Dyad Oxytocin Study (DOS)

Effects of Oxytocin on Familial Interactions

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02302209

Acronym

DOS

Enrollment

104

Registered

2014-11-26

Start date

2011-04-30

Completion date

2017-10-31

Last updated

2019-05-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autism Spectrum Disorder, Schizophrenia

Keywords

oxytocin, schizophrenia, autism spectrum disorder

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.

Interventions

DRUGOxytocin

OTHERPlacebo Comparator

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

OTHER

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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).

Design outcomes

Primary

Measure	Time frame	Description
Change in Negative Expressed Emotion	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026