| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN63222059 |
| Date ISRCTN assigned | 14/07/2004 |
| Local reference number(s) | G0300677 |
| Public title | A Trial Platform of Enhanced care for Depression in Primary Care |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Mental and Behavioural Disorders |
| Study hypothesis | 1. To design and refine a standardised ECD intervention protocol appropriate to the UK primary health care setting and acceptable to clinicians, practitioners and patients
2. To estimate contamination, clustering and effect size of the intervention within a pilot Phase II trial
3. To estimate trial recruitment rates through monitoring recruitment rates within the pilot Phase II trial
4. To examine the issue of treatment integrity and acceptability by monitoring the implementation of the ECD intervention protocol within a pilot Phase II trial and conducting qualitative stakeholder interviews |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | Depression presenting in Primary Care |
| Participants - exclusion criteria | Depression not as primary diagnosis; suicidal intent |
| Patient information material |
|
| Anticipated start date | 01/07/2004 |
| Anticipated end date | 30/03/2006 |
| Status of trial | Completed |
| Target number of participants | 144 |
| Interventions | 1. Enhanced care for depression
2. Usual care |
| Primary outcome measure(s) | Clinical response (change from baseline Hamilton depression HAM-D score), 50% reduction in depressive symptoms |
| Secondary outcome measure(s) | 1. Quality of life (SF-12 & EQ-5D)
2. Health care utilisation (including GP visits, medication use, secondary care referrals)
3. Prescribing and adherence to medication measured against NICE guidelines (from individual patient records, filled prescriptions and patient self report) |
| Publications | Results: http://www.ncbi.nlm.nih.gov/pubmed/16814628 |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | University of York (UK) |
| Sponsor details | Prof Trevor Sheldon
Department of Health Sciences
Seebohhm Rowntree Building
University of York
University Road
Heslington
York
United Kingdom
YO10 5DD |
| Sponsor website | http://www.york.ac.uk/ |
| Contact name | Prof David Richards |
| Contact details | Dept Health Sciences
Seebohm Rowntree Building
University of York
University Road
Heslington
York
United Kingdom
YO10 5DD |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN63222059 |
| Date last extracted from ISRCTN register | 17/04/2008 |
