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

Gordon 1993.

Study characteristics
Methods Cross‐over trial of clomipramine, desipramine, and placebo
Participants Inclusion criteria:
  • meet the DSM‐III‐R and ADI criteria for ASD

  • free of significant medical problems, including seizures

  • free of psychotropic medications for at least 3 months prior to the study


Exclusion criteria:
  • significant medical problems, including seizures, by history, physical examination, and laboratory examination

  • used psychoactive medications during the 3 months prior to the study.


Location/setting: outpatient clinic, USA
Sample size: 24 in total (cross‐over)
Number of withdrawals/dropouts: 1 in clomipramine group and 1 other dropout although group was not specified.
Gender: 15/24 male
Age range: 6‐18 years
IQ range: 30‐107
Baseline ABC‐I or other BoC: not reported
Concomitant medications: not reported
History of previous medications: not reported
Interventions Intervention 1 (clomipramine) for 5 weeks: mean final dose was 152 mg/day (SD 56), 4.3 mg/kg/day (SD 0.8). The initial dosage was 25 mg/day, and titrated to a maximum of 5 mg/kg per day or 250 mg/day usually between weeks 2 and 3
Intervention 2 (desipramine) for 5 weeks: mean final dose was 127 mg/day (SD 52). 4.0 mg/kg/day (SD 1.2). The initial dosage was 25 mg/day, titrated to a maximum of 5 mg/kg per day or 250 mg/day usually between weeks 2 and 3
Comparator (placebo) for 5 weeks: equivalent placebo
Outcomes Primary outcomes: AEs
Secondary outcomes: none reported
Timing of outcome assessment: week 5 (endpoint)
Notes Study start date: not reported
Study end date: not reported
Source of funding: not reported
Conflicts of interest: none declared
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "randomisation was performed by the National Institutes of Health pharmacy using a random‐number table".
Allocation concealment (selection bias) Unclear risk Details not provided
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Details of blinding were not provided.
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Details not provided
Incomplete outcome data (attrition bias)
All outcomes High risk LTFU: clomipramine/desipramine 2; 1 in the clomipramine/ desipramine group because of violent outbursts and 1 because the group home administered his medicine to the wrong participant.
Selective reporting (reporting bias) Unclear risk Outcomes that were mentioned in the paper were reported. No protocol was available.
Other bias Unclear risk No baseline comparisons were reported by group.