Table 33Evidence profile & quality assessment of trials comparing fluoxetine combined with CBT versus placebo for treatment of depression in young people

Study IDQuality assessmentSummary of findings
QualityConsistencyDirectnessOther modifying factorsNo. of patientsEffectClinical interpretation of the effectQuality of evidence (high, moderate, low, very low)
Fluoxetine with CBTPlaceboRR/SMD (95% CI)AUC/NNT (95% CI)
Benefits
 Depressive symptoms (measured with CDRS-R after 12 weeks)
TADS2004No serious limitationsNot applicableSome uncertainty*Sparse data107112SMD -0.98 (-1.26 to -0.70)AUC 76% (69 to 81)Evidence of benefitModerate
 Clinical improvement (measured with CGI-I after 12 weeks)
TADS2004No serious limitationsNot applicableSome uncertainty*Sparse data107112RR 0.44 (0.32 to 0.62)AUC 68% (62 to 74)Evidence of benefitModerate
Harms
 Harm-related adverse event (after 12 weeks)
TADS2004No serious limitationsNot applicableSome uncertainty*Sparse data107112RR 1.57 (0.58 to 4.26)8.4% vs. 5.4%: NNTH 33 (NNTH 11 to ∞ to NNTB 28)Limited evidence of harmModerate
 Suicide attempts (after 12 weeks)
TADS2004No serious limitationsNot applicableSome uncertainty*Sparse data107112RR 9.42 (0.51 to 172.83)3.7% vs. 0%: NNTH 27 (NNTH 13 to ∞ to NNTBLimited evidence of harmModerate
 Suicide-related events (after 12 weeks)
TADS2004No serious limitationsNot applicableSome uncertainty*Sparse data107112RR 1.57 (0.46 to 5.41)5.6% vs. 3.6%: NNTH 50 (NNTH 14 to ∞ to NNTB 29)Limited evidence of harmModerate
 Suicide ideation (measured with the Suicidal Ideation Questionnaire after 12 weeks)
TADS2004No serious limitationsNot applicableSome uncertainty*Sparse data107112SMD -0.05 (-0.31 to 0.21)AUC 51% (44 to 59)Evidence of no differenceModerate

RR = relative risk; SMD = standardised mean difference; NNTH = number needed to treat (Harm); AUC (Area Under the Curve) = The AUC represents the probability that a randomly selected participant in the treatment group has a better result than one in the comparison group. The following values can be used to help judge the magnitude of the effect: 56% = a smaller than typical effect; 64% = typical effect; 71% = larger than typical effect; ≥76% = much larger than typical effect; CDRS = Children's Depression Rating Scale; CGI-I = Clinical Global Impression – Improvement subscale.

*

There was some uncertainty because 56% of the sample was recruited from newspaper, radio or TV advertisements.

Clinical threshold for benefit: RR ≤ 0.20 or AUC ≥ 61%; harm: RR ≥ 5 or NNTH ≤ 50.

From: Appendix P, Evidence profile tables

Cover of Depression in Children and Young People
Depression in Children and Young People: Identification and Management in Primary, Community and Secondary Care.
NICE Clinical Guidelines, No. 28.
National Collaborating Centre for Mental Health (UK).
Leicester (UK): British Psychological Society; 2005.
Copyright © 2005, The British Psychological Society & The Royal College of Psychiatrists.

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