Dyad Oxytocin Study (DOS)

NCT02302209 | Completed Phase 1

• 1 other identifier: 10-04286
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Autism Spectrum Disorder

Keywords

oxytocin; schizophrenia; autism spectrum disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Oxytocin

EXPERIMENTAL

40 IU Oxytocin Intranasal

Drug: Oxytocin

Placebo

PLACEBO COMPARATOR

Saline Nasal Spray

Other: Placebo Comparator

Interventions

Oxytocin DRUG

Also known as: Syntocin

Oxytocin

Placebo Comparator OTHER

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Schizophrenia; Autism Spectrum Disorder

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Child Development Disorders, Pervasive; Neurodevelopmental Disorders

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Josh D Woolley, MD/PhD

  UC San Francisco and SFVAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in Residence

Study Record Dates

• First Submitted: November 24, 2014
• First Posted: November 26, 2014
• Study Start: April 1, 2011
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

US (1)