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Dyad Oxytocin Study (DOS) (DOS)

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ClinicalTrials.gov Identifier: NCT02302209
Recruitment Status : Completed
First Posted : November 26, 2014
Last Update Posted : December 5, 2018
Sponsor:
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco

Brief Summary:
The purpose of the investigators proposed study is twofold: 1) To investigate the role of the affiliative neuropeptide oxytocin in unhealthy interactions in families of patients with schizophrenia and families of patients with autism spectrum disorder, and 2) to investigate whether manipulation of this oxytocinergic system positively influences these family interactions.

Condition or disease Intervention/treatment Phase
Schizophrenia Autism Spectrum Disorder Drug: Oxytocin Other: Placebo Comparator Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Effects of Oxytocin on Familial Interactions
Study Start Date : April 2011
Actual Primary Completion Date : October 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Oxytocin

Arm Intervention/treatment
Experimental: Oxytocin
40 IU Oxytocin Intranasal
Drug: Oxytocin
Other Name: Syntocin

Placebo Comparator: Placebo
Saline Nasal Spray
Other: Placebo Comparator



Primary Outcome Measures :
  1. Change in Negative Expressed Emotion [ Time Frame: Continuously for 4 hours after drug adimistration ]
    We will measure the number of times caregivers show parental criticism, hostility, lack of warmth and emotional over-involvement.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Inclusion criteria for caregiver of patients with schizophrenia, patients with autism spectrum disorder, and healthy controls:
  • Age between 18 and 75 years old
  • Must have at least 4 hours of contact with the patient per week and be considered a "significant caregiver" by the patient

Inclusion criteria for patients with schizophrenia:

  • Between the ages of 14 and 45.
  • Patients must have a diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychosis- Not Otherwise Specified (NOS).
  • Patients must be clinically stable
  • No or minor changes to medications in the past week
  • Patients must have a primary caregiver
  • Inclusion criteria for healthy control child:
  • Between the ages of 14 and 45
  • Healthy control must have a primary caregiver
  • Inclusion criteria for patients with autism spectrum disorder
  • Between the ages of 14 and 45
  • Patient must have a primary caregiver
  • Patients must have a diagnosis of an autism spectrum disorder (ASD) (autism or Asperger's disorder), pervasive developmental disorder (PDD) or pervasive developmental disorder - not otherwise specified (PDD-NOS).

Exclusion Criteria:

Exclusion criteria for all caregivers:

  • Female caregivers that state that they are pregnant or have a positive urine pregnancy test
  • Caregivers who have significant nasal pathology, atrophic rhinitis, recurrent nose bleeds, or history of cranial-surgical procedures (hypophysectomy)
  • Caregivers with significant psychiatric, neurologic, or medical illness
  • Exclusion criteria for healthy controls:
  • Healthy controls with history of psychiatric or neurological illness
  • Exclusion criteria for patients with an autism spectrum disorder:
  • Patients with an Intelligence Quotient (IQ) lower than 75
  • Exclusion criteria for patients with schizophrenia
  • Patients with severe brain trauma

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 ClinicalTrials.gov identifier (NCT number): NCT02302209


Locations
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United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
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Principal Investigator: Josh D Woolley, MD/PhD UC San Francisco and SFVAMC

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Responsible Party: Joshua Woolley, Assistant Professor in Residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02302209     History of Changes
Other Study ID Numbers: 10-04286
First Posted: November 26, 2014    Key Record Dates
Last Update Posted: December 5, 2018
Last Verified: December 2018

Keywords provided by Joshua Woolley, University of California, San Francisco:
oxytocin
schizophrenia
autism spectrum disorder

Additional relevant MeSH terms:
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Schizophrenia
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Neurodevelopmental Disorders
Oxytocin
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs