Dyad Oxytocin Study (DOS) (DOS)

May 17, 2019 updated by: Joshua Woolley, University of California, San Francisco

Effects of Oxytocin on Familial Interactions

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Oxytocin
40 IU Oxytocin Intranasal
Drug: Oxytocin
Other Names:
  • Syntocin
Placebo Comparator: Placebo
Saline Nasal Spray
Other: Placebo Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Continuously for 4 hours after drug adimistration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Josh D Woolley, MD/PhD, UC San Francisco and SFVAMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

October 1, 2017

Study Registration Dates

First Submitted

November 24, 2014

First Submitted That Met QC Criteria

November 25, 2014

First Posted (Estimate)

November 26, 2014

Study Record Updates

Last Update Posted (Actual)

May 21, 2019

Last Update Submitted That Met QC Criteria

May 17, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-04286

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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