Clinical trial NCT02302209: Dyad Oxytocin Study (DOS)
Official title: Effects of Oxytocin on Familial Interactions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schizophrenia
Autism Spectrum Disorder
Keywords: oxytocin
schizophrenia
autism spectrum disorder
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-11-26
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in Negative Expressed Emotion
timeFrame: Continuously for 4 hours after drug adimistration
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: UC San Francisco and SFVAMC
name: Josh D Woolley, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: