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Notice Summary

Title:
UK-Southampton: 18/194 Vagus Nerve Stimulation for Highly Treatment-Resistant Depression
Document Ref:
GB003ZM281538
Document Type:
Contract Notice - Other
Published By:
National Institute for Health Research
Date Published:
18 December 2018
Deadline Date:
03 April 2019
Document Source:
Framework/DPS:
No
Alert Profile:
Labels:

Notice Abstract

The Health Technology Assessment Programme is accepting stage 1 applications to their commissioned workstream for this primary research topic: 18/194 Vagus nerve stimulation for highly treatment-resistant depression The UK NIHR and the Australian National Health and Medical Research Council (NHMRC) are collaborating on this research priority and will consider joint funding for any collaborative research proposals submitted to this brief. Applications which include a research collaboration between UK and Australian institutions are most welcome. Please refer to the supplementary guidance for additional requirements related to NIHR/NHMRC collaborative applications. Applications from UK institutions without an Australian collaborative element are also welcome for consideration. Rationale: Treatment-resistant depression (TRD) is a major public health concern in terms of individual suffering and cost to the NHS and wider society. Options are currently very limited for individuals with an inadequate response to first- and second-line treatment approaches and there is a real need for effective therapies for this group. Electroconvulsive therapy (ECT) may be offered and has a high initial response rate, but relapse rate is high and there is a risk of cognitive impairment. ECT also has a poor reputation with many service users. VNS is a treatment where a small electrical pulse is administered through an implanted neurostimulator to a wire connected to the left vagus nerve in the neck. VNS is a long-term treatment and an increase in clinical response over months of use has been reported. NICE currently recommends this procedure for adults and children with treatment-resistant epilepsy. However, for people with treatment-resistant depression, NICE states that due to inadequate evidence, the procedure should only be used with special arrangements or in research. Recent Canadian guidelines for depression have recommended VNS as a third-line treatment and the therapy has been FDA approved in the US for many years. VNS is being used in the UK in a few centres. In England, it is currently NHS-funded via the Individual Funding Request mechanism. Numerous non-randomised studies, often with long-term follow-up, have reported that VNS is associated with a significant reduction in depressive symptoms, enduring benefits and high treatment compliance. However, the only RCT failed to find any significant change in depression rating scale, although it did demonstrate significance on its secondary outcome measures. Several reasons for the lack of primary benefit in the RCT (which compared active VNS versus implanted but not turned on VNS) have been discussed by experts but, currently, the positive evidence to date comes from non-randomised or uncontrolled studies. In addition, whilst VNS is viewed as cost-effective for use in epilepsy, the cost-effectiveness for TRD is unknown. A high quality randomised controlled trial is needed to inform clinical practice regarding the use of VNS for TRD and to inform future guidelines. Recognising that a feasibility study will be required to assess the ability of the sham procedure to act as a placebo, a step-wise approach is proposed as outlined above. This is a hard stop-go criterion and applicants will need to take account of this in the design and costings of the study

Notice Details

CONTRACT NOTICE – NATIONAL

SERVICES

1 Authority Details

1.1

Authority Name and Address

National Institute for Health Research
N/A
Southampton UK
N/A N/A
N/A

1.2

Address from which documentation may be obtained

As in 1.1

1.3

Completed documents must be returned to:

As in 1.1

2 Contract Details

2.1

Title

18/194 Vagus Nerve Stimulation for Highly Treatment-Resistant Depression

2.2

Description of the goods or services required

The Health Technology Assessment Programme is accepting stage 1 applications to their commissioned workstream for this primary research topic:

18/194 Vagus nerve stimulation for highly treatment-resistant depression

The UK NIHR and the Australian National Health and Medical Research Council (NHMRC) are collaborating on this research priority and will consider joint funding for any collaborative research proposals submitted to this brief. Applications which include a research collaboration between UK and Australian institutions are most welcome. Please refer to the supplementary guidance for additional requirements related to NIHR/NHMRC collaborative applications. Applications from UK institutions without an Australian collaborative element are also welcome for consideration.

Rationale:

Treatment-resistant depression (TRD) is a major public health concern in terms of individual

suffering and cost to the NHS and wider society. Options are currently very limited for individuals

with an inadequate response to first- and second-line treatment approaches and there is a real

need for effective therapies for this group. Electroconvulsive therapy (ECT) may be offered and

has a high initial response rate, but relapse rate is high and there is a risk of cognitive

impairment. ECT also has a poor reputation with many service users.

VNS is a treatment where a small electrical pulse is administered through an implanted

neurostimulator to a wire connected to the left vagus nerve in the neck. VNS is a long-term

treatment and an increase in clinical response over months of use has been reported. NICE

currently recommends this procedure for adults and children with treatment-resistant epilepsy.

However, for people with treatment-resistant depression, NICE states that due to inadequate

evidence, the procedure should only be used with special arrangements or in research. Recent

Canadian guidelines for depression have recommended VNS as a third-line treatment and the

therapy has been FDA approved in the US for many years. VNS is being used in the UK in a few

centres. In England, it is currently NHS-funded via the Individual Funding Request mechanism.

Numerous non-randomised studies, often with long-term follow-up, have reported that VNS is

associated with a significant reduction in depressive symptoms, enduring benefits and high

treatment compliance. However, the only RCT failed to find any significant change in depression

rating scale, although it did demonstrate significance on its secondary outcome measures.

Several reasons for the lack of primary benefit in the RCT (which compared active VNS versus

implanted but not turned on VNS) have been discussed by experts but, currently, the positive

evidence to date comes from non-randomised or uncontrolled studies. In addition, whilst VNS is

viewed as cost-effective for use in epilepsy, the cost-effectiveness for TRD is unknown. A high

quality randomised controlled trial is needed to inform clinical practice regarding the use of VNS

for TRD and to inform future guidelines.

Recognising that a feasibility study will be required to assess the ability of the sham procedure to

act as a placebo, a step-wise approach is proposed as outlined above. This is a hard stop-go

criterion and applicants will need to take account of this in the design and costings of the study

2.3

Notice Coding and Classification

2.4

Total quantity or scope of tender

3 Conditions for Participation

3.1

Minimum standards and qualification required

4 Administrative Information

4.1

Type of Procedure

The procedure type is unknown.

4.2

Reference number attributed to the notice by the contracting authority

18/194

4.3

Time Limits

   03-04-2019  Time 13:00

4.5

Language or languages in which tenders or requests to participate can be drawn up

EN 

4.6

Tender Submission Postbox

5 Other Information

5.1

Additional Information

Please visit the following portal to view this notice:

https://www.nihr.ac.uk/funding-and-support/funding-opportunities/18194-vagus-nerve-stimulation-for-highly-treatment-resistant-depression/9708

The deadline for applications is 1pm, 3 April 2019.

(MT Ref:281538)

5.2

Additional Documentation

5.3

Publication date of this notice

 17-12-2018

Current Notes