Table 19Evidence summary table for fluoxetine alone/fluoxetine combined with CBT versus CBT alone/placebo/fluoxetine alone

Fluoxetine alone vs. CBT aloneFluoxetine with CBT vs. placeboFluoxetine with CBT vs. fluoxetine aloneFluoxetine with CBT vs. CBT alone
Published onlyPublished onlyPublished onlyPublished only
Total no. of trials (total no. of participants)1 RCT (220)1 RCT (219)1 RCT (216)1 RCT (218)
Depressive symptoms
Clinician completed
CDRS-R
K = 1; N = 220

K = 1; N = 219

K = 1; N = 216

K = 1; N = 218
Clinical Improvement
Clinician completed
CGI-I
K = 1; N = 220

K = 1; N = 219

K = 1; N = 216

K = 1; N = 218
Harms
Harm-related adverse event
K = 1; N = 220

K = 1; N = 219
?
K = 1; N = 216

K = 1; N = 218
Suicide attempts
K = 1; N = 220

K = 1; N = 219

K = 1; N = 216

K = 1; N = 218
Suicide-related events
K = 1; N = 220

K = 1; N = 219

K = 1; N = 216

K = 1; N = 218
Suicide ideation (SIQ)
K = 1; N = 220
×
K = 1; N = 219

K = 1; N = 216
×
K = 1; N = 218
NNTB/NNTH
Clinical improvement (CGI)NNTB = 6 (4 to 25)NNTB = 3 (2 to 5)NNTB = 10 (5 to 50)NNTB = 4 (3 to 7)
Harm-related adverse event11.9% vs. 4.5%: NNTH 14 (7 to 455)8.4% vs. 5.4%: NNTH 33 (NNTH 11 to ∞ to NNTB 28)8.4% vs. 11.9%: NNTB 29 (NNTB 9 to ∞ to NNTH 23)11.9% vs. 4.5%: NNTH 14 (7 to 455)
Suicide attempts1.8% vs. 0.9%: NNTH 108 (NNTH 25 to ∞ to NNTB 47)3.7% vs. 0%: NNTH 27 (NNTH 13 to ∞ to NNTB 455)3.7% vs. 1.8%: NNTH 53 (NNTH 16 to ∞ to NNTB 42)1.8% vs. 0.9%: NNTH 108 (NNTH 25 to ∞ to NNTB 47)
Suicide-related events5.6% vs. 4.5%: NNTH 91 (NNTH 15 to ∞ to NNTB 22)5.6% vs. 3.6%: NNTH 50 (NNTH 14 to ∞ to NNTB 29)5.6% vs. 8.3%: NNTB 38 (NNTB 11 to ∞ to NNTH 25)5.6% vs. 4.5%: NNTH 91 (NNTH 15 to ∞ to NNTB 22)

Note.● = evidence of a clinically important effect favouring treatment A;○ = limited evidence of a clinically important effect favouring treatment A; ⌀ = limited evidence of clinically important effect favouring treatment B; × = there is unlikely to be a clinically important difference between groups; ? = the evidence is inconclusive.

From: 7, Pharmacological and physical treatment of depression in children and young people

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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