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

July 7, 2004
July 13, 2004
March 10, 2017
April 2004
October 2006   (Final data collection date for primary outcome measure)
Clinical Global Improvement [ Time Frame: Week 12 ]
Not Provided
Complete list of historical versions of study NCT00086645 on Archive Site
  • 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 ]
Not Provided
Not Provided
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Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1)
Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior
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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Autistic Disorder
  • Drug: citalopram hydrobromide
    10mg/5ml solution
    Other Name: celexa
  • Other: placebo
    up to equivalent of 20 mg of active comparator daily
  • Experimental: citalopram hydrobromide
    citalopram hydrobromide, up to 20 mg daily
    Intervention: Drug: citalopram hydrobromide
  • Placebo Comparator: placebo
    placebo, up to equivalent of 20 mg of active comparator daily
    Intervention: Other: placebo

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
April 2007
October 2006   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
5 Years to 17 Years   (Child)
Contact information is only displayed when the study is recruiting subjects
United States
U54MH066398( U.S. NIH Grant/Contract )
U54MH066398 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
Boston University
Boston University
National Institute of Mental Health (NIMH)
Study Chair: Bryan King, MD University of Washington
Boston University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP