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Autistic DisorderPhase 2NCT00086645

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

A Phase 2 study testing citalopram hydrobromide in people with Autistic Disorder, run by Boston University at 6 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 5 to 17 years
Conditions the study is for
Autistic Disorder
What is being tested?
citalopram hydrobromide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
149 participants
Where
6 sitesUnited States
Study dates
Apr 2004to Apr 2007
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)).

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

United States6 sites

  • University of North Carolina Chapel Hill

    Chapel Hill, North Carolina, 25714

  • North Shore - Long Island Jewish Hospital

    Great Neck, New York, 11021

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • UCLA Neuropsychiatric Institute

    Los Angeles, California, 90024

  • Yale University

    New Haven, Connecticut, 06510

  • Mount Sinai School of Medicine

    New York, New York, 10029

Other trials in United States

About this study

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

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

Read the 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.

Being tested
citalopram hydrobromide, placebo
Keywords
Autism, Asperger Syndrome, Pervasive Developmental Disorder, PDD, Rituals, Compulsions, Stereotypy, Routines, Repetitive behavior, SSRI, Serotonin
Medical subject headings
Autistic Disorder, Asperger Syndrome, Child Development Disorders, Pervasive, Ceremonial Behavior, Compulsive Behavior, Stereotypic Movement Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • citalopram hydrobromideDrug

    Also called celexa

    10mg/5ml solution

  • placeboOther

    up to equivalent of 20 mg of active comparator daily

Study groups in NCT00086645
Study groupRoleWhat they receive
citalopram hydrobromideExperimentalcitalopram hydrobromide, up to 20 mg daily
Receives: Drug: citalopram hydrobromide
placeboPlacebo comparatorplacebo, up to equivalent of 20 mg of active comparator daily
Receives: Other: placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinical Global Improvement

    Measured: Week 12

Secondary outcomes (9)

  1. Safety Monitoring Uniform Research Form (SMURF)

    Measured: post-baseline through week 12

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

    Measured: Week 12

  3. Repetitive Behavior Scale-Revised (RBS-R)

    Measured: Week 12

  4. Parent Chief Complaint

    Measured: Weeks 6 and 12

  5. Aberrant Behavior Checklist

    Measured: Week 12

  6. Child and Adolescent Symptom Inventory: Anxiety and Depression scales

    Measured: Week 12

  7. Behavioral Activation

    Measured: post-baseline through Week 12

  8. Caregiver Strain Questionnaire

    Measured: Week 12

  9. Vineland

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionOct 2006
  4. Study completionApr 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
149 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00086645
Sponsor's protocol ID
U54MH066398
Other IDs
U54MH066398
Status last verified
Mar 2017
First submitted
7 Jul 2004
Last updated
10 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 37811711

  • 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.

    PubMed 24061784

  • 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.

    PubMed 19487623

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing citalopram hydrobromide in people with Autistic Disorder, run by Boston University at 6 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Global Improvement (time frame: Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00086645, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2017.

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