Buitelaar 1996.

Methods	Parallel trial of ORG 2766, an ACTH‐(4–9) analog versus placebo
Participants	Inclusion criteria: diagnosis of autistic disorder according to the DSM‐IIIR criteria performance IQ of > 60 on the the Wechsler Intelligence Scale for Children‐Revised aged 7‐15 years Exclusion criteria: taking concurrent psychotropic medications Location/setting: outpatient clinic of the Department of Child and Adolescent Psychiatry of the Utrecht University Hospital, The Netherlands Sample size: 50 (30 to ORG2766 group, 20 to placebo group) Number analysed: 30 ORG 2766; 20 placebo Number of withdrawals/dropouts: 2 on placebo and 1 on ORG 2766 dropped out because of "an increase in anxiety, nervousness and irritability after they had ingested the tablets for 3 weeks, 4 days and 2 days respectively" Gender: not reported Mean age: "aged between 7 and 15 years" IQ: "a performance IQ of more than 60". Concurrent medications: participants could not have been on any concurrent psychotropic medications History of previous medications: details not provided Baseline ABC‐I or other BoC: parent‐rated total ABC score: ORG2766 responders 51.0 (18.5), ORG2766 non‐responders 46.9 (29.5); placebo responders 42.3 (16.4), placebo non‐responders 46.5 (22.5)
Interventions	Intervention: (ORG 2766) for 6 weeks: 40 mg/day of ORG 2766 Comparator: (placebo) for 6 weeks: 40 mg/day of placebo
Outcomes	Primary outcomes: BoC measured using the Teacher‐rated ABC (total score; only ABC total scores provided) AEs (not reported) Secondary outcomes: none reported Timing of outcome assessments: baseline, week 2, 4, and 6 (endpoint)
Notes	Study start date: not reported Study end date: not reported Source of funding: not reported Conflicts of interest: not reported