Dyad Oxytocin Study (DOS)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2017-10-31

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.

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Detailed Description

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Conditions

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Schizophrenia Autism Spectrum Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Oxytocin

40 IU Oxytocin Intranasal

Group Type EXPERIMENTAL

Oxytocin

Intervention Type DRUG

Placebo

Saline Nasal Spray

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type OTHER

Interventions

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Oxytocin

Intervention Type DRUG

Placebo Comparator

Intervention Type OTHER

Other Intervention Names

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Syntocin

Eligibility Criteria

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Inclusion Criteria

* 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

* 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
* Between the ages of 14 and 45
* Healthy control must have a primary caregiver
* 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

* 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
* Healthy controls with history of psychiatric or neurological illness
* Patients with an Intelligence Quotient (IQ) lower than 75
* Patients with severe brain trauma

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes