Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1)
Information source: National Institute of Mental Health (NIMH)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Autistic Disorder
Intervention: citalopram (Drug)
Phase: Phase 2
Sponsored by: National Institute of Mental Health (NIMH)
Official(s) and/or principal investigator(s):
Bryan King, MD, Study Chair, Affiliation: University of Washington
This study will determine the efficacy and safety of citalopram compared to placebo in the
treatment of children with autism.
Official title: Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Clinical Global Improvement
Safety Monitoring Uniform Research Form (SMURF)
Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS)
Repetitive Behavior Scale-Revised (RBS-R)
Parent Chief Complaint
Aberrant Behavior Checklist
Child and Adolescent Symptom Inventory: Anxiety and Depression scales
Caregiver Strain Questionnaire
For children with autism spectrum disorders (ASD, also known as Pervasive Developmental
Disorders - PDDs), repetitive behaviors are common and frequently interfere with functioning
in the home as well as in social and educational settings. These behaviors may involve
repetitive movements, rigid routines, repetitive play, and even repetitive speech. These
behaviors may be associated with high levels of anxiety, severe tantrums. Self-injury can
occur when these behaviors and routines are interrupted.
Participants will be randomly assigned to receive citalopram or placebo (administered as
liquid), and carefully followed every two weeks. At the end of 12 weeks, children who have
responded to treatment will be given the opportunity to continue in the study, with monthly
visits, for an additional 24 weeks. Children who received placebo and did not respond to
treatment at 12 weeks will be given the opportunity to receive a carefully monitored 12 week
course of citalopram.
Minimum age: 5 Years.
Maximum age: 17 Years.
- Able to walk
- Diagnosis of Autistic Disorder, Asperger's Disorder, or PDD-NOS
- Have a score greater than or equal to (>) 8 on the sum of items 1A, 2, 3 and 5 of the
Compulsions Subscale of the Revised CYBOCS.
- Have a rating of at least moderate behavioral disturbance based on the modified
Clinical Global Impression-Severity of Illness score (CGI-S) at the time of screening
(See description below).
- Be free of psychotropic medication for at least one month for fluoxetine, two weeks
for other SSRIs and neuroleptics, and for 5 days for stimulants prior to baseline
- Be judged reliable for medication compliance and agree to keep appointments for study
contacts and tests as outlined in the protocol (both subject and guardian(s)).
- Medical contraindications to therapy with SSRIs
- Prior exposure to citalopram (or escitalopram) of sufficient dose or duration to
determine response status
- History of treatment failure to a clinically adequate trial of two select SSRIs
- Diagnosis of Rett's Disorder or Childhood Disintegrative Disorder
- Uncontrolled epilepsy, with a seizure within past 6 months
- Child weighs less than (<) 15 kg at screening contact.
- Presence of chronic medical conditions that might interfere with study participation
or where study participation would be contraindicated
- Clinically significant abnormal baseline laboratory testing
- History of bipolar disorder or manic episode induced by antidepressant exposure
- Documented need for ongoing psychotropic medications besides study medication (with
the exception of stable dose (at least 3 month) anti-convulsants for seizures).
- Concomitant medication that would interfere with participation in the study.
- Recent (< 2 months) initiation of behavior therapy (such as parent training, applied
behavior analysis or behavior modification) in a clinic, with a private practitioner
or in a school program. Participants who are in an established behavior therapy
program (defined as greater than (>) 2 months for clinic or private practitioner or
greater than (>) 1 month for school program) can be included in the study. Families
will be asked not to initiate any new behavior therapy during the study.
Locations and Contacts
UCLA Neuropsychiatric Institute, Los Angeles, California 90024, United States
Yale University, New Haven, Connecticut 06510, United States
Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire 03756, United States
Mount Sinai School of Medicine, New York, New York 10029, United States
North Shore - Long Island Jewish Hospital, Great Neck, New York 11021, United States
University of North Carolina Chapel Hill, Chapel Hill, North Carolina 25714, United States
Starting date: April 2004
Ending date: April 2007
Last updated: April 14, 2008