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
Secondary identifying numbers HTA 96/61/11
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

Study designThree-arm randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific titleA randomised controlled trial to compare the cost-effectiveness of tricyclic antidepressants, selective serotonin re-uptake inhibitors and lofepramine
Study acronymAHEAD
Study objectivesThis 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) studiedMental and behavioural disorders: Depression, anxiety, neuroses
InterventionTricyclic antidepressants, selective serotonin re-uptake inhibitors and lofepramine
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)tricyclic antidepressants, SSRIs and lofepramine
Primary outcome measureQuality 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 measuresNot provided at time of registration.
Overall study start date01/02/1999
Completion date31/07/2003

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexBoth
Target number of participants327
Key inclusion criteriaThe 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 criteriaNot provided at time of registration.
Date of first enrolment01/02/1999
Date of final enrolment31/07/2003

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Academic Psychiatry
Southampton
SO14 0YG
United Kingdom

Sponsor information

Department of Health (UK)
Government

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom

Phone +44 (0)1132 545 843
Email Sheila.Greener@doh.gsi.gov.uk
Website http://www.dh.gov.uk/en/index.htm
ROR logo "ROR" https://ror.org/03sbpja79

Funders

Funder type

Government

NIHR Health Technology Assessment Programme - HTA (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot 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.