Early Intervention With Fluoxetine in Autism

NCT ID: NCT00183339

Last Updated: 2014-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-07-31
• Study Completion Date: 2008-02-29

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.

Each participant was randomly assigned to treatment with double-blinded placebo or fluoxetine for 12 months. After initial screening and randomization, participants were assessed every two weeks for approximately the first 3 months, or until the dose of medication is stabilized. After this initial period, they were assessed on a monthly basis. Dosing was flexible as determined by the adverse and beneficial responses to treatment although there was a suggested titration schedule.

Conditions

Autistic Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo, liquid solution flexible dose 0.5 to 5ml every morning (AM)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.

fluoxetine

Fluoxetine, 20mg/5ml solution, flexible dose 0.5 to 5ml every AM

Group Type: EXPERIMENTAL

Fluoxetine

Intervention Type: DRUG

Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.

Interventions

Fluoxetine

Between 2 mg per day and 20 mg per day of liquid fluoxetine will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.

Intervention Type: DRUG

Placebo

Between 0.5ml per day and 5ml per day of liquid placebo will be given in the morning using a flexible dosing strategy, following a 36-week dose titration schedule.

Intervention Type: DRUG

Other Intervention Names

Prozac

Eligibility Criteria

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

• Minimum Eligible Age: 30 Months
• Maximum Eligible Age: 58 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Linmarie Sikich, MD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Linmarie Sikich, MD

Role: STUDY_CHAIR

University of North Carolina, Chapel Hill

Locations

Mount Sinai School of Medicine

New York, New York, United States

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37811711 (View on PubMed)

Other Identifiers

U54MH066418

Identifier Type: NIH

Identifier Source: secondary_id

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U54MH066418

Identifier Type: NIH

Identifier Source: org_study_id

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