Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1)

Summary

This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism.

Timeline

Start

2004-04

Primary completion

2006-10

Completion

2007-04

Outcome

Missed primary endpoint

paper citalopram-treated group (32.9%) and the placebo group (34.2%) (relative risk, 0.96; 95% confidence interval, 0.61-1.51; P > .99). PMID 19487623 ↗

paper Results of this trial do not support the use of citalopram for the treatment of repetitive behavior in children and adolescents with autism spectrum disorders. PMID 19487623 ↗

Publications

• Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.
• King BH, Dukes K, Donnelly CL, Sikich L, McCracken JT, Scahill L, Hollander E, Bregman JD, Anagnostou E, Robinson F, Sullivan L, Hirtz D. Baseline factors predicting placebo response to treatment in children and adolescents with autism spectrum disorders: a multisite randomized clinical trial. JAMA Pediatr. 2013 Nov;167(11):1045-52. doi: 10.1001/jamapediatrics.2013.2698.
• King BH, Hollander E, Sikich L, McCracken JT, Scahill L, Bregman JD, Donnelly CL, Anagnostou E, Dukes K, Sullivan L, Hirtz D, Wagner A, Ritz L; STAART Psychopharmacology Network. Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior: citalopram ineffective in children with autism. Arch Gen Psychiatry. 2009 Jun;66(6):583-90. doi: 10.1001/archgenpsychiatry.2009.30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Citalopram	Small molecule	20 mg	Oral

Indications