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. 2023 Oct 9;2023(10):CD011769. doi: 10.1002/14651858.CD011769.pub2

King 2009.

Study characteristics
Methods Parallel trial of citalopram versus placebo
Participants Inclusion criteria:
  • meet the DSM‐4‐TR criteria for ASD, Asperger's disorder, or PDD

  • have an illness severity rating of at least moderate on the CGI‐S

  • score at least moderate on compulsive behaviours


Exclusion criteria: details not provided
Location/setting: s6 academic medical centres in the USA
Sample size: 149 (73 children were randomised to citalopram and 76 to placebo)
Number of withdrawals/dropouts: placebo: 13 withdrew (7 AEs, 1 protocol violation, 5 withdrew consent) Citalopram hydrobromide: 13 withdrew (1 serious AE, 8 AEs, 2 protocol violations, 2 withdrew consent)
Mean age: 9.4 years
Gender: 128/149 boys
IQ: 43% had nonverbal IQ > 70
Baseline ABC‐I or other BoC: citalopram ABC‐I 13.2; placebo 11.2; self‐injurious behaviour 2.8 (citalopram); 2.6 (placebo)
Concomitant medications: psychotropic medication not allowed during the study. Only sleep medications allowed
History of previous medications: details not provided
Interventions Intervention (citalopram hydrobromide) for 12 weeks: 10 mg/5 mL. Mean maximum dose was 16.5 mg/day (± 6.5 mg)
Comparator (placebo) for 12 weeks: equivalent placebo
Outcomes Primary outcomes:
  • Irritability, measured using the ABC‐Irritability subscale (Aman 1985)

  • self‐injurious behaviour, measured using the Repetitive Behavior Scale‐Self‐Injurious subscale (Bodfish 2000)


Secondary outcomes: none reported
Timing of outcome assessments: AEs assessed at bi‐weekly visits; ABC‐I and self‐injury measured at baseline and endpoint
Notes Study start date: April 2004
Study end date: October 2006
Source of funding: all authors received salary contributions from the National Institutes of Health, which supported this study.
Conflicts of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were randomly assigned to citalopram or placebo using permuted blocks with randomly varying block sizes stratified by site and by age (5‐11 vs 12‐17 years)
Allocation concealment (selection bias) Unclear risk Details not provided
Blinding of participants and personnel (performance bias)
All outcomes Low risk Two masked clinicians met with participants during each scheduled evaluation
Blinding of outcome assessment (detection bias)
All outcomes Low risk The evaluating clinician monitored efficacy and was blinded to AEs
Incomplete outcome data (attrition bias)
All outcomes Unclear risk LTFU citalopram: 13 withdrew, 1 due to serious AE; 8 AEs; 2 protocol violations; 2 consent withdrawn
LTFU placebo: 13 withdrawn, 7 AEs; 1 protocol violation; 5 consent withdrawn
Selective reporting (reporting bias) Low risk The trial protocol was recorded on Clinicaltrials.gov and outcomes were reported in the paper.
Other bias High risk Study authors all work with/for pharmaceutical companies