Extended Management and Measurement of Autism

NCT00787111 | Terminated Phase 3

• 1 other identifier: NPL-2008-4-AUTUS-005
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 13

Brief Summary

This open-label research study will continue to monitor the safety of fluoxetine in children after their completion of a previous double-blind placebo controlled clinical study, with fluoxetine. The study will also look at the effect of fluoxetine on IQ (Intelligence Quotient) over an 18 month period.

Conditions

Autistic Disorder

Keywords

Drug: Fluoxetine

Outcome Measures

Primary Outcomes (1)

• Safety Outcomes: Laboratory determinations, Urine drugs of abuse tests,Vital Signs,Physical Examinations, Adverse Events/Serious Adverse Events, Clinical Global Impression of Severity (CGI-S AD)

  through the study

Study Arms (1)

Fluoxetine ODT

EXPERIMENTAL

Fluoxetine ODT ranging from 2mg to 54mg

Drug: Fluoxetine (prozac)

Interventions

Fluoxetine (prozac) DRUG

Formulation: ODT

Fluoxetine ODT

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients must have been free of fluoxetine and other SSRI's for 4 weeks prior to the first dose of open-label medication (washout).
• Female patients who have reached menarche must have a negative pregnancy test at baseline and as required, in the opinion of the Investigator.
• Females of childbearing potential must be using a medically accepted means of contraception not affected by fluoxetine treatment, or must remain abstinent for the duration of the study.
• Patients must be able to follow the Investigator's instructions and be able to comply with visit requirements
• Each Legally Authorized Representative (usually parent or guardian) must have a level of understanding sufficient to provide written informed consent to all required tests and procedures.
• As required by the local or central IRB, the patient should assent to all required tests and procedures.

You may not qualify if:

• Patients who experienced a serious adverse event during the double-blind SOFIA Study which was determined to be related to the study medication by the Investigator or the sponsor
• Patients who were unable to tolerate the lowest dose of study medication in the double-blind SOFIA study (2mg fluoxetine or placebo) should not be enrolled in this study
• Diagnosis of Rett Syndrome, Childhood Disintegrative Disorder
• Patients currently taking psychotropic medication are excluded. Patients can be enrolled in the study if the psychotropic medication has been completely withdrawn prior to the baseline visit; for at least two weeks for neuroleptics / atypical antipsychotics and for at least 5 days for stimulants
• Patients exhibiting high levels of aggression, irritability or self injurious behavior to the extent that in the Investigator's opinion the patient would be more appropriately treated with psychotropic medication other than fluoxetine such as an atypical antipsychotic
• Patients currently taking a monoamine oxidase inhibitor. Patients who have stopped taking an irreversible MAOI should be free of medication for at least 2 weeks prior to the baseline visit and medication free for at least one day after stopping a reversible MAOI A.
• Patients with diabetes who are treated with insulin
• Patients currently taking tramadol, triptans (e.g.sumatriptan), lithium, tryptophan, haloperidol, clozapine, flecainide or encainide, vinblastine, carbamazepine, tricyclic antidepressants, phenytoin or warfarin are also excluded from the study.
• Current treatment with the herbal remedy, St John's Wort (Hypericum perforatum)
• History of, or current cardiovascular, renal, hepatic, respiratory and particularly gastrointestinal disease which may interfere with the absorption, distribution, metabolism or excretion of the study medication.
• History of, or current cerebrovascular disease or brain trauma.
• History of, or current significant endocrine disorder, e.g. hypo or hyperthyroidism.
• History of or current malignancy.
• Presence of psychotic symptoms or lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder, as assessed by the Investigator.
• Judged clinically to be at risk of suicide (suicidal ideation, severe depression, or other factors), as assessed by the Investigator.

Sponsors & Collaborators

• Neuropharm: lead
• Autism Speaks: collaborator

Study Sites (13)

Southwest Autism Research and Resource Centre

Phoenix, Arizona, 85006, United States

Location

University of California Davis

Sacramento, California, 95817, United States

Location

Institute for Behavioral Medicine

Smyrna, Georgia, 30080, United States

Location

University of Illinois

Chicago, Illinois, 60637-1448, United States

Location

AMR-Baber Research Inc.

Naperville, Illinois, 60563, United States

Location

Harvard Medical School

Medford, Massachusetts, 02155, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

CRCNJ

Voorhees Township, New Jersey, 08043, United States

Location

Long Island Jewish Hospital

Bethpage, New York, 11714, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

University of North Carolina

Chapel Hill, North Carolina, 27514, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Seattle Children's Hosptial University of Washington

Seattle, Washington, 98105-0371, United States

Location

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 5, 2008
• First Posted: November 7, 2008
• Study Start: November 1, 2008
• Primary Completion: April 1, 2009
• Study Completion: April 1, 2009
• Last Updated: February 23, 2010

Record last verified: 2010-02

Locations

US (13)