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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00086645
Recruitment Status : Completed
First Posted : July 13, 2004
Last Update Posted : March 10, 2017
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Boston University

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

Condition or disease Intervention/treatment Phase
Autistic Disorder Drug: citalopram hydrobromide Other: placebo Phase 2

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 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 149 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior
Study Start Date : April 2004
Actual Primary Completion Date : October 2006
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: citalopram hydrobromide
citalopram hydrobromide, up to 20 mg daily
Drug: citalopram hydrobromide
10mg/5ml solution
Other Name: celexa

Placebo Comparator: placebo
placebo, up to equivalent of 20 mg of active comparator daily
Other: placebo
up to equivalent of 20 mg of active comparator daily

Primary Outcome Measures :
  1. Clinical Global Improvement [ Time Frame: Week 12 ]

Secondary Outcome Measures :
  1. Safety Monitoring Uniform Research Form (SMURF) [ Time Frame: post-baseline through week 12 ]
  2. Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS) [ Time Frame: Week 12 ]
  3. Repetitive Behavior Scale-Revised (RBS-R) [ Time Frame: Week 12 ]
  4. Parent Chief Complaint [ Time Frame: Weeks 6 and 12 ]
  5. Aberrant Behavior Checklist [ Time Frame: Week 12 ]
  6. Child and Adolescent Symptom Inventory: Anxiety and Depression scales [ Time Frame: Week 12 ]
  7. Behavioral Activation [ Time Frame: post-baseline through Week 12 ]
  8. Caregiver Strain Questionnaire [ Time Frame: Week 12 ]
  9. Vineland [ Time Frame: Week 12 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00086645

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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
North Shore - Long Island Jewish Hospital
Great Neck, New York, United States, 11021
Mount Sinai School of Medicine
New York, New York, United States, 10029
United States, North Carolina
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, United States, 25714
Sponsors and Collaborators
Boston University
National Institute of Mental Health (NIMH)
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Study Chair: Bryan King, MD University of Washington
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Boston University Identifier: NCT00086645    
Other Study ID Numbers: U54MH066398 ( U.S. NIH Grant/Contract )
U54MH066398 ( U.S. NIH Grant/Contract )
First Posted: July 13, 2004    Key Record Dates
Last Update Posted: March 10, 2017
Last Verified: March 2017
Keywords provided by Boston University:
Asperger Syndrome
Pervasive Developmental Disorder
Repetitive behavior
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents