Randomised trial of fluoxetine and cognitive-behavioural therapy (CBT) versus fluoxetine alone in adolescents with persistent major depression (MD).
| ISRCTN | ISRCTN83809224 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83809224 |
| Protocol serial number | HTA 97/29/01 |
| 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
- 01/07/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Child and Adolescent Psychiatry
University of Cambridge
Douglas House
18b Trumpington Road
Cambridge
CB2 2AH
United Kingdom
| Phone | +44 (0)122 333 6098/99 |
|---|---|
| ig104@cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | The main objective is to test the principal hypothesis that the additional costs of Cognitive Behavioural Therapy (CBT) will be offset by improvements in patient outcomes and quality of life, and/or savings in the use of other health services, compared with fluoxetine alone. Other objectives are to determine whether the treatments differ (a) at follow-up, (b) in respect of other outcomes such as comorbid mental health problems and child/parent satisfaction, (c) within subgroups defined by severity. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Mental and behavioural disorders: Depression, anxiety, neuroses |
| Intervention | Please note that, as of 17 January 2008, the end date of this trial was updated from 31 October 2003 to 31 May 2005. Interventions: Because 1/4 cases of early onset depression remit rapidly, all cases will complete a brief initial educational/supportive intervention, and only those who still have major depression (MD) after 2 weeks will be randomised to CBT and fluoxetine or fluoxetine (stratified by severity). The design and execution of the trial, including telephone randomisation, will be supervised by the Health Care Trials Unit in Manchester (MCR) and the results will be reported in line with the CONSORT guidance. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Fluoxetine |
| Primary outcome measure(s) |
Cost and outcome measurement: Costs of the treatments to NHS and non-NHS services will be assessed with measures developed collaboratively by the Department of Health Economics in York and by Harrington's team in MCR in two clinical trials, one of which involved adolescents who had deliberately poisoned themselves (of whom >60% had MD). Clinical effectiveness and consumer views will be assessed using a range of standardised measures at 6 weeks, at 12 weeks, and at 6 months follow-up. The primary outcome will be a clinical measure of global functioning, the Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA). |
| Key secondary outcome measure(s) |
Other measures will include remission from depression, comorbid problems and adverse effects. Vigorous efforts will be made to ensure that outcomes are assessed without knowledge of treatment group. |
| Completion date | 31/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 200 |
| Key inclusion criteria | Adolescents aged 11 through 17 years with mental disorders |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2000 |
| Date of final enrolment | 31/05/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CB2 2AH
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 21/07/2007 | Yes | No | |
| Results article | results | 29/01/2008 | Yes | No | |
| Results article | results | 01/05/2008 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No |
