COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Secretin for the Treatment of Autism

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00065962
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : June 24, 2005
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Brief 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.

Condition or disease Intervention/treatment Phase
Autism Drug: secretin, synthetic porcine Drug: secretin, biologically derived porcine Phase 3

Detailed Description:

Autism is a disorder characterized by impairments of social interactions, verbal and nonverbal communication, and preoccupation with unusual activities or interests, particularly stereotyped or repetitive movements. This debilitating disorder is estimated to occur in 2 to 10 of every 10,000 births. A primary focus in pyschopharmacological intervention has been to treat specific associated symptoms, such as hyperactivity, aggressiveness, and temper tantrums; there are few pharmacologic treatments directed toward core autistic symptoms.

Secretin is a gut hormone with binding sites in the brain. Previous research has described three patients with autism who underwent diagnostic endoscopy for gastrointestinal complaints and experienced dramatic improvement in autistic symptoms following the administration of intravenous secretin given as part of endoscopy. Though the results of this single, uncontrolled study have limited interpretive value, many autistic children have been exposed and continue to be exposed to this potential treatment in an uncontrolled manner. This double blind, placebo-controlled trial will evaluate the safety and efficacy of secretin for the treatment of autism.

Participants will be randomly assigned to one of three treatment groups: synthetic porcine secretin (sPS), biologically derived porcine secretin (bPS), or placebo. Each participant will be given an initial intravenous dose of 0.1 ml of their assigned treatment at the appropriate dose (0.2 ug for sPS and 1 CU for bPS). If no allergic reaction occurs within one minute, the participants will continue in the study and receive the full remaining dose over one minute. Participants will be evaluated one week before and four weeks after infusion for social, communication, and behavioral functioning as measured by Autistic Diagnostic Observation Schedule Generic (by blinded raters); Rimland Questionnaires (by parents and teachers); Expressive Vocabulary Test; MacArthur Communication Inventory (by parents and teachers); and Aberrant Behavior Checklist (by parents and teachers). Participants will also have a physical exam and blood and urine tests. After completion of preliminary data analysis, placebo patients will be offered open label therapy if appropriate.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multisite Controlled Secretin Trial in Autism
Study Start Date : June 1999
Study Completion Date : May 2000

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00065962

Layout table for location information
United States, Colorado
Children's Hospital
Denver, Colorado, United States, 80218
United States, Washington
Center on Human Development and Disability
Seattle, Washington, United States, 98195-1525
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Layout table for investigator information
Study Director: Alan Unis, MD University of Washington
Principal Investigator: Geraldine Dawson, PhD University of Washington
Study Director: Edward Goldson, MD University of Colorado, Denver
Principal Investigator: Sally Rogers, PhD University of Colorado, Denver
Layout table for additonal information Identifier: NCT00065962    
Other Study ID Numbers: 5P01HD035465 ( U.S. NIH Grant/Contract )
5P01HD035465 ( U.S. NIH Grant/Contract )
Supplement CRC99-3
3P01HD035468 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2003    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: June 2003
Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
Pervasive Developmental Disorders
Secretin, synthetic porcine
Secretin, biological porcine
Autism Diagnostic Observation Schedule - Generic (ADOS-G)
Rimland Questionnaire
Expressive Vocabulary Test
MacArthur Communication Inventory
Aberrant Behavior Checklist
Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs