Niederhofer 2003.
| Methods | Randomised control trial ‐ double‐blind and placebo‐controlled cross‐over study | |
| Participants | Outpatients, aged 4‐15 years, with ICD‐10 criteria for Autistic Disorder, with two independent Child and Adolescent Psychiatrists agreeing on the diagnosis | |
| Interventions | Tianeptine compared with placebo | |
| Outcomes | Parent and Teacher Ratings on Symptom Checklist and Aberrant Behaviour Checklist (ABC) Clinician ratings on Childhood Global Assessment Scale, Modified Childhood Psychiatric Rating Scale (CPRS) and Clinical Gllobal Impression scales |
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| Notes | Information presented in abstract that is not included in study report. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No information on the method of randomisation is given ‐ "the subjects were randomly assigned by a non‐rating clinician to begin tianeptine or placebo". |
| Allocation concealment (selection bias) | Unclear risk | No description given of how patients were allocated, but does say that "tianeptine and identical placebo tablets were administered" |
| Blinding (performance bias and detection bias) Participants | Low risk | Identical medications administered |
| Blinding (performance bias and detection bias) Personnel | Low risk | "All raters (parents, teachers and clinicians) were blind to drug order" |
| Blinding (performance bias and detection bias) Outcome assessors | Low risk | "All raters (parents, teachers and clinicians) were blind to drug order" |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants completed the trial so no loss to follow‐up |
| Selective reporting (reporting bias) | High risk | Only parents reports were used to report results, and only selected sections of this were reported in the study. There is no mention of what was done with the clinician ratings, except to say "none of the clinician ratings showed significant differences between placebo and tianeptine, after 6 weeks or after 12 weeks". |
| Other bias | Unclear risk | Risk of bias from cross‐over trial design is low, with appropriate data analysis (two‐tailed t‐tests), and the order of receiving medication was randomised. There was felt to be a small risk of carry‐over effect biasing results as there was a short cross‐over period between treatment arms (one week). |