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