Selective serotonin reuptake inhibitors (SSRIs) and routine specialist care with and without cognitive behaviour therapy in adolescents with major depression: randomised controlled trialBMJ 2007; 335 doi: https://doi.org/10.1136/bmj.39224.494340.55 (Published 19 July 2007) Cite this as: BMJ 2007;335:142
- Ian Goodyer, professor of child and adolescent psychiatry1,
- Bernadka Dubicka, consultant in adolescent psychiatry and honorary lecturer2,
- Paul Wilkinson, clinical lecturer in child and adolescent psychiatry1,
- Raphael Kelvin, consultant child and adolescent psychiatrist and associate lecturer3,
- Chris Roberts, senior lecturer in medical statistics4,
- Sarah Byford, senior lecturer in health economics5,
- Siobhan Breen, trainee6,
- Claire Ford, health psychologist7,
- Barbara Barrett, research worker5,
- Alison Leech, consultant child and adolescent psychiatrist8,
- Justine Rothwell, research associate9,
- Lydia White, trial manager10,
- Richard Harrington, former professor of child psychiatry11
- 1Developmental Psychiatry Section, Department of Psychiatry, Cambridge University, Cambridge CB2 2AH
- 2Junction Adolescent Unit, Scotforth, Lancaster, and Department of Psychiatry, University of Manchester
- 3Brookside Family Consultation Centre, Cambridge, and Department of Psychiatry, University of Cambridge
- 4Biostatistics Group, Division of Epidemiology and Health Sciences, Manchester University, Manchester
- 5Centre for the Economics of Mental Health, Institute of Psychiatry, London
- 6Clinical Psychology Unit, Department of Psychology, Sheffield University, Sheffield
- 7Cambridgeshire Primary Care Trust, Fulbourn, Cambridge
- 8Thorn Road Clinic, Halton, Cheshire
- 9Division of Psychiatry, University of Manchester, Manchester
- 10Academic Department of Child and Adolescent Psychiatry, University of Manchester, Booth Hall Children's Hospital, Blackley, Manchester
- 11Department of Child and Adolescent Psychiatry, Manchester University, Royal Manchester Children's Hospital, Pendlebury, Manchester
- Correspondence to: I Goodyer
- Accepted 1 May 2007
Objective To determine whether a combination of a selective serotonin reuptake inhibitor (SSRIs) and cognitive behaviour therapy (CBT) together with clinical care is more effective in the short term than an SSRI and clinical care alone in adolescents with moderate to severe major depression.
Design Pragmatic randomised controlled superiority trial.
Setting 6 outpatient clinics in Manchester and Cambridge.
Participants 208 adolescents, aged 11-17, with moderate to severe major or probable major depression who had not responded to a brief initial intervention. Adolescents with suicidality, depressive psychosis, or conduct disorder were included.
Interventions 103 adolescents received an SSRI and routine care; 105 received an SSRI, routine care, and CBT. The trial lasted 12 weeks, followed by a 16 week maintenance phase.
Main outcome measures Change in score on the Health of the Nation outcome scales for children and adolescents (primary outcome) from baseline with 12 weeks as the primary and 28 weeks as the follow-up end point. Secondary measures were change in scores on the mood and feelings questionnaire, the revised children's depression rating scale, the children's global assessment scale, and the clinical global impression improvement scale.
Results At 12 weeks the treatment effect for the primary outcome was −0.64 (95% confidence interval −2.54 to 1.26, P=0.50). In a longitudinal analysis, there was no difference in effectiveness of treatment for the primary (average treatment effect 0.001, −1.52 to 1.52, P=0.99) or secondary outcome measures. On average there was a decrease in suicidal thoughts and self harm. There was no evidence of a protective effect of cognitive behaviour therapy on suicidal thinking or action. By 28 weeks, 57% were much or very much improved with 20% remaining unimproved.
Conclusions For adolescents with moderate to severe major depression there is no evidence that the combination of CBT plus an SSRI in the presence of routine clinical care contributes to an improved outcome by 28 weeks compared with the provision of routine clinical care plus an SSRI alone.
Trial registration Current Controlled Trials ISRCNT 83809224.
Contributors: IG was chief investigator, guarantor, and grant holder responsible for final report and scientific papers. SBr was responsible for assessments over the trial period and final approval. BB was responsible for cost sensitivity analysis, drafting, revising, and final approval. SBy was responsible for health economics strategy, data analysis, drafting, revision, and final approval. BD and PW were responsible for ascertainment of patients, treatment, drafting, revision, and final approval. CF was responsible for assessments over the trial period, revising, and final approval. RK was responsible for drafting, revision, and final approval. AL was responsible for ascertainment of patients, treatment, and final approval. CR was responsible for trial methodology, sample size and data analysis, drafting, revision, and final approval. JR was responsible for assessments over the trial period and final approval. LW was responsible for revising and final approval. RH was chief investigator and grant holder responsible for original protocol.
Funding: NHS Health Technology Assessment (HTA) Programme, Central Manchester and Manchester Children's University Hospitals NHS Trust, and the Cambridge and Peterborough Mental Health Trust. The views and opinions expressed therein are those of the authors and do not necessarily reflect those of the Department of Health.
Competing interests: BD has been reimbursed for attending educational meetings sponsored by Lilly.
Ethical approval: Multi-centre research ethics committee and all relevant local research ethics committees.
- Accepted 1 May 2007