Schizophrenia, schizoaffective disorder or first episode psychosis
Conditions
Interventions
Trade Name: Saxenda
Product Name: Saxenda
Pharmaceutical Form: Injection
INN or Proposed INN: LIRAGLUTIDE
CAS Number: 204656-20-2
Sponsors
Southern Health NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
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 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) . 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 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. ; 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. ;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
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Secondary outcomes will be measured at baseline, 12 weeks and, 26 weeks. ; 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. | — |
Countries
United Kingdom
Outcome results
None listed