NCT00086645

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
149

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2004

Typical duration for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2004

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2004

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2006

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

March 10, 2017

Status Verified

March 1, 2017

Enrollment Period

2.5 years

First QC Date

July 7, 2004

Last Update Submit

March 8, 2017

Conditions

Autistic Disorder

Keywords

AutismAsperger SyndromePervasive Developmental DisorderPDDRitualsCompulsionsStereotypyRoutinesRepetitive behaviorSSRISerotonin

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Improvement

    Week 12

Secondary Outcomes (9)

  • Safety Monitoring Uniform Research Form (SMURF)

    post-baseline through week 12

  • Children's Yale-Brown Obsessive-Compulsive Scale (CYBOCS)

    Week 12

  • Repetitive Behavior Scale-Revised (RBS-R)

    Week 12

  • Parent Chief Complaint

    Weeks 6 and 12

  • Aberrant Behavior Checklist

    Week 12

  • +4 more secondary outcomes

Study Arms (2)

citalopram hydrobromide

EXPERIMENTAL

citalopram hydrobromide, up to 20 mg daily

Drug: citalopram hydrobromide

placebo

PLACEBO COMPARATOR

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

Other: placebo

Interventions

citalopram hydrobromideDRUG

10mg/5ml solution

Also known as: celexa
citalopram hydrobromide
placeboOTHER

up to equivalent of 20 mg of active comparator daily

placebo

Eligibility Criteria

Age5 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

UCLA Neuropsychiatric Institute

Los Angeles, California, 90024, United States

Location

Yale University

New Haven, Connecticut, 06510, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

North Shore - Long Island Jewish Hospital

Great Neck, New York, 11021, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, 25714, United States

Location

Related Publications (3)

  • Iffland M, Livingstone N, Jorgensen M, Hazell P, Gillies D. Pharmacological intervention for irritability, aggression, and self-injury in autism spectrum disorder (ASD). Cochrane Database Syst Rev. 2023 Oct 9;10(10):CD011769. doi: 10.1002/14651858.CD011769.pub2.

    PMID: 37811711DERIVED

  • 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.

    PMID: 24061784DERIVED

  • 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.

    PMID: 19487623DERIVED

MeSH Terms

Conditions

Autistic DisorderAsperger SyndromeChild Development Disorders, PervasiveCeremonial BehaviorCompulsive BehaviorStereotypic Movement Disorder

Interventions

Citalopram

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderNeurodevelopmental DisordersMental DisordersSocial BehaviorBehaviorImpulsive Behavior

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsNitrilesBenzofuransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Bryan King, MD

    University of Washington

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2004

First Posted

July 13, 2004

Study Start

April 1, 2004

Primary Completion

October 1, 2006

Study Completion

April 1, 2007

Last Updated

March 10, 2017

Record last verified: 2017-03

Locations

US(6)