The Role of Vasopressin in the Social Deficits of Autism

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Stanford University
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01962870
First received: October 8, 2013
Last updated: March 5, 2014
Last verified: November 2013
  Purpose

Researchers at the Stanford University School of Medicine are seeking participants for a study examining the effectiveness of vasopressin, a neuropeptide, in treating children with autism spectrum disorder. Difficulty with social interactions is characteristic of people with autism, who often have problems interpreting facial expressions or maintaining eye contact while talking with someone. There are currently no effective medicines available to treat social problems in individuals with autism. Neuropeptides, such as vasopressin and oxytocin, are molecules used by neurons in the brain to communicate with one another. Vasopressin is closely related to oxytocin, which is currently being tested as a treatment for autism, and has been shown to enhance social functioning in animals. Animal studies have shown that when the proper functioning of vasopressin is experimentally altered, animals develop a variety of social deficits, including impaired memory for peers and a reduced interest in social interaction. Researchers found that when vasopressin was administered to mice with a genetically induced form of autism, their social functioning improved. Vasopressin is already approved by the Food and Drug Administration for use in humans, and has proved to be a successful treatment for some common pediatric conditions, including bedwetting. Similar to oxytocin, it also has been shown to improve social cognition and memory in people who do not have autism. The researchers will test the effects of vasopressin on social impairments in 50 boys and girls with autism, ages 6 to 12 years old. The study will last four weeks for each participant. Participants will receive either vasopressin or a placebo nasal spray. At the end of this phase of the study, those who received the placebo will have the option of participating in a four-week trial during which they will be given vasopressin. Stanford is the only site for the study. Participants do not need to live locally but will need to come to the Stanford University Department of Psychiatry and Behavioral Sciences for study visits.


Condition Intervention Phase
Autism Spectrum Disorders
Drug: Vasopressin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Randomized Placebo-controlled Trial of Vasopressin Treatment for Social Deficits in Children With Autism

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Change from baseline in parent rated Social Responsiveness Scale (SRS) scores during treatment. [ Time Frame: 4-week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline on the Dosage Record Treatment Emergent Symptom Scale (DOTES) scores during treatment. [ Time Frame: 30 minutes, 1-week, 2-week, 3-week, 4-week ] [ Designated as safety issue: Yes ]
  • Change from baseline in heart rate. [ Time Frame: 30 minutes, 1-week, 2-week, 3-week, 4-week ] [ Designated as safety issue: Yes ]
  • Change from baseline in Clinical Global Impression (CGI) scores during treatment. [ Time Frame: 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in parent rated Aberrant Behavior Checklist (ABC) scores during treatment. [ Time Frame: 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in parent rated Spence Children's Anxiety Scale (SCAS) during treatment. [ Time Frame: 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in parent rated Repetitive Behavior Scale Revised (RBS-R) scores during treatment. [ Time Frame: 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in parent rated Pediatric Quality of Life (PedQL) inventory scores during treatment. [ Time Frame: 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in Vineland Adaptive Behavior Scales Second Edition (VABS-II) - Social and Communication subscales. [ Time Frame: 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in laboratory based facial emotion recognition abilities during treatment. [ Time Frame: 30 minutes, 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in laboratory based eye-gaze to social cues during treatment. [ Time Frame: 30 minutes, 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in Reading the Mind in the Eyes Test, child version (RMET-child) scores during treatment. [ Time Frame: 30 minutes, 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in laboratory based social mimicry abilities during treatment. [ Time Frame: 30 minutes, 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in a Developmental Neuropsychological Assessment, Second Edition. (NEPSY-II) Social Perception and Memory for Faces & Names subscales scores during treatment. [ Time Frame: 30 minutes, 4-week ] [ Designated as safety issue: No ]
  • Change from baseline in plasma vasopressin levels during treatment. [ Time Frame: 4-week ] [ Designated as safety issue: Yes ]
  • Change from baseline in clinical chemistry labs (NA+, K+, Cl-, BUN). [ Time Frame: 1-week, 2-week, 4-week ] [ Designated as safety issue: Yes ]
  • Change from baseline in the Awareness of Social Inference Test Revised (TASIT-R) scores during treatment. [ Time Frame: 30 minutes, 4-week ] [ Designated as safety issue: No ]
  • Change from baseline on the Overt Aggression Scale (OAS) during treatment. [ Time Frame: 30 minutes, 1-week, 2-week, 3-week, 4-week ] [ Designated as safety issue: Yes ]
  • Change from baseline in blood pressure. [ Time Frame: 30 minutes, 1-week, 2-week, 3-week, 4-week ] [ Designated as safety issue: Yes ]
  • Change from baseline in body temperature. [ Time Frame: 30 minutes, 1-week, 2-week, 3-week, 4-week ] [ Designated as safety issue: Yes ]
  • Change from baseline in body mass index. [ Time Frame: 1-week, 2-week, 3-week, 4-week ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: October 2013
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo Nasal Spray
Drug: Placebo
Active Comparator: Vasopressin
Vasopressin Nasal Spray
Drug: Vasopressin
Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).

  Eligibility

Ages Eligible for Study:   6 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • medically healthy outpatients between 6 and 12 years of age (cut off: 12 years and 11 months)
  • Intelligence Quotient (IQ) equal to or greater than 70 (Stanford-Binet)
  • Social Responsiveness Scale (SRS) Total Score equal to or greater than 70
  • ability to complete laboratory and cognitive testing
  • diagnosis of Autism Spectrum Disorder (ASD) based on expert clinical opinion and on the Autism Diagnostic Interview-Revised (ADI-R), Autism Diagnostic Observation Schedule (ADOS)
  • Clinical Global Impression (CGI) severity rating of 4 or higher
  • care provider who can reliably bring participant to clinic visits, provide trustworthy ratings, and interact with the participant on a regular basis
  • stable medications for at least 4 weeks
  • no planned changes in psychosocial interventions during the trial
  • no concurrent participation in any other clinical research trials
  • willingness to provide blood samples

Exclusion Criteria:

  • diagnosis of schizophrenia, schizoaffective disorder, bipolar disorder, or psychotic disorder
  • regular nasal obstruction or nosebleeds
  • active and unstable medical problems (e.g., migraine; asthma; seizure disorder; anaphylaxis; epilepsy; diabetes; serious liver, renal, or cardiac pathology)
  • clinically significant abnormal vital signs or ECG reading
  • evidence of a genetic (e.g., Fragile X Syndrome) or metabolic disorder
  • significant hearing or vision impairments
  • drinks large volumes of water (e.g., habitual or psychogenic polydipsia)
  • pregnant or sexually active females not using a reliable method of contraception (urine pregnancy test will be conducted)
  • history of hypersensitivity to vasopressin, its analogs (e.g., Desmopressin), or compounding preservatives (e.g., chlorobutanol)
  • current use of any medications known to interact with vasopressin including: 1) carbamazepine (i.e., Tegretol); chlorpropamide; clofibrate; urea; fludrocortisone; tricyclic antidepressants (all of which may potentiate the antidiuretic effect of vasopressin when used concurrently); 2) demeclocycline; norepinephrine; lithium; heparin; alcohol (all of which may decrease the antidiuretic effect of vasopressin when used concurrently); 3) ganglionic blocking agents including benzohexonium, chlorisondamine, pentamine (all of which may produce a marked increase in sensitivity to the pressor effects of vasopressin)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01962870

Contacts
Contact: Robin A Libove, BS (650) 736-1235 rlibove@stanford.edu
Contact: Dean S Carson, PhD (650) 736-1235 dcarson@stanford.edu

Locations
United States, California
Stanford University School of Medicine; Psychiatry and Behavioral Sciences Recruiting
Stanford, California, United States, 94305
Contact: Robin A Libove, BS    650-736-1235    rlibove@stanford.edu   
Contact: Dean S Carson, PhD    (650) 736-1235    dcarson@stanford.edu   
Sub-Investigator: Dean S Carson, PhD         
Principal Investigator: Antonio Y Hardan, MD         
Principal Investigator: Karen J Parker, PhD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Antonio Y Hardan, MD Stanford University
Principal Investigator: Karen J Parker, PhD Stanford University
Study Director: Dean S Carson, PhD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01962870     History of Changes
Other Study ID Numbers: IRB26034
Study First Received: October 8, 2013
Last Updated: March 5, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014