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

March 8, 2017 updated by: Boston University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

149

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 15 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: citalopram hydrobromide
citalopram hydrobromide, up to 20 mg daily
Drug: citalopram hydrobromide
10mg/5ml solution
Other Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Improvement
Time Frame: Week 12
Week 12

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety Monitoring Uniform Research Form (SMURF)
Time Frame: post-baseline through week 12
post-baseline through week 12
Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS)
Time Frame: Week 12
Week 12
Repetitive Behavior Scale-Revised (RBS-R)
Time Frame: Week 12
Week 12
Parent Chief Complaint
Time Frame: Weeks 6 and 12
Weeks 6 and 12
Aberrant Behavior Checklist
Time Frame: Week 12
Week 12
Child and Adolescent Symptom Inventory: Anxiety and Depression scales
Time Frame: Week 12
Week 12
Behavioral Activation
Time Frame: post-baseline through Week 12
post-baseline through Week 12
Caregiver Strain Questionnaire
Time Frame: Week 12
Week 12
Vineland
Time Frame: Week 12
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Study Chair: Bryan King, MD, University of Washington

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

April 1, 2007

Study Registration Dates

First Submitted

July 7, 2004

First Submitted That Met QC Criteria

July 12, 2004

First Posted (Estimate)

July 13, 2004

Study Record Updates

Last Update Posted (Actual)

March 10, 2017

Last Update Submitted That Met QC Criteria

March 8, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U54MH066398 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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