Dyad Oxytocin Study (DOS)

Completed · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia, Autism Spectrum Disorder

In brief

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.

Key facts

Study ID

NCT02302209

Run by

University of California, San Francisco

People needed

104

Starts

2011-04-01

Expected to finish

2017-10-01

Last updated by the study team

2019-05-21

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• University of California, San Francisco — San Francisco, California, United States

Full record on ClinicalTrials.gov

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