Status:

COMPLETED

Dyad Oxytocin Study (DOS)

Lead Sponsor:

University of California, San Francisco

Conditions:

Schizophrenia

Autism Spectrum Disorder

Eligibility:

All Genders

18-75 years

Phase:

PHASE1

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...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

April 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 1 2017

Estimated Enrollment :

104 Patients enrolled

Trial Details

Trial ID

NCT02302209

Start Date

April 1 2011

End Date

October 1 2017

Last Update

May 21 2019

Active Locations (1)

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1

University of California, San Francisco

San Francisco, California, United States, 94143