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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
HTA monograph in http://www.ncbi.nlm.nih.gov/pubmed/15876362
Publication citations
-
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.