Dyad Oxytocin Study (DOS)

University of California San Francisco (UCSF)

Status and phase

Completed

Phase 1

Conditions

Autism Spectrum Disorder

Schizophrenia

Treatments

Other: Placebo Comparator

Drug: Oxytocin

Study type

Interventional

Funder types

Other

Identifiers

NCT02302209

10-04286

Details and patient eligibility

About

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.

Enrollment

104 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

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