Dyad Oxytocin Study (DOS)

Phase 1

Completed

• Conditions: Schizophrenia; Autism Spectrum Disorder
• Interventions: Other: Placebo Comparator; Drug: Oxytocin

• Registration Number: NCT02302209
• Lead Sponsor: University of California, San Francisco

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2014-11-24
• Study First Submitted QC: 2014-11-25
• Study First Posted: 2014-11-26
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-17
• Last Update Posted: 2019-05-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo Comparator	Saline Nasal Spray
Oxytocin	Oxytocin	40 IU Oxytocin Intranasal

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States