Effectiveness of Early Intervention With Fluoxetine in Enhancing Developmental Processes in Children With Autism (STAART Study 2) - Tabular View

Tracking Information

First Received Date ^ICMJE

September 6, 2005

Last Updated Date

February 25, 2008

Start Date ^ICMJE

July 2005

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Feasibility and safety of conducting placebo control trial of fluoxetine [ Time Frame: Measured over 12 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Growth curve on the Pervasive Developmental Disorder Behavior Inventory-Parent Version (PDDBIp)subscales; measured over 12 months

Change History

Complete list of historical versions of study NCT00183339 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Side effect and drop out evaluation [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Effectiveness of Early Intervention With Fluoxetine in Enhancing Developmental Processes in Children With Autism (STAART Study 2)

Official Title ^ICMJE

A Randomized, Placebo-Controlled Trial of Fluoxetine in Preschool Children

Brief Summary

This study is a pilot study to evaluate the feasibility and safety of conducting a year long, double-blind, placebo-controlled trial of fluoxetine in pre-school children to enhance developmental processes in core areas impacted by autism.

Detailed Description

Autism, a brain disorder that affects a small percentage of Americans, often results in a lifetime of impaired thinking, feeling, and social functioning. The disorder generally becomes apparent in children by the age of 3. Autism typically affects a person's ability to communicate, form relationships with others, and respond appropriately to the external world. Some people with autism can function at a relatively high level, with speech and intelligence intact. Others have serious cognitive impairments and language delays, and some never speak. This study will assess the safety and effectiveness of treating autistic children with fluoxetine to enhance developmental processes in core areas impacted by autism.

This double-blind study will last a total of 12 months. Participants will be randomly assigned to receive either fluoxetine or placebo. Study visits will be held every two weeks for approximately the first 3 months, or until the dose of medication is stabilized. After this initial period, study visits will be held on a monthly basis, with telephone assessments conducted in the interim periods.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Autistic Disorder

Intervention ^ICMJE

Drug: Fluoxetine
Genetic: Placebo

Study Arms / Comparison Groups

Placebo Comparator: Participants will take the placebo
Experimental: Participants will take fluoxetine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2008

Primary Completion Date

February 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Diagnosis of autism

Exclusion Criteria:

Diagnosis of Asperger Syndrome, Rett Syndrome, Childhood Disintegrative Disorder, or Pervasive Development Disorder-Not Otherwise Specified
Informed that treatment with a selective serotonin reuptake inhibitor (SSRI) is medically inadvisable
Need for ongoing psychotropic medication (except for diphenhydramine, clonidine, or melatonin for sleep)
Recent use of stimulants within 5 days prior to enrollment
Ongoing need for or recent use of most psychotropic medications within 14 days of enrollment
Recent initiation of specialized educational, behavioral, or diet intervention for autism in the month prior to enrollment

Gender

Both

Ages

30 Months to 58 Months

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00183339

Responsible Party

Linmarie Sikich, MD, University of North Carolina, Chapel Hill

Study ID Numbers ^ICMJE

U54 MH66418, U54 MH66673, U54 MH68172, DDTR BD-DD

Study Sponsor ^ICMJE

National Institute of Mental Health (NIMH)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Linmarie Sikich, MD

The University of North Carolina, Chapel Hill

Information Provided By

National Institute of Mental Health (NIMH)

Verification Date

February 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP