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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Functional MRI Evaluation of the Effect of Citalopram in Autism Spectrum Disorders

NCT00609531

Autism Spectrum Disorders

COMPLETED PHASE1

Brain Response to Serotonergic Medications in ASD

NCT04145076

Autism Spectrum Disorder

UNKNOWN NA

Citalopram vs Clomipramine vs Placebo in Recurrent Depression

NCT01575158

Depression

COMPLETED NA

Drug Therapy to Treat Minor Depression

NCT00048815

Depression

COMPLETED NA

Citalopram and Stress Reactivity

NCT04161209

Depression Depressive Disorder Mental Disorder +3 more

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autistic Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

citalopram hydrobromide

citalopram hydrobromide, up to 20 mg daily

Group Type EXPERIMENTAL

citalopram hydrobromide

Intervention Type DRUG

10mg/5ml solution

placebo

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

up to equivalent of 20 mg of active comparator daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

citalopram hydrobromide

10mg/5ml solution

Intervention Type DRUG

placebo

up to equivalent of 20 mg of active comparator daily

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

celexa

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

5 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No