Table 1.
Summary of escitalopram evidence in children and adolescents
| Report Type & Level of Evidence | Year/Lead Author/Journal | # of pts (n), % males | Pt age (mean (SD) and range) (years) | Dosage | Duration of treatment | Efficacy Rating Scales (Bold = 1° Endpoint) | Efficacy Results | Adverse Events (AE) |
|---|---|---|---|---|---|---|---|---|
| Prospective Double-Blind Randomized Trial (Level 1b) |
2009; Emslie; J Am Acad Child Adolesc Psychiatry |
n= 312 (41% male) | Esc group 14.5 (1.5) Pl group 14.7 (1.6) (range: 12–17) |
Esc 10–20 mg vs Pl (mean dose Esc 13.2± 2.9 mg/day) | 1 week placebo lead followed by 8 weeks randomization |
CDRS-R CGI-I CGI-S CGAS |
CDRS-R: mean improvement of −3.356 (P=0.022) CGI-I: mean improvement of −0.344 (P=0.008) Responders (CGI-I ≤2): Esc: 64.3% vs Pl 52.9% CGI-S:mean improvement of −0.37 (P=0.007) CGAS: no mean change |
MC-SSRS=no difference in suicidal behaviour (Pl=2.3% vs Esc=1.5%) or suicidal ideation (Pl=9.4% vs Esc=9.2%) SIQ-JR=no statistical difference (mean change from baseline Pl=−4.6 ±12.0 vs Esc=−2.9±10.2 (P=0.29)) 12 events considered to be self-harm (Pl=6 Esc=6) |
| AE (% above Pl): insomnia (3.9), influenza-like symptoms (3.9), nausea/abdominal pain/diarrhea (2), vomiting (0.8) Decreased platelet count in Esc group (Pl=−2.2x109/L vs Esc=−7.6x109/L) |
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| Discontinuation due to AE: Pl=0.6% vs Esc=2.6% (P=0.21) | ||||||||
| Prospective Double-Blind Randomized Trial (Level 1b) |
2008; Findling; AACAP poster presentation (Extension trial of Emslie 2009) |
n = 77 (41% male) | 14.5 (1.5) (range: 12–17) | Esc 10–20 mg vs Pl | 16 week extension of previous 8 week trial (Emslie 2009) |
CDRS-R CGI-I CGI-S CGAS |
CDRS-R: mean improvement of −4.9 (P=0.005) CGI-I:mean score of Pl=2.5±0.1 vs Esc=2.2 ±0.1 (P<0.05) CGI-S: mean improvement of −0.5 (P<0.05) CGAS: mean improvement of 3.6 (P<0.05) |
MC-SSRS=increase in suicidal behaviour/ideation (Pl=10.9% vs Esc=14.5%) SIQ-JR= mean change from baseline Pl = −5.8±12.8 vs Esc= −3.0±11.7 Suicidality: 2 episodes in each Pl and Esc group (in extension group) |
| AE (above Pl): nausea and insomnia | ||||||||
| Discontinuation due to AE: Pl=0.8% vs Esc=5.2% | ||||||||
| Prospective Double-Blind Randomized Trial (Level 1b) |
2006; Wagner; J Am Acad Child Adolesc Psychiatry |
n = 268 (48% male) | 12.3 (3.0) (range: 6–17) | Esc 10–20 mg vs Pl (mean dose Esc 11.9± 2.3 mg/day) | 8 weeks |
CDRS-R CGI-I CGI-S CGAS |
CDRS-R: not statistically significant (P=0.31) (post hoc analysis of 12–17 year-olds P=0.047) CGI-I: not statistically significant Responders (CGI-I <2): Esc: 62.8% vs Pl 52.3% CGI-S: not statistically significant (P=0.057) CGAS: not statistically significant (P=0.065) |
Suicidality: 1 self-harm episode in Esc group; 2 self-harm episodes in Pl group AE (% above Pl): abdominal pain (5.4), nausea (3.1), vomiting (1.5), headache (1.1), rhinitis (0.1) Discontinuation due to AE: Pl 1.5% vs Esc 1.5% |
Abbreviations
AACAP = American Academy of Child and Adolescent Psychiatry; AE = adverse events; Esc = Escitalopram; Pl = placebo
Abbreviations of Rating Scales used
CDRS-R = Children’s Depression Rating Scale - Revised
CGAS= Children’s Global Assessment Scale
CGI-I= Clinical Global Impressions - Improvement
CGI-S= Clinical Global Impressions -Severity
MC-SSRS= Modified Columbia Suicide Severity Rating Scale
SIQ-JR= Suidical Ideation Questionnaire - Junior High School Version