Dyad Oxytocin Study (DOS)

Study Overview
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Brief Summary
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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.

Official Title
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Effects of Oxytocin on Familial Interactions

Conditions
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Schizophrenia, Autism Spectrum Disorder

Intervention / Treatment
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* Drug: Oxytocin
* Other: Placebo Comparator


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxytocin<br>40 IU Oxytocin Intranasal | Drug: Oxytocin<br> <br> * Other names: Syntocin;|
| Placebo Comparator: Placebo<br>Saline Nasal Spray | Other: Placebo Comparator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Negative Expressed Emotion | We will measure the number of times caregivers show parental criticism, hostility, lack of warmth and emotional over-involvement. | Continuously for 4 hours after drug adimistration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oxytocin, schizophrenia, autism spectrum disorder