Table 2.
Summary of citalopram 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) |
2006; von Knorring; J Clin Psychopharm |
n = 244 (% males not specified) | 16 (1) (range: 13–18) | Cit 10–40 mg vs Pl (mean dose Cit 26 mg/day) | 12 weeks |
Kiddie-SADS-P MADRS BDI GAF |
Kiddie-SADS-P: decrease from baseline for both groups (no sig difference); responders for Cit = 60% vs Pl = 61% MADRS: no significant difference BDI: no significant difference GAF: no significant difference |
Suicide-related events: Cit=14 pts vs Pl=5 pts (p=0.06) AE (%above Pl): Fatigue (5), Nausea (4), Insomnia (2), Headache (1) Discontinuation due to AE: Pl=8% vs Cit=11% |
| Prospective Double-Blind Randomized Trial (Level 1b) |
2004; Wagner; Am J Psychiatry |
n = 178 (47% male) | 12.1 (3.1) (range: 7–17) | Cit 20–40 mg vs Pl (mean dose Cit 24 mg/day) | 8 weeks |
CDRS-R CGI-I CGI-S |
CDRS-R: effect size of 2.9; Cit improvement F=6.58, df=1, 150 (p<0.05); response rate Cit 36% Pl 24% (p<0.05) CGI-I: rating ≤2 Cit 47% vs Pl 45% CGI-S: Improvement from basline Cit −1.3 vs Pl −1.0 |
AE (%above Pl): Nausea (10), Rhinitis (7.6), Influenza-like symptoms (6.7), fatigue (4.4), diarrhea (4.4), abdominal pain (4.1), back pain (2.1) Discontinuation due to AE: Pl=5.9% vs Cit=5.6% |
| Prospective Open-Label Trial (Level 2b) |
2010; Schirman; J Neural Transm |
n = 78 (50% male) | 13.9 (2.8) (range: 7–18) | Cit 20–40mg/day (mean dose of Cit 30.2 ±10.1mg/day) | 8 weeks |
CGI-I CDRS-R CDI BDI SCARED |
CGI-I: significant improvement in 55.8% of all pts (85.1% in pts w/moderate illness, 47.3% in pts with marked illness, 27.2% in pts w/ severe illness) CDRS-R: 43.1% showed ≥50% reduction in symptoms (p<0.001) CDI: significant reduction in depression severity (p=0.005) BDI: significant reduction in depression severity (p<0.001) SCARED: 50.% pts decreased score by ≥50% (p<0.001) |
CDRS-R Item 13 (suicidality) = 44.8% decrease in suicidal ideation (p<0.001) SIQ = 21.6% decrease (p=0.054) AE reported: fatigue (31.6%), motor agitation (25.3%), decreased appetite (21.1%), headache (20%), gastric discomfort (16.8%), insomnia (15.8%), psychological agitation (14.7), hypersomnia (10.5%), sweating (10.5%) psychological & motor agitation more common in males (p<0.05) Discontinuation due to AE in 10 pts (10.8%) |
| Prospective Open-Label Trial (Level 2b) |
2005; Shirazi; J Child Adolesc Psychopharmacol |
n = 30 (47% male) | 13.57 (2.5) (range: 8–17) | Cit 10–40 mg/day (mean dose Cit 20.8mg/day) | 6 weeks |
HDRS CGAS |
HDRS: X=22.78; t=−14.12 (P<0.000) CGAS: X=26.02; t = 9.68 (P<0.000) Moderate to large effect (≥50% change in HDRS & CGAS) in 91.7% of pts |
AE reported by 3 pts (10%) delayed menstrual period, diuresis, nausea, diaphoresis Discontinuation due to AE in 6 patients (1=nausea & vomiting; 5=switched to mania) |
| Retrospective Chart Review (Level 2b) |
2002; Baumgartner; Ann Pharmacother |
n = 17 (52.9% male) | 13.2 (2.5) (range: 8–17) | Cit 10–40 mg/day (mean dose Cit 22.4 ± 7.3 mg/day) | 12 weeks |
CGI-I CDRS-R IDS-C SCARED |
CGI−I: 3/17 reported as “very much improved & 9/17 as much improved” CDRS-R: 75% of pts had reduction of ≥50 % from baseline; 38% of pts had reduction of >70% IDS-C: 38% of pts had reduction of >50% from baseline SCARED: 50–75% of pts had >50% reduction from baseline |
AE reported: drowsiness (29%), headache (24%), shakiness (18%), nausea (12%), dizziness (6%), decreased libido (6%), decreased appetite (6%) Discontinuation due to AE in 1 pt (6%) |
| Retrospective Chart Review (Level 2b) |
2001; Bostic; J Child Adolesc Psychopharmacol |
n = 21 (57% male) | 15 (1.8) (range: 12–17) | Cit 10–60 mg/day (mean dose of Cit 26.5 ± 13.1 mg/day) | 128.5 ± 84 days |
CGI-I CGI-S |
CGI-I: 76% much or very much improved CGI-S: reduction in severity 4.1±1.04 to 2.9 ±0.94 (p<0.0026) |
Mild AE reported by 33% of pts including headache, dizziness, nausea, sedation, agitation, & sweating Discontinuation due to AE in 3 pts (14%) |
Abbreviations: AE = adverse events; Cit = citalopram; Pl = placebo
Abbreviations of Rating Scales used
BDI = Beck Depression Inventory
CDI = Children’s Depression Inventory
CDRS-R = Children’s Depression Rating Scale - Revised
CGAS = Children Global Assessment Scale
CGI-I = Clinical Global Impression - Improvement
CGI-S = Clinical Global Impression - Severity
GAF = Global Assessment of Functioning
HDRS = Hamilton Depression Rating Scale
IDS-C = Inventory of Depressive Symptomatology - Clinician Rated
Kiddie-SADS-P = Schedule for Affective Disorders and Schizophrenia for school-aged children - Present episode version
MADRS = Montgomery Asberg Depression Rating Scale
SCARED = Screen for Child Anxiety Related Emotional Disorders
SIQ = Suicide Ideation Questionnaire