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

INTERVENTION: Trade Name: Saxenda Product Name: Saxenda Pharmaceutical Form: Injection INN or Proposed INN: LIRAGLUTIDE CAS Number: 204656‐20‐2 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 6.0‐ Pharmaceutical form of the placebo: Injection Route of administration of the placebo: Subcutaneous use Product Name: Placebo Pharmaceutical Form: Injection CONDITION: Schizophrenia, schizoaffective disorder or first episode psychosis Therapeutic area: Psychiatry and Psychology [F] ‐ Mental Disorders [F03] PRIMARY OUTCOME: ; Primary end point(s): The primary objective is to evaluate the feasibility and acceptability of delivering a full scale trial evaluating treatment with liraglutide in people with schizophrenia, including those with first episode psychosis.; ; We will collect data on:; ; 1. Time to recruitment target; ; 2. Number and key characteristics of eligible patients approached for the study; ; 3. Reasons why eligible candidates refused to take part or agreed to take part.; ; 4. Adherence to study medication; ; 5.Participant attrition rate, defined as the number of participants not available for follow up as per the research protocol.; ; 6.Reasons why participants withdrew from the research protocol.; ; 7.Qualitative information from participants and mental health workers about recruitment, acceptability and satisfaction with the intervention.; ; 8.The number of missing values, and the number of incomplete cases.; Main Objective: The practicalities and acceptability of delivering a large scale trial looking at treatment with liraglutide in people with severe mental illness (schizophrenia, schizoaffective disorder and first episode psychosis.) Secondary Objective: To compare the effects of liraglutide 3 mg once daily versus placebo on body weight after 26 weeks. Timepoint(s) of evaluation of this end point: This data will be collected throughout the trial and up until a maximum of two weeks after the trial ends. SECONDARY OUTCOME: ; Secondary end point(s): 1.Weight;; 2.Proportion who maintained or reduced weight;; 3.Proportion of participants with 5% weight loss; 4.Waist circumference;; 5.Body Mass Index;; 6.Blood pressure;; 7.Fasting plasma glucose, lipid profile, HbA1c;; 8.Brief Psychiatric Rating Scale;; 9.Smoking status;; 10.Adverse events.; Timepoint(s) of evaluation of this end point: Secondary outcomes will be measured at baseline, 12 weeks and, 26 weeks. 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