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

Autistic Disorder Clinical Trial

Official title:

Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00086645
• Other study ID #: U54MH066398
• Secondary ID: U54MH066398
• Status: Completed
• Phase: Phase 2
• First received: July 7, 2004
• Last updated: March 8, 2017
• Start date: April 2004
• Est. completion date: April 2007

Study information

• Verified date: March 2017
• Source: Boston University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: April 2007
• Est. primary completion date: October 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Drug:
• citalopram hydrobromide
10mg/5ml solution

Other:
• placebo
up to equivalent of 20 mg of active comparator daily

Locations

Country	Name	City	State
United States	University of North Carolina Chapel Hill	Chapel Hill	North Carolina
United States	North Shore - Long Island Jewish Hospital	Great Neck	New York
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire
United States	UCLA Neuropsychiatric Institute	Los Angeles	California
United States	Yale University	New Haven	Connecticut
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Boston University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

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