Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1)
Autistic Disorder
About this trial
This is an interventional treatment trial for Autistic Disorder focused on measuring Autism, Asperger Syndrome, Pervasive Developmental Disorder, PDD, Rituals, Compulsions, Stereotypy, Routines, Repetitive behavior, SSRI, Serotonin
Eligibility Criteria
Inclusion Criteria: 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)). Exclusion Criteria: 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.
Sites / Locations
- UCLA Neuropsychiatric Institute
- Yale University
- Dartmouth-Hitchcock Medical Center
- North Shore - Long Island Jewish Hospital
- Mount Sinai School of Medicine
- University of North Carolina Chapel Hill
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
citalopram hydrobromide
placebo
citalopram hydrobromide, up to 20 mg daily
placebo, up to equivalent of 20 mg of active comparator daily