Randomised trial of fluoxetine and cognitive-behavioural therapy (CBT) versus fluoxetine alone in adolescents with persistent major depression (MD).

Completed

• Conditions: Mental and behavioural disorders: Depression, anxiety, neuroses; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN83809224
• Lead Sponsor: Department of Health (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2003-04-25
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

Adolescents aged 11 through 17 years with mental disorders

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.