or previous use of incretin based therapies (GLP-1 receptor agonist or DPP-4 inhibitors) or insulin

Study summary:

People with schizophrenia die 10- 20 years earlier than the general population. This is in part due to the fact that they are two times more likely to be overweight. Lifestyle interventions have not been shown to be effective for this population in NHS settings. The drug liraglutide is similar to a hormone (glucagon-like peptide 1) which suppresses appetite. It has recently been licensed at a high dose (3 mg) as a once daily injectable therapy for overweight and obesity. We will invite people with schizophrenia, schizoaffective disorder or first episode psychosis (age > 18 years) from community and inpatient mental health settings in Southern Health NHS Foundation Trust. To be eligible for the trial participants must have been on antipsychotic medication for a minimum of one month and be either obese (body mass index (BMI) > 30 kg/m²) or be overweight (BMI > = 27 kg/m² to < 30 kg/m²) and have at least one weight related comorbidity. Eligible participants will be randomised to either liraglutide 3mg each day or placebo once confirmed that they can take part in the trial after their screening visit. The study will then consist a 26 week treatment period. Up-titration of the medication will be over 4 weeks done over the phone or in person. Study data will be collected at baseline, 12 and 26 weeks. The main aim of the study is to gather data on recruitment, consent, retention, adherence and dropout rates. Qualitative interviews with a sub-sample of invention-arm participants and healthcare workers will provide data on the practicality and acceptability of liraglutide. Clinical outcome measures will include weight (kilogram) change at 26 weeks and the number that therefore maintained or reduced weight. If an effect size is seen this would be used to calculate the number of participants needed to power a definitive trial.

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