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

This study has been completed.
Sponsor:
Information provided by:
National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier:
NCT00086645
First received: July 7, 2004
Last updated: April 14, 2008
Last verified: April 2008
  Purpose

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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior

Resource links provided by NLM:


Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Clinical Global Improvement [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Monitoring Uniform Research Form (SMURF) [ Time Frame: post-baseline through week 12 ] [ Designated as safety issue: Yes ]
  • Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Repetitive Behavior Scale-Revised (RBS-R) [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Parent Chief Complaint [ Time Frame: Weeks 6 and 12 ] [ Designated as safety issue: No ]
  • Aberrant Behavior Checklist [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Child and Adolescent Symptom Inventory: Anxiety and Depression scales [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Behavioral Activation [ Time Frame: post-baseline through Week 12 ] [ Designated as safety issue: Yes ]
  • Caregiver Strain Questionnaire [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
  • Vineland [ Time Frame: Week 12 ] [ Designated as safety issue: No ]

Enrollment: 149
Study Start Date: April 2004
Study Completion Date: April 2007
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.

  Eligibility

Ages Eligible for Study:   5 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086645

Locations
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
Investigators
Study Chair: Bryan King, MD University of Washington
  More Information

No publications provided by National Institute of Mental Health (NIMH)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00086645     History of Changes
Other Study ID Numbers: U54 MH66398, DDTR BD-DD
Study First Received: July 7, 2004
Last Updated: April 14, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Autism
Asperger Syndrome
Pervasive Developmental Disorder
PDD
Rituals
Compulsions
Stereotypy
Routines
Repetitive behavior
SSRI
Serotonin

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Citalopram
Dexetimide
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Parasympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents

ClinicalTrials.gov processed this record on April 16, 2014