TABLE 1

Characteristics of Included Studies

StudyYearMedicationSample SizeDesignLength of TreatmentMean AgeGender (% Male)JADAD ScoreMean Dose (mg/d)
Gordon et al461993Clomipramine (TCA)12Crossover5 wk10.4 y573152
McDougle et al471996Fluvoxamine (SSRI)30Parallel12 wk30.1 y904277
Remington et al482001Clomipramine (TCA)36Crossover7 wk16.4 y833128
Hollander et al492005Fluoxetine (SSRI)39Crossover8 wk8.2 y77310.6
King et al502009Citalopram (SSRI)149Parallel12 wk9.4 y86516.5
Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders,a NCT0060953135Active, not recruitingCitalopram (SSRI)13Parallel12 wk22 yInformation not provided318.3
McDougle et al,b unpublished52CompletedFluvoxamine (SSRI)34Parallel12 wk5–1885UK106.9
Study of Fluoxetine in Autism (SOFIA),b NCT0051532043Completed 1/09Fluoxetine (SSRI)158Parallel14 wk5–17 yUKUKUK
Study of Fluoxetine in Adults With Autistic Disorder,b NCT0002740444Completed 10/05Fluoxetine (SSRI)48Parallel12 wk18–65 yUKUKUK
Fluvoxamine and Sertraline in Childhood Autism – Does SSRI Therapy Improve Behaviour and/or Mood?b NCT0065517445Completed 1/07Fluvoxamine (SSRI)108ParallelChildren were started on 12.5 mg. If no therapeutic effectiveness was observed after 8 wks, then the child’s dosage could be increased for an additional 8 wk3–10 yUKUK12.5
Effectiveness of Early Intervention With Fluoxetine in Enhancing Developmental Processes in Children With Autism,b NCT0018333946Completed 2/08Fluoxetine (SSRI)19Parallel12 mo30–58 moUKUK2–20
  • SSRI, selective serotonin reuptake inhibitor; TCA, tricyclic antidepressant; UK, unknown.

  • a We received trial data in response to our request for relevant data for this trial only.

  • b Studies completed but unpublished. Requests were sent to the principal investigators for data associated with each of these trials.