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interventions for preventing weight gain including those currently licensed for weight loss, an off‐label therapy, withdrawn from the market, or an isolated nutritive supplement Samidorphan ‐ standalone + combination therapy with olanzapine Pharmacological adjunct plus behavioural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 |