Citalopram for Children with Autism and Repetitive Behavior
This study is currently recruiting patients.
Purpose
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, and severe tantrums and even self-injury can occur when these behaviors and routines are interrupted.
The primary aim of this study is to determine the efficacy in improving global functioning, as well as the tolerability and
safety of citalopram, a selective serotonin reuptake inhibitor (SSRI), as compared to placebo in the treatment of children
with a diagnosis of an autism spectrum disorder.
Condition
|
Treatment or Intervention |
Phase |
Autism Autistic Disorder Asperger Syndrome Pervasive Developmental Disorder PDD
|
Drug: citalopram
|
Phase II
|
MedlinePlus related topics: Asperger's Syndrome; Autism; Mental Health
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title: Citalopram Treatment in Children with Autism Spectrum Disorders and High Levels of Repetitive Behavior
Further Study Details:
Expected Total Enrollment:
144
Study start: April 2004;
Study completion: March 2007
Eligibility
Ages Eligible for Study:
5 Years
-
17 Years,
Genders Eligible for Study:
Both
Inclusion Criteria:
- Able to walk
- Diagnosis of Autistic Disorder, Asperger’s Disorder, or PDD-NOS as determined by ADI-R administered by raters who are trained
to research reliability, and confirmed by an experienced and reliable clinician using DSM-IV-TR criteria.
- 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 (i.e., 4 or greater (>)) behavioral disturbance based on the modified Clinical Global Impression-Severity
of Illness score (CGI-S) at the time of screening (See description below).
- Demonstrate a mental age greater than or equal to (>) 18 months as determined by the Vineland Adaptive Behavior Scales.
- 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 history of an 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 (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, or clinically significant abnormal baseline laboratory testing.
- Known personal history of bipolar disorder or prior manic episode induced by antidepressant exposure.
- Documented need for other 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.
Location
and Contact
Information
California UCLA Neuropsychiatric Institute, Los Angeles,
California,
90024,
United States; Recruiting
Connecticut Yale University, New Haven,
Connecticut,
06510,
United States; Recruiting
Erin Kustan, ,BS
203-785-2508
erin.kustan@yale.edu
Lawrence Scahill, MSN, PhD, Principal Investigator
New Hampshire Dartmouth-Hitchcock Medical Center, Lebanon,
New Hampshire,
03756,
United States; Recruiting
New York Mount Sinai School of Medicine, New York,
New York,
10029,
United States; Recruiting
North Shore - Long Island Jewish Hospital, Great Neck,
New York,
11021,
United States; Recruiting
May-Lynn Andresan, RN
516-802-8603
mandrese@nshs.edu
Joel D Bregman, MD, Principal Investigator
North Carolina University of North Carolina Chapel Hill, Chapel Hill,
North Carolina,
25714,
United States; Recruiting
Study chairs or principal investigators
Deborah Hirtz, MD, Study Director, National Institute of Neurological Disorders and Stroke (NINDS)
Ann Wagner, PhD, Study Director, National Institute of Mental Health (NIMH)
More Information
Study ID Numbers:
1U54MH066398-01 A1
Record last reviewed:
July 2004
Record first received:
July 7, 2004
ClinicalTrials.gov Identifier:
NCT00086645Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08