A randomised controlled trial to compare the cost-effectiveness of tricyclic antidepressants, selective serotonin re-uptake inhibitors and lofepramine

ISRCTN	ISRCTN14453847
DOI	https://doi.org/10.1186/ISRCTN14453847
Protocol serial number	HTA 96/61/11
Sponsor	Department of Health (UK)
Funder	NIHR Health Technology Assessment Programme - HTA (UK)

Submission date: 25/04/2003
Registration date: 25/04/2003
Last edited: 08/11/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Christopher Thompson
Scientific

Academic Psychiatry
University of Southampton
Royal South Hants Hospital
Brinton's Terrace
Southampton
SO14 0YG
United Kingdom

Phone	+44 (0)23 80 825 533
Email	ct1@soton.ac.uk

Study information

Primary study design	Interventional
Study design	Three-arm randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	A randomised controlled trial to compare the cost-effectiveness of tricyclic antidepressants, selective serotonin re-uptake inhibitors and lofepramine
Study acronym	AHEAD
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Mental and behavioural disorders: Depression, anxiety, neuroses
Intervention	Tricyclic antidepressants, selective serotonin re-uptake inhibitors and lofepramine
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	tricyclic antidepressants, SSRIs and lofepramine
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	31/07/2003

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	327
Key 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.
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/02/1999
Date of final enrolment	31/07/2003

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Academic Psychiatry

Southampton
SO14 0YG
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan	Not provided at time of registration

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	HTA monograph	01/05/2005		Yes	No

Editorial Notes

08/11/2022: Internal review.