1.1 Current evidence on the safety and efficacy of vagus nerve stimulation (VNS) for treatment-resistant depression is inadequate in quantity and quality. Therefore this procedure should be used only with special arrangements for clinical governance, consent and audit or research. It should be used only in patients with treatment-resistant depression.
1.2 Clinicians wishing to undertake VNS for treatment-resistant depression should take the following actions.
Inform the clinical governance leads in their Trusts.
Ensure that patients and/or their parents/carers understand the uncertainty about the procedure's safety and efficacy and provide them with clear written information. In addition, the use of NICE's information for patients ('Understanding NICE guidance') is recommended.
Audit and review clinical outcomes of all patients having VNS for treatment-resistant depression (see section 3.1).
1.3 Patient selection and management should be carried out by a multidisciplinary team including a psychiatrist and a surgeon (usually a neurosurgeon), with other relevant specialists (for example, a clinical psychologist and an appropriately trained technician).
1.4 NICE encourages further research into VNS for treatment-resistant depression. Research outcomes should include depression rating scales, objective measures of depressive symptoms and patient-reported quality of life. NICE may review the procedure on publication of further evidence.