NCT00027404

Brief Summary

This is a study to determine the effect of fluoxetine in the treatment of adult autism and on functional ability and behavior associated with autism. Evidence suggests abnormal serotonin function in autism. Fluoxetine is a selective inhibitor of the serotonin transporter.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 7, 2001

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2005

Completed
Last Updated

March 25, 2015

Status Verified

November 1, 2002

First QC Date

December 5, 2001

Last Update Submit

March 24, 2015

Conditions

Autistic Disorder

Keywords

Adult, Autism

Interventions

FluoxetineDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Meets DSM-IV and ADI criteria for autistic disorder
  • Patients must use effective contraception
  • Negative pregnancy test
  • Clinical Global Impression-Severity Scale for Autistic Disorder (CGI-AD) score of 4

You may not qualify if:

  • Pregnant or nursing
  • Prior or concurrent history of mental disorders, including schizophrenia, schizoaffective disorder, organic mental disorders, or bipolar disorders
  • Concurrent depression determined by DSM-IV diagnosis
  • Serious suicidal risk
  • Active seizure disorder within the past 2 years
  • Clinically significant or unstable medical illness, including hematopoietic or cardiovascular disease
  • Any organic or systemic disease
  • Any geographical condition that would preclude study compliance
  • Prior or concurrent gastrointestinal, liver, or kidney disease
  • Any other concurrent condition that interferes with the absorption, distribution, metabolism, or excretion of drugs
  • Prior or concurrent cerebrovascular disease or brain trauma
  • Prior or concurrent clinically significant unstable endocrine disorder, such as hypo- or hyperthyroidism
  • Prior or concurrent malignancy
  • Clinically significant abnormalities on EKG, laboratory tests, or physical exam
  • Requirement for ECT or any other psychotropic medication
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Autistic Disorder

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Autism Spectrum DisorderChild Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic Chemicals

Study Officials

  • Eric Hollander, MD

    Mount Sinai School of Medicine New York, New York, United States

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2001

First Posted

December 7, 2001

Study Start

September 1, 2001

Study Completion

August 1, 2005

Last Updated

March 25, 2015

Record last verified: 2002-11

Locations

US(1)