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

Completed · Phase 2 · Has a placebo group

Conditions studied: Autistic Disorder

In brief

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

Key facts

Study ID

NCT00086645

Run by

Boston University

People needed

149

Starts

2004-04-01

Expected to finish

2007-04-01

Last updated by the study team

2017-03-10

Who can join

Age: 5 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 ratings.
• 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)).

You may not qualify if…

• 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.
• Pregnancy
• 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.

Where it is running

• UCLA Neuropsychiatric Institute — Los Angeles, California, United States
• Yale University — New Haven, Connecticut, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• North Shore - Long Island Jewish Hospital — Great Neck, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• University of North Carolina Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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