Secretin for the Treatment of Autism

• Status: Completed
• Trial end date: 2000-05-01
• Target enrollment: 0
• Participant gender: All

Summary

Many drugs used to treat autism target specific symptoms, such as hyperactivity and aggressiveness. Few drugs target the core autistic symptoms of impaired social interaction and communication. This study will evaluate two forms of the drug secretin for the treatment of core autistic symptoms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborator: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Treatments: Secretin

Criteria

Inclusion Criteria

• Autism based on DSM-IV criteria

• IQ > 35

• Medically fit for the study in the judgment of the study officials

Exclusion Criteria

• Prior administration of secretin

• Acute or chronic pancreatitis

• Use of anticholinergics within 72 hours of study entry or anticipated need for anticholinergics during study

• Allergies to pork products

• Use of investigational drug within 1 month of study entry

• Change in any medication or other therapeutic modality being used to treat any neurodevelopmental or gastrointestinal symptoms of the underlying autism disorder within 1 month of study entry

• Any medical condition which, in the judgment of the investigator, would make the patient unable to safely participate in the study or comply with all study procedures

• Any medical diagnosis which could account for autistic spectrum disorder (i.e., Rett syndrome, Fragile X, tuberous sclerosis, disintegrative disorder, epilepsy, Landau Kleffner, other mental retardation syndromes, or history of severe motor delays or current sensory or motor impairment such as cerebral palsy)

• Hearing or visual impairments

• Use of psychotropic medications (except for occasional symptomatic use for sleep, etc.) within 6 months of study entry