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

Primary Purpose

Autistic Disorder

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
citalopram hydrobromide
placebo
Sponsored by
Boston University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autistic Disorder focused on measuring Autism, Asperger Syndrome, Pervasive Developmental Disorder, PDD, Rituals, Compulsions, Stereotypy, Routines, Repetitive behavior, SSRI, Serotonin

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UCLA Neuropsychiatric Institute
  • Yale University
  • Dartmouth-Hitchcock Medical Center
  • North Shore - Long Island Jewish Hospital
  • Mount Sinai School of Medicine
  • University of North Carolina Chapel Hill

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

citalopram hydrobromide

placebo

Arm Description

citalopram hydrobromide, up to 20 mg daily

placebo, up to equivalent of 20 mg of active comparator daily

Outcomes

Primary Outcome Measures

Clinical Global Improvement

Secondary Outcome Measures

Safety Monitoring Uniform Research Form (SMURF)
Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS)
Repetitive Behavior Scale-Revised (RBS-R)
Parent Chief Complaint
Aberrant Behavior Checklist
Child and Adolescent Symptom Inventory: Anxiety and Depression scales
Behavioral Activation
Caregiver Strain Questionnaire
Vineland

Full Information

First Posted
July 7, 2004
Last Updated
March 8, 2017
Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT00086645
Brief Title
Citalopram for Children With Autism and Repetitive Behavior (STAART Study 1)
Official Title
Citalopram Treatment in Children With Autism Spectrum Disorders and High Levels of Repetitive Behavior
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autistic Disorder
Keywords
Autism, Asperger Syndrome, Pervasive Developmental Disorder, PDD, Rituals, Compulsions, Stereotypy, Routines, Repetitive behavior, SSRI, Serotonin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
149 (Actual)

8. Arms, Groups, and Interventions

Arm Title
citalopram hydrobromide
Arm Type
Experimental
Arm Description
citalopram hydrobromide, up to 20 mg daily
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo, up to equivalent of 20 mg of active comparator daily
Intervention Type
Drug
Intervention Name(s)
citalopram hydrobromide
Other Intervention Name(s)
celexa
Intervention Description
10mg/5ml solution
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
up to equivalent of 20 mg of active comparator daily
Primary Outcome Measure Information:
Title
Clinical Global Improvement
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Safety Monitoring Uniform Research Form (SMURF)
Time Frame
post-baseline through week 12
Title
Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS)
Time Frame
Week 12
Title
Repetitive Behavior Scale-Revised (RBS-R)
Time Frame
Week 12
Title
Parent Chief Complaint
Time Frame
Weeks 6 and 12
Title
Aberrant Behavior Checklist
Time Frame
Week 12
Title
Child and Adolescent Symptom Inventory: Anxiety and Depression scales
Time Frame
Week 12
Title
Behavioral Activation
Time Frame
post-baseline through Week 12
Title
Caregiver Strain Questionnaire
Time Frame
Week 12
Title
Vineland
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bryan King, MD
Organizational Affiliation
University of Washington
Official's Role
Study Chair
Facility Information:
Facility Name
UCLA Neuropsychiatric Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
North Shore - Long Island Jewish Hospital
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
University of North Carolina Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
25714
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24061784
Citation
King BH, Dukes K, Donnelly CL, Sikich L, McCracken JT, Scahill L, Hollander E, Bregman JD, Anagnostou E, Robinson F, Sullivan L, Hirtz D. Baseline factors predicting placebo response to treatment in children and adolescents with autism spectrum disorders: a multisite randomized clinical trial. JAMA Pediatr. 2013 Nov;167(11):1045-52. doi: 10.1001/jamapediatrics.2013.2698.
Results Reference
derived
PubMed Identifier
19487623
Citation
King BH, Hollander E, Sikich L, McCracken JT, Scahill L, Bregman JD, Donnelly CL, Anagnostou E, Dukes K, Sullivan L, Hirtz D, Wagner A, Ritz L; STAART Psychopharmacology Network. Lack of efficacy of citalopram in children with autism spectrum disorders and high levels of repetitive behavior: citalopram ineffective in children with autism. Arch Gen Psychiatry. 2009 Jun;66(6):583-90. doi: 10.1001/archgenpsychiatry.2009.30.
Results Reference
derived

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

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