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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00086645 |
This study will determine the efficacy and safety of citalopram compared to placebo in the treatment of children with autism.
Condition | Intervention | Phase |
---|---|---|
Autistic Disorder |
Drug: citalopram |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior |
Enrollment: | 149 |
Study Start Date: | April 2004 |
Study Completion Date: | April 2007 |
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.
Ages Eligible for Study: | 5 Years to 17 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
UCLA Neuropsychiatric Institute | |
Los Angeles, California, United States, 90024 | |
United States, Connecticut | |
Yale University | |
New Haven, Connecticut, United States, 06510 | |
United States, New Hampshire | |
Dartmouth-Hitchcock Medical Center | |
Lebanon, New Hampshire, United States, 03756 | |
United States, New York | |
Mount Sinai School of Medicine | |
New York, New York, United States, 10029 | |
North Shore - Long Island Jewish Hospital | |
Great Neck, New York, United States, 11021 | |
United States, North Carolina | |
University of North Carolina Chapel Hill | |
Chapel Hill, North Carolina, United States, 25714 |
Study Chair: | Bryan King, MD | University of Washington |
Study ID Numbers: | U54 MH66398, DDTR BD-DD |
Study First Received: | July 7, 2004 |
Last Updated: | April 14, 2008 |
ClinicalTrials.gov Identifier: | NCT00086645 |
Health Authority: | United States: Federal Government |
Autism Asperger Syndrome Pervasive Developmental Disorder PDD Rituals Compulsions |
Stereotypy Routines Repetitive behavior SSRI Serotonin |
Child Development Disorders, Pervasive Developmental Disabilities Compulsive Behavior Mental Disorders Autistic Disorder |
Mental Disorders Diagnosed in Childhood Asperger Syndrome Dexetimide Citalopram Serotonin |
Parasympatholytics Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Disease Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Psychotropic Drugs Antiparkinson Agents Cholinergic Agents |
Serotonin Uptake Inhibitors Pharmacologic Actions Muscarinic Antagonists Pathologic Processes Serotonin Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Antidepressive Agents, Second-Generation Central Nervous System Agents Antidepressive Agents |