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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83809224

Enrollment

200

Registered

2003-04-25

Start date

2000-09-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental and behavioural disorders: Depression, anxiety, neuroses Mental and Behavioural Disorders Depression

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 cas

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Adolescents aged 11 through 17 years with mental disorders

Exclusion criteria

Exclusion criteria: Not provided at time of registration

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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

Measure	Time frame
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.	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026