Antipsychotic induced weight gain in first episode psychosis Mental and Behavioural Disorders
Conditions
Interventions
Intervention: Modified release (MR) metformin tablets and usual care. Dose titrated to reduce side effects. Tablets will be commenced at 500mg daily orally with food, increasing by 500mg daily every 1
Sponsors
Pennine Care NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
16 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Adults with FEP (age =18 yrs <65 yrs) 2. Within 4 weeks of starting any APs 3. Intention to continue AP drugs for =1 year
Exclusion criteria
Exclusion criteria: 1. Body Mass Index (BMI) < 18.5 kg/m² 2. Current prescription of metformin 3. Contraindication to the use of metformin (as advised by the SmPC and British National Formulary (BNF)): chronic stable heart failure, concomitant use of drugs that can acutely impair renal function, renal dysfunction (eGFR <30mL/minute/1.73m2.), significant liver disease with increased likelihood of tissue hypoxia, hypersensitivity or previous intolerance to metformin 4. Any diabetes mellitus 5. Other condition that would independently affect body weight, e.g. Cushing’s syndrome, untreated thyroid dysfunction 6. Current engagement in any systematic weight management programme (or within the past 3 months). Including the use of GLP-1 receptor agonists and GLP-1 receptor GIP dual agonists 7. Any concomitant physical or mental condition that according to the investigator’s assessment makes the participant unsuitable for trial participation 8. Lack of capacity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight (kg) measured using calibrated scales at baseline and 1 year post randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Weight is measured using calibrated scales at baseline, 3 months, 6 months, 9 months, and 12 months 2. Body Mass Index (BMI) is calculated from height and weight measurements using calibrated scales at baseline, 3 months, 6 months, 9 months, and 12 months 3. Proportion of participants who have gained more than 5% and 10% of their baseline body weight is assessed using weight measurements at 12 months 4. Proportion of participants with BMI =25 kg/m² and BMI =30 kg/m² is assessed using BMI calculations at 12 months 5. Change in BMI category is assessed using BMI calculations at baseline and 12 months 6. Waist circumference is measured using a tape measure at baseline, 3, 6 and 9 months 7. Lipid profile (total cholesterol, HDL, LDL, triglycerides), HbA1c, and vitamin B12 are measured using venous blood samples at baseline and 12 months (all), and at 3 and 6 months (lipid profile and HBA1c) 8. Adverse events are recorded by site staff using the METRIC Adverse Event CRF. Site staff will check for adverse events at each study visit (baseline, 3, 6, 9, 12, 15 and 18 months). Events identified outside of study visits at routine care appointments will also be recorded. 9. Mental health status is measured using the Clinical Global Impressions Scale (CGI) at 3, 6 and 12 months. 10. Medication adherence is measured using pill counts for metformin/placebo and clinician survey for antipsychotic medication at 3, 6, 9 and 12 months. 11. Quality of life is measured using the Recovering Quality of Life questionnaire (ReQoL-10) at baseline, 3, 6 and 12 months. 12. Health-related quality of life is measured using the EQ-5D-5L questionnaire at baseline, 3, 6 and 12 months. 13. Health resource use is measured using the METRIC healthcare resource use form at baseline, 3, 6 and 12 months. 14. Cost effectiveness is assessed using via an embedded health economic analysis. 15. Weight is measured using calibrated scales at 12 months and 18 months to assess the effect of w | — |
Countries
England, United Kingdom
Contacts
Public ContactSienna Hamer-Kiwacz
Outcome results
None listed