Condition category
Mental and Behavioural Disorders
Date applied
25/04/2003
Date assigned
25/04/2003
Last edited
01/07/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Ian Goodyer

ORCID ID

Contact details

Department of Child and Adolescent Psychiatry
University of Cambridge
Douglas House
18b Trumpington Road
Cambridge
CB2 2AH
United Kingdom
+44 (0)122 333 6098/99
ig104@cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 97/29/01

Study information

Scientific title

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Fluoxetine

Primary outcome measures

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 measures

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.

Overall trial start date

01/09/2000

Overall trial end date

31/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Adolescents aged 11 through 17 years with mental disorders

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

200

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2000

Recruitment end date

31/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Child and Adolescent Psychiatry
Cambridge
CB2 2AH
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Quarry House
Quarry Hill
Leeds
LS2 7UE
United Kingdom
+44 (0)1132 545 843
Sheila.Greener@doh.gsi.gov.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/en/index.htm

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

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

Publication citations

  1. Results

    Goodyer I, Dubicka B, Wilkinson P, Kelvin R, Roberts C, Byford S, Breen S, Ford C, Barrett B, Leech A, Rothwell J, White L, Harrington R, Selective serotonin reuptake inhibitors (SSRIs) and routine specialist care with and without cognitive behaviour therapy in adolescents with major depression: randomised controlled trial., BMJ, 2007, 335, 7611, 142, doi: 10.1136/bmj.39224.494340.55.

  2. Results

    Wilkinson PO, Goodyer IM, The effects of cognitive-behavioural therapy on mood-related ruminative response style in depressed adolescents., Child Adolesc Psychiatry Ment Health, 2008, 2, 1, 3, doi: 10.1186/1753-2000-2-3.

  3. Results

    Wilkinson PO, Harris C, Kelvin R, Dubicka B, Goodyer IM, Associations between adolescent depression and parental mental health, before and after treatment of adolescent depression., Eur Child Adolesc Psychiatry, 2013, 22, 1, 3-11, doi: 10.1007/s00787-012-0310-9.

  4. Goodyer IM, Dubicka B, Wilkinson P, Kelvin R, Roberts C, Byford S, Breen S, Ford C, Barrett B, Leech A, Rothwell J, White L, Harrington R, A randomised controlled trial of cognitive behaviour therapy in adolescents with major depression treated by selective serotonin reuptake inhibitors. The ADAPT trial., Health Technol Assess, 2008, 12, 14, iii-iv, ix-60.

Additional files

Editorial Notes