Status:
COMPLETED
Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1)
Lead Sponsor:
Boston University
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Autistic Disorder
Eligibility:
All Genders
5-17 years
Phase:
PHASE2
Brief Summary
This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism.
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
149 Patients enrolled
Trial Details
Trial ID
NCT00086645
Start Date
April 1 2004
End Date
April 1 2007
Last Update
March 10 2017
Active Locations (6)
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1
UCLA Neuropsychiatric Institute
Los Angeles, California, United States, 90024
2
Yale University
New Haven, Connecticut, United States, 06510
3
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
4
North Shore - Long Island Jewish Hospital
Great Neck, New York, United States, 11021