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
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 |
|---|---|
| ct1@soton.ac.uk |
Study information
| Study design | Three-arm randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/02/1999 |
| Completion date | 31/07/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Academic Psychiatry
Southampton
SO14 0YG
United Kingdom
SO14 0YG
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
| Phone | +44 (0)1132 545 843 |
|---|---|
| Sheila.Greener@doh.gsi.gov.uk | |
| Website | http://www.dh.gov.uk/en/index.htm |
"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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
