Dyad Oxytocin Study (DOS)

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.

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Key information

Conditions

Schizophrenia Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders Schizophrenia Spectrum and Other Psychotic Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of California, San Francisco

San Francisco, California, 94143, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

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

Treatment and study plan

Oxytocin

Drug

Other names: Syntocin

Placebo Comparator

Other

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Effects of Oxytocin on Familial Interactions

Acronym: DOS

Important dates

Study start: 2011
Primary completion: 2017
Study completion: 2017
First posted: Nov 26, 2014
Registry last updated: May 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed