Early Intervention With Fluoxetine in Autism

NCT00183339 | Completed Phase 2 Results DMC

• 1 other identifier: U54MH066418
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 2

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.

Conditions

Autistic Disorder

Keywords

Autism

Outcome Measures

Primary Outcomes (1)

• Rate of Recruitment

  In order for a larger trial with similar design to be feasible a number of factors needed to be examined. The first was whether families would enroll very young children with ASD into a year long blinded medication study. To determine this we examined the average number of months to randomize 1 participant per site. We calculated this (as total # months required for recruitment\* 2sites ) /\[ # participants randomized \] and compared it to the typical # of months required to recruit an older child with ASD for a double-blind 12 week placebo controlled medication study, which is typically about 1.2 months at each of the sites involved in the study.

  19 months

Secondary Outcomes (3)

• Rate of Attrition

  Measured at Month 12

• Change From Baseline to 12 Months in Total Score on Caregiver Strain Questionnaire

  12 months

• Change From Baseline to Month 12 in Aberrant Behavior Checklist Irritability Subscale Score (ABC-I)

  12 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

fluoxetine

EXPERIMENTAL

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

Drug: Fluoxetine

Interventions

Fluoxetine 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.

Also known as: Prozac

fluoxetine

Placebo 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.

Placebo

Eligibility Criteria

• Age: 30 Months - 58 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of autism

You may not qualify if:

• 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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

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 (1)

• 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: 37811711 DERIVED

MeSH Terms

Conditions

Autistic Disorder

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Autism Spectrum Disorder; Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Limitations and Caveats

It took twice as long to recruit subjects for a study in children 30-58 months than it generally takes to recruit older children. It is possible to maintain subjects in double-blind trails for extended periods.

Results Point of Contact

• Title: Linmarie Sikich, MD
• Organization: University of North Carolina

Lsikich@med.unc.edu

919 966 8653

Study Officials

• Linmarie Sikich, MD

  University of North Carolina, Chapel Hill

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 16, 2005
• Study Start: July 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 26, 2014
• Results First Posted: March 26, 2014

Record last verified: 2014-02

Locations

US (2)