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

Further Study Details: 

Expected Total Enrollment:  144

Ages Eligible for Study:  5 Years   -   17 Years,  Genders Eligible for Study:  Both

Criteria

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.

California
      UCLA Neuropsychiatric Institute, Los Angeles,  California,  90024,  United States; Recruiting
Connecticut
      Yale University, New Haven,  Connecticut,  06510,  United States; Recruiting
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
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)   

Study ID Numbers:  1U54MH066398-01 A1
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  July 7, 2004
ClinicalTrials.gov Identifier:  NCT00086645
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08