Table 29Evidence profile & quality assessment of trials comparing mirtazapine with placebo for treatment of depression in children and young people

No. of studiesQuality assessmentSummary of findings
QualityConsistencyDirectnessOther modifying factorsNo. of patientsEffectClinical interpretation of the effectQuality of evidence (high, moderate, low, very low)
VenlafaxinePlaceboRR/SMD (95% CI)AUC/NNT (95% CI)
Benefits
 Depressive symptoms (measured with CDRS-R after 8 weeks)
MIRTAZAPINE
STUDY1
MIRTAZAPINE
STUDY2
No serious limitationsImprecise data16485SMD −0.20 (-0.46 to 0.06)AUC 56% (48 to 63)InconclusiveModerate
Harms
 Suicidal behaviour/ideation (after 8 weeks)*
MIRTAZAPINE
STUDY1
MIRTAZAPINE
STUDY2
No serious limitationsSome uncertaintyImprecise data17089RR 1.58 (0.06 to 38.37)0.6% vs. 0%: NNTH 170 (NNTH 38 to ∞ to NNTB 68)InconclusiveLow
 Early discontinuation because of adverse events (after 8 weeks)
MIRTAZAPINE
STUDY1
MIRTAZAPINE
STUDY2
No serious limitationsImprecise data17088RR 1.55 (0.43 to 5.59)5.3% vs. 3.4%: NNTH 53 (NNTH 15 to ∞ to NNTB 32)Limited evidence of harmModerate

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.

*

Data extracted from FDA re-analysis (Hammad, 2004).

There was uncertainty about the outcome measure because the trials were not designed to detect suicidality and therefore may underestimate the risk.

Clinical threshold for benefit: RR ≤ 0.50 or AUC ≥ 56%; harm: RR ≥ 2 or NNTH ≤ 100.

Data extracted from FDA re-analysis (Hammad, 2004).

There was uncertainty about the outcome measure because the trials were not designed to detect suicidality and therefore may underestimate the risk.

Clinical threshold for benefit: RR ≤ 0.50 or AUC ≥ 56%; harm: RR ≥ 2 or NNTH ≤ 100.

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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