The use of liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis: Results of a pilot randomized, double-blind, placebo-controlled trial.

AIM: To investigate the feasibility and acceptability of using liraglutide 3.0 mg daily in the management of overweight and obesity in people with schizophrenia, schizoaffective disorder and first episode psychosis. MATERIALS AND METHODS: A double-blind, randomized, placebo-controlled pilot trial took place in mental health centres and primary care within Southern Health NHS Foundation Trust. The participants were adults with schizophrenia, schizoaffective or first-episode psychosis prescribed antipsychotic medication who were overweight or obese. The intervention was once-daily subcutaneous liraglutide or placebo, titrated to 3.0 mg daily, for 6 months. The primary outcomes were recruitment, consent, retention and adherence. The secondary exploratory outcomes were weight, HbA1c and Brief Psychiatric Rating Scale. RESULTS: Seven hundred and ninety-nine individuals were screened for eligibility. The most common 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 most commonly stated reason why eligible candidates declined to participate related to the study-specific medication and protocol (n = 50). Forty-seven participants were randomized, with 79% completing the trial. Participants in the liraglutide arm lost a mean 5.7 ± 7.9 kg compared with no significant weight change in the placebo group (treatment difference -6.0 kg, p = .015). Body mass index, waist circumference and HbA1c were reduced in the intervention group. CONCLUSIONS: This study supports the need for a larger randomized controlled trial to evaluate the use of liraglutide (maximum dose 3.0 mg daily) in the management of obesity in people with severe mental illness.