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CompletedNCT00086645Updated Mar 10, 2017

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

A Phase 2 interventional study of citalopram hydrobromide and placebo in Autistic Disorder, sponsored by Boston University. Completed at 6 sites in United States. Open to participants aged 5 Years to 17 Years. Per ClinicalTrials.gov, last updated 2017-03-10.

Sponsored by Boston University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
149
Allocation
Randomized
Ages
5 Years to 17 Years
Sex
All
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Study summary

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

Read the 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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Conditions studied

  • Autistic Disorder

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Keywords

  • Autism
  • Asperger Syndrome
  • Pervasive Developmental Disorder
  • PDD
  • Rituals
  • Compulsions
  • Stereotypy
  • Routines
  • Repetitive behavior
  • SSRI
  • Serotonin
03

In context

Autistic Disorder

1,344 studies on the registry are indexed under Autistic Disorder; 334 are open to participants now.

This study's enrollment of 149 is above the median of 45 across 1,044 interventional studies indexed under Autistic Disorder.

Browse Autistic Disorder studies →

Lead sponsor

Boston University is the lead sponsor of 266 studies on the registry; 37 are open to participants now.

Of its 30 completed or terminated interventional studies of FDA-regulated products, 24 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 17 Years
Sexes eligible
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

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.
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Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
149 participants (actual)

Study arms

  • Experimental
    citalopram hydrobromide

    citalopram hydrobromide, up to 20 mg daily

    Drug: citalopram hydrobromide

  • Placebo comparator
    placebo

    placebo, up to equivalent of 20 mg of active comparator daily

    Other: placebo

Interventions

  • Drugcitalopram hydrobromide

    10mg/5ml solution

    Also known as: celexa

  • Otherplacebo

    up to equivalent of 20 mg of active comparator daily

06

What researchers measure

Primary outcomes

  1. Clinical Global Improvement

    Time frame: Week 12

Secondary outcomes

  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

07

Study locations

6 sites
  • UCLA Neuropsychiatric Institute
    Los Angeles, California 90024, United States
  • Yale University
    New Haven, Connecticut 06510, United States
  • Dartmouth-Hitchcock Medical Center
    Lebanon, New Hampshire 03756, United States
  • North Shore - Long Island Jewish Hospital
    Great Neck, New York 11021, United States
  • Mount Sinai School of Medicine
    New York, New York 10029, United States
  • University of North Carolina Chapel Hill
    Chapel Hill, North Carolina 25714, United States
08

References and documents

Publications

  • King BH, Dukes K, Donnelly CL, Sikich L, McCracken JT, Scahill L, Hollander E, Bregman JD, Anagnostou E, Robinson F, Sullivan L, Hirtz D. Baseline factors predicting placebo response to treatment in children and adolescents with autism spectrum disorders: a multisite randomized clinical trial. JAMA Pediatr. 2013 Nov;167(11):1045-52. doi: 10.1001/jamapediatrics.2013.2698. PubMed 24061784 ↗
  • King BH, Hollander E, Sikich L, McCracken JT, Scahill L, Bregman JD, Donnelly CL, Anagnostou E, Dukes K, Sullivan L, Hirtz D, Wagner A, Ritz L; STAART Psychopharmacology Network. Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior: citalopram ineffective in children with autism. Arch Gen Psychiatry. 2009 Jun;66(6):583-90. doi: 10.1001/archgenpsychiatry.2009.30. PubMed 19487623 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 10, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00086645
Lead sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Sponsor
First posted
Jul 13, 2004
Start date
Apr 2004
Primary completion
Oct 2006
Completion
Apr 2007
Last update
Mar 10, 2017

Study contacts

Bryan King, MD
study chair · University of Washington

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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