Dyad Oxytocin Study (DOS) | NCT02302209

Studies
Dyad Oxytocin Study (DOS)

NCT02302209

Sponsor

University of California, San Francisco

Status

Completed

Last Update Posted

May 21, 2019Actual

Enrollment

104Actual

Phase

Phase 1

Conditions

Schizophrenia
Autism Spectrum Disorder

Interventions

Oxytocin
Placebo Comparator

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Nov 24, 2014

First Submission Date that Met QC Criteria

Nov 25, 2014

First Posted Date

Nov 26, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 17, 2019

Last Update Posted Date

May 21, 2019Actual

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

104Actual

Label	Type	Description	Intervention Names
Oxytocin	Experimental	40 IU Oxytocin Intranasal	Drug: Oxytocin
Placebo	Placebo Comparator	Saline Nasal Spray	Other: Placebo Comparator

Name	Type	Description	Arm Group Labels	Other Names
Oxytocin	Drug		Oxytocin	Syntocin
Placebo Comparator

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

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019967	Schizophrenia Spectrum and Other Psychotic Disorders
D001523	Mental Disorders
D002659	Child Development Disorders, Pervasive
D065886	Neurodevelopmental Disorders

ID	Term
D010909	Pituitary Hormones, Posterior
D010907	Pituitary Hormones
D036361	Peptide Hormones
D006728	Hormones

ID	Term
D012559	Schizophrenia
D000067877	Autism Spectrum Disorder