Dyad Oxytocin Study (DOS)

Schizophrenia Clinical Trial

— DOS  

Official title:

Effects of Oxytocin on Familial Interactions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02302209
• Other study ID #: 10-04286
• Status: Completed
• Phase: Phase 1
• Start date: April 2011
• Est. completion date: October 2017

Study information

• Verified date: May 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: October 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Child Development Disorders, Pervasive
• Schizophrenia

Intervention

Drug:
• Oxytocin

Other:
• Placebo Comparator

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Negative Expressed Emotion	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