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Dyad Oxytocin Study (DOS) (DOS)

Primary Purpose

Schizophrenia, Autism Spectrum Disorder

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Oxytocin
Placebo Comparator
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Schizophrenia focused on measuring oxytocin, schizophrenia, autism spectrum disorder

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Oxytocin

Placebo

Arm Description

40 IU Oxytocin Intranasal

Saline Nasal Spray

Outcomes

Primary Outcome Measures

Change in Negative Expressed Emotion
We will measure the number of times caregivers show parental criticism, hostility, lack of warmth and emotional over-involvement.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2014
Last Updated
May 17, 2019
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02302209
Brief Title
Dyad Oxytocin Study (DOS)
Acronym
DOS
Official Title
Effects of Oxytocin on Familial Interactions
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Autism Spectrum Disorder
Keywords
oxytocin, schizophrenia, autism spectrum disorder

7. Study Design

Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oxytocin
Arm Type
Experimental
Arm Description
40 IU Oxytocin Intranasal
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Saline Nasal Spray
Intervention Type
Drug
Intervention Name(s)
Oxytocin
Other Intervention Name(s)
Syntocin
Intervention Type
Other
Intervention Name(s)
Placebo Comparator
Primary Outcome Measure Information:
Title
Change in Negative Expressed Emotion
Description
We will measure the number of times caregivers show parental criticism, hostility, lack of warmth and emotional over-involvement.
Time Frame
Continuously for 4 hours after drug adimistration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Josh D Woolley, MD/PhD
Organizational Affiliation
UC San Francisco and SFVAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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Dyad Oxytocin Study (DOS)

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