Methods

Participants

Interventions

Outcomes

Notes

Allocation: randomised ‐ clearly described.
Blindness: double ‐ described and tested.
Duration: 6 months.
Design: parallel.
Setting: hospital/community.
Consent: described.
Loss: described.

Diagnosis: neuroleptic‐induced akathisia ‐ defined by clinically relevant criteria.
N=300.*
Age: any.
Sex: any.

1. Anitcholinergic used in everyday practice, for example bentropine + standard care. N=150.
2. Placebo + standard care. N=150.

Death.
Clinically important improvement in akathisia.**
Adverse effects.
Acceptability of treatment.
Leaving the study early.
Quality of life.
Economic data.

* Size of study with sufficient power to highlight about a 10% difference between groups for primary outcome.

** Predefined binary outcome, even if scale‐defined.