Materials and Methods
Design: Double‐blind, randomised, placebo‐controlled pilot trial.
Setting: Mental health centres and primary care within Southern Health NHS Foundation Trust.
Participants: Adults with schizophrenia, schizoaffective, or first‐episode psychosis prescribed antipsychotic medication who were overweight or obese.
Intervention: Once daily subcutaneous liraglutide or placebo, titrated to 3.0 mg daily, for 6 months.
Primary outcome: recruitment, consent, retention and adherence.
Secondary exploratory outcomes: weight, HbA1c and Brief Psychiatric Rating Scale.
Results: 799 individuals were screened for eligibility. The commonest reasons for exclusion were ineligibility (44%) and inability to make contact (28%). The acceptance rate, as a proportion of all eligible participants, was 12.2%. The commonest stated reason why eligible candidates declined to participate related to the study specific medication and protocol (n= 50). 47 participants were randomised with 79% completing the trial. Participants in the liraglutide arm had lost a mean 5.7±7.9 kg compared with no significant weight change in the placebo group (treatment difference −6.0 kg, p=0.015). BMI, waist circumference and HbA1c reduced in the intervention group.
Conclusions: This study supports the need for a larger randomised controlled trial to evaluate use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with severe mental illness.
- severe mental illness