Autism Speaks, Science, Sponsored Programs, CTN, Clinical Trials Network

How can I find out more about participating in the study?

The SOFIA study has now completed family enrollment.

What is fluoxetine?

Fluoxetine, one of the most widely prescribed central nervous system (CNS) drugs, is a selective serotonin reuptake inhibitor (SSRI) often prescribed to treat depression, anxiety, obsessive-compulsive disorder and other CNS disorders. Fluoxetine is designed to increase serotonin levels in the brain and may therefore address symptoms related to abnormal levels of serotonin observed in individuals with autism.

Isn't fluoxetine another name for Prozac®?

Fluoxetine is the name of the drug compound (generic name). It has been marketed under the brand name Prozac®. The current study is using a new formulation of the drug. This formulation is a proprietary preparation of fluoxetine, featuring autism-specific dosages in a melt-in-the-mouth formulation designed specifically for children and adults with autism.

Fluoxetine has already been in use by doctors for autistic patients. Why is it important for us to study this drug instead of something new?

Fluoxetine is a drug that has been indicated for use for the treatment of depression, anxiety, obsessive-compulsive disorder and other CNS disorders.

Because of this, it has long safety record in both adult and pediatric populations. Many doctors, using their clinical judgment, prescribe the medicine to children and adolescents with autism to relieve autistic symptoms (this is called an “off-label” use). While the existing clinical data is positive, there have been relatively few well-controlled double-blind studies (studies that include a group taking active medicine and a comparison group taking a placebo, or inactive sugar pill) of the effects of the drug in children and adolescents with autism. This new formulation features autism-specific dosages in a melt-in-the-mouth format designed specifically for children and adults with autism. This study aims to measure the efficacy of the drug in reducing specific autistic symptoms.

Who is Neuropharm?

Neuropharm Group Plc is a specialty pharmaceutical company focused on the development of products for the treatment of disorders of the central nervous system (CNS).

You can find more information on the Neuropharm at www.neuropharm.co.uk.