This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
149
10mg/5ml solution
up to equivalent of 20 mg of active comparator daily
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
Clinical Global Improvement
Time frame: Week 12
Safety Monitoring Uniform Research Form (SMURF)
Time frame: post-baseline through week 12
Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS)
Time frame: Week 12
Repetitive Behavior Scale-Revised (RBS-R)
Time frame: Week 12
Parent Chief Complaint
Time frame: Weeks 6 and 12
Aberrant Behavior Checklist
Time frame: Week 12
Child and Adolescent Symptom Inventory: Anxiety and Depression scales
Time frame: Week 12
Behavioral Activation
Time frame: post-baseline through Week 12
Caregiver Strain Questionnaire
Time frame: Week 12
Vineland
Time frame: Week 12
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Mount Sinai School of Medicine
New York, New York, United States
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States