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Completed

NCT Number: NCT00515320

Study of Fluoxetine in Autism

The purpose of this study is to assess the effect of fluoxetine orally dissolving tablets (ODT) on the repetitive behaviors core domain in children and adolescents with Autistic Disorder. The study will also investigate the effect of fluoxetine on the improvement of symptoms and the effects on daily living of the patient's family.

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Key information

Conditions

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

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Southwest Autism Research and Resource Centre, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Meets DSM-IV criteria for autistic disorder, .
  • CYBOCS-PDD score of at least 10 at screening.

Exclusion criteria

  • Diagnosis of Asperger Syndrome or Pervasive Developmental Disorder Not Otherwise Specified, Rett Syndrome, Childhood Disintegrative Disorder.
  • Patients planning to commence cognitive behaviour therapy during the period of the study or those who have begun cognitive behaviour therapy within 8 weeks prior to enrolment.
  • Patients who are currently taking fluoxetine or who have previously taken it are not eligible for the study.

Other protocol-defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

Fluoxetine

Drug

Once daily oral dispersible tablet 2mg 9mg or 18mg

Other names: NPL-2008

Placebo

Drug

Oral dispersible tablet placebo

Primary outcomes

  1. The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.

    Time frame: Throughout the study

Secondary outcomes

  1. The time and dose related course of therapeutic effects

    Time frame: Throughout the study

  2. The inter-relationship between these effects in the context of global clinical changes.

    Time frame: Throughout the study

  3. The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment.

    Time frame: Throughout the study

  4. Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.

    Time frame: Throughout the study

Sponsors and collaborators

Lead sponsor

Neuropharm

Industry

Collaborators

  • Autism Speaks

Registry information

Official study title

Study Of Fluoxetine In Autism: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group 14-Week Study To Investigate The Effect Of Fluoxetine Orally Dissolving Tablet (ODT) On Repetitive Behaviors In Childhood And Adolescent Autistic Disorder.

Acronym: SOFIA

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Aug 13, 2007
Registry last updated
Apr 27, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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