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Randomised trial of fluoxetine and cognitive-behavioural therapy (CBT) versus fluoxetine alone in adolescents with persistent major depression (MD).
ISRCTN ISRCTN83809224
DOI 10.1186/ISRCTN83809224
ClinicalTrials.gov identifier
EudraCT number
Public title Randomised trial of fluoxetine and cognitive-behavioural therapy (CBT) versus fluoxetine alone in adolescents with persistent major depression (MD).
Scientific title
Acronym N/A
Serial number at source HTA 97/29/01
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Mental and behavioural disorders: Depression, anxiety, neuroses
Participants - inclusion criteria Adolescents aged 11 through 17 years with mental disorders
Participants - exclusion criteria Not provided at time of registration
Anticipated start date 01/09/2000
Anticipated end date 31/05/2005
Status of trial Completed
Patient information material
Target number of participants 200
Interventions 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.
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).
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.
Sources of funding NIHR Health Technology Assessment Programme - HTA (UK)
Trial website
Publications 1. 2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17556431
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18462573
3. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18230146
4. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22836732
Contact name Prof  Ian  Goodyer
  Address Department of Child and Adolescent Psychiatry
University of Cambridge
Douglas House
18b Trumpington Road
  City/town Cambridge
  Zip/Postcode CB2 2AH
  Country United Kingdom
  Tel +44 (0)122 333 6098/99
  Fax +44 (0)122 374 6122
  Email ig104@cam.ac.uk
Sponsor Department of Health (UK)
  Address Quarry House
Quarry Hill
  City/town Leeds
  Zip/Postcode LS2 7UE
  Country United Kingdom
  Tel +44 (0)1132 545 843
  Email Sheila.Greener@doh.gsi.gov.uk
  Sponsor website: http://www.dh.gov.uk/en/index.htm
Date applied 25/04/2003
Last edited 01/07/2013
Date ISRCTN assigned 25/04/2003
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