Adult Oxytocin Study

NCT02577575 | Completed Early Phase 1 DMC

• 1 other identifier: 10-01508
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia. Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia. Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo. Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo. Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (PNS) activity in patients with recent-onset schizophrenia. Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS activity during social tasks after administration of oxytocin versus placebo. Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their PNS activity.

Conditions

Schizophrenia; Oxytocin; Social Cognition

Keywords

Oxytocin; Syntocinon; Social Cognition; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Improvement in social cognition task performance

  The outcome will be the number of tasks that improve on the oxytocin day compared to the placebo day in a panel of tasks designed to measure the subject's level of social cognition. Participants will complete social cognition tasks, which include the Auction Task, Devil's Task, Ultimatum Task, Verbal Prosody, Effort Expenditure for Rewards Task (EEfRT), and Passive Viewing Eyetracking.

  2-days at least 1-week apart

Secondary Outcomes (8)

• Pre-morbid IQ Questionnaire (AmNART)

  1 day

• Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire

  1 day

• Childhood Trauma Questionnaire (CTQ)

  1 day

• Emotional Quotient Scale (EQS)

  1 day

• Kinsey Scale

  1 day

Study Arms (2)

Oxytocin

EXPERIMENTAL

40 IU Oxytocin

Drug: Oxytocin

Saline Nasal Spray

PLACEBO COMPARATOR

Placebo Comparator

Drug: Saline Nasal Spray

Interventions

Oxytocin DRUG

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

Also known as: Syntocinon

Oxytocin

Saline Nasal Spray DRUG

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Also known as: Placebo

Saline Nasal Spray

Eligibility Criteria

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

You may qualify if:

• to 65 years of age
• English Speaking
• Meet Diagnostic and Statistical Manual (DSM)-IV criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder.
• No or at most only minor changes to medications in the past week
• Able to use nasal spray
• Must be capable of providing informed consent
• to 65 years of age
• Clinically stable
• No diagnosis of mental disorder according to DSM-IV TR.
• Able to use nasal spray
• Must be capable of providing informed consent
• English Speaking

You may not qualify if:

• Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
• A current DSM-IV diagnosis of any disorder other than schizophrenia
• Medical conditions (atrophic rhinitis, recurrent nose bleeds and cranial-surgical procedures (hypophysectomy), congestion or sinus problems) that could interfere with the study as per the opinion of the investigator
• Hearing deficits
• Pregnancy
• Severe brain trauma

Sponsors & Collaborators

• University of California, San Francisco: lead
• San Francisco Veterans Affairs Medical Center: collaborator

Study Sites (2)

San Francisco Veterans Affairs Medical Center

San Francisco, California, 94121, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

MeSH Terms

Conditions

Schizophrenia

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental 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

• Joshua D Woolley, MD/PhD

  University of California San Francisco, San Francisco Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 29, 2015
• First Posted: October 16, 2015
• Study Start: August 1, 2010
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

US (2)