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. 2022 Oct 3;2022(10):CD013337. doi: 10.1002/14651858.CD013337.pub2

1. Suggested design for future studies.

Methods Randomisation: random
Allocation: concealed
Blinding: double‐blind
Duration: 12 months
Setting: inpatients or outpatients
Participants Diagnosis: patients with schizophrenia, or any schizophrenia‐like illness
Gender: male and female
Age: mean 30 years, range: 18‐65 (adult population)
Interventions Pharmacological interventions for preventing weight gain including those currently licensed for weight loss, an off‐label therapy, withdrawn from the market, or an isolated nutritive supplement
Samidorphan ‐ standalone + combination therapy with olanzapine
Pharmacological adjunct plus behavioural intervention versus behavioural intervention alone
Outcomes Clinically important change in weight (e.g. binary outcomes such as ≥ 7% weight loss)
Clinically important change in BMI
Waist‐to‐hip ratio
Notes Look at effects of factors such as stage of illness and ethnicity
Dose effects
BMI: body mass index