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ISRCTN
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ISRCTN83809224
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ClinicalTrials.gov identifier
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Public title
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Randomised trial of fluoxetine and cognitive-behavioural therapy (CBT) versus fluoxetine alone in adolescents with persistent major depression (MD).
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Scientific title
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Acronym
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N/A
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Serial number at source
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HTA 97/29/01
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Study hypothesis
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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.
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Mental and behavioural disorders: Depression, anxiety, neuroses
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Participants - inclusion criteria
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Adolescents aged 11 through 17 years with mental disorders
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/09/2000
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Anticipated end date
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31/05/2005
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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200
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Interventions
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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.
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Primary outcome measure(s)
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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).
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Secondary outcome measure(s)
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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.
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Sources of funding
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NIHR Health Technology Assessment Programme - HTA (UK)
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Trial website
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Publications
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2007 results: http://www.ncbi.nlm.nih.gov/pubmed/17556431
2008 results: http://www.ncbi.nlm.nih.gov/pubmed/18462573
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Contact name
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Prof
Ian
Goodyer
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Address
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Department of Child and Adolescent Psychiatry
University of Cambridge
Douglas House
18b Trumpington Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2AH
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Country
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United Kingdom
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Tel
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+44 (0)122 333 6098/99
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Fax
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+44 (0)122 374 6122
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Email
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ig104@cus.cam.ac.uk
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Sponsor
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Department of Health (UK)
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Address
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Quarry House
Quarry Hill
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City/town
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Leeds
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Zip/Postcode
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LS2 7UE
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Country
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United Kingdom
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Email
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Sheila.Greener@doh.gsi.gov.uk
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Sponsor website:
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http://www.dh.gov.uk/en/index.htm
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Date applied
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25/04/2003
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Last edited
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25/08/2009
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Date ISRCTN assigned
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25/04/2003
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