Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
27/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Christopher Thompson

ORCID ID

Contact details

Academic Psychiatry
University of Southampton
Royal South Hants Hospital
Brinton's Terrace
Southampton
SO14 0YG
United Kingdom
+44 (0)23 80 825 533
ct1@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 96/61/11

Study information

Scientific title

Acronym

AHEAD

Study hypothesis

This project will be a three-arm randomised controlled open label controlled study of the cost effectiveness of tricyclic antidepressants, SSRIs and lofepramine in the primary care setting. Outcome will be assessed over a one year period using well established clinical, quality of life, and economic measures at intervals of one or three months. The objectives are 1) to compare the cost effectiveness and cost utility of the initial choice of SSRIs and tricyclic antidepressants in general practice and 2) to compare the cost effectiveness and cost utility of the initial choice of SSRIs and lofepramine in general practice.

Please note that, as of 10 January 2008, the anticipated end date of this trial has been updated from 31 July 2002 to 31 July 2003.

Ethics approval

Not provided at time of registration.

Study design

Three-arm randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Mental and behavioural disorders: Depression, anxiety, neuroses

Intervention

Tricyclic antidepressants, selective serotonin re-uptake inhibitors and lofepramine

Intervention type

Drug

Phase

Not Specified

Drug names

tricyclic antidepressants, SSRIs and lofepramine

Primary outcome measures

Quality of life and economic measures.
Clinical outcomes are being assessed through use of the Clinical Interview Schedule, Rviesed version; the Hospital Anxiety and Depression Scale; the Euroqol; and the SF-36 Quality of Life Scale. Use of health services is being assessed through patient-completed questionnaires, and through detailed examination of general practice medical records.

Secondary outcome measures

Not provided at time of registration.

Overall trial start date

01/02/1999

Overall trial end date

31/07/2003

Reason abandoned

Eligibility

Participant inclusion criteria

The sample group is of 327 patients who are prescribed antidepressant drugs by their general practitioner. The sociodemographic characteristics and other features of this group will be analysed, to evaluate whether the sample is representative of the wider population of general practice patients received antidepressant treatment.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

327

Participant exclusion criteria

Not provided at time of registration.

Recruitment start date

01/02/1999

Recruitment end date

31/07/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Academic Psychiatry
Southampton
SO14 0YG
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15876362

Publication citations

  1. HTA monograph

    Peveler R, Kendrick T, Buxton M, Longworth L, Baldwin D, Moore M, Chatwin J, Goddard J, Thornett A, Smith H, Campbell M, Thompson C, A randomised controlled trial to compare the cost-effectiveness of tricyclic antidepressants, selective serotonin reuptake inhibitors and lofepramine., Health Technol Assess, 2005, 9, 16, 1-134, iii.

Additional files

Editorial Notes