Carminati 2016.

Methods	Parallel trial of venlafaxine versus placebo
Participants	Inclusion criteria: ICD‐10 diagnosis of intellectual disability from mild to profound (F7X.1) with PDD (F84.X) crisis linked to irritability and agitation (ABC F1 score ≥ 18) and/or hyperactivity/noncompliance (ABC F4 score ≥ 15) aged 18‐45 years Exclusion criteria: epilepsy or any indication against somatic–psychotropic treatments pregnancy Location/setting: University Hospitals of Geneva, Switzerland Sample size: 14 in total, 13 analysed Number of withdrawals/dropouts: 3 participants withdrew consent: 2 at day 14, 1 day 28 but were included in analysis; 1 was not included in analysis due to taking paroxetine during the study Gender: 11/13 were male Mean age: median age venlafaxine group: 22 years (range 18‐30); median age placebo group: 19 (range 19‐32) IQ: all participants had a mild, moderate or severe intellectual disability Baseline ABC‐I or other BoC: ABC‐I median 18.0, self‐injurious behaviour median 8.5; aggression median 5.5 Concomitant medications: psychotropic treatment were prohibited during the trial History of previous medications: not reported
Interventions	Intervention (venlafaxine) for 8 weeks: 18.75 mg/day of venlafaxine Comparator (placebo) for 8 weeks: matching placebo
Outcomes	Primary outcomes: irritability, measured using the ABC‐I (Aman 1985) self‐injurious behaviour, measured using the Behaviour Problem Inventory (BPI)‐Self‐Injurious Behaviour subscale (Rojahn 2001) Aggression, measured using the Behaviour Problem Inventory (BPI)‐Aggression/Destruction subscale (Rojahn 2001) Secondary outcomes: none reported Timing of outcomes assessment: baseline, and weeks 2 and 8
Notes	Study start date: not reported Study end date: not reported Source of funding: “the Unit of Mental Development of the Department of Mental Health and Psychiatry of the Geneva University Hospitals, Geneva, Switzerland and the Foundation Handicap Mental & Société (FHMS), Geneva, Switzerland, (N. CGR 73166 PS‐Venlafaxine). The funding sources had no role in study design; in the collection, analysis and interpretation of data; in the writing of the report; and in the decision to submit the article for publication." Conflicts of interest: none declared