Study of Fluoxetine in Autism

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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00515320

Acronym

SOFIA

Enrollment

158

Registered

2007-08-13

Start date

2007-08-31

Completion date

2009-01-31

Last updated

2012-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autistic Disorder

Keywords

Autism, children, adolescent, Fluoxetine, Autistic Disorder, Repetitive behavior, SSRI, Selective Serotonin Reuptake Inhibitor

Brief summary

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.

Interventions

DRUGFluoxetine

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

DRUGPlacebo

Oral dispersible tablet placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 17 Years

Healthy volunteers

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/

Design outcomes

Primary

Measure	Time frame
The percentage change from baseline to the endpoint visit for the CYBOCS-PDD score.	Throughout the study

Secondary

Measure	Time frame
The time and dose related course of therapeutic effects	Throughout the study
The inter-relationship between these effects in the context of global clinical changes.	Throughout the study
The indirect effects on patient caregivers of the dose regime in these subjects compared to placebo during treatment.	Throughout the study
Safety measures will be physical examination, vital signs, EKG/ECG & clinical laboratory tests.	Throughout the study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 26, 2026