Oxytocin MEG Study

NCT02568709 | Completed Early Phase 1 DMC

• 1 other identifier: 12-08411
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The specific aim of this proposal is to investigate the neurophysiological mechanisms of oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using magnetoencephalography. Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will be normalized. Hypothesis B: When OT is administered to patients with schizophrenia, the decreased functional connectivity (FC) between the amygdala, FG, and ACC will be normalized. By elucidating the neurophysiological mechanisms of OT administration on emotional face processing, investigators will bee able to:

1. 1.understand the pathophysiology of the functionally debilitating social cognitive deficits of schizophrenia,
2. 2.test the efficacy of OT in normalizing the neural abnormalities underlying these social deficits, and
3. 3.develop and optimize novel treatments for these currently untreatable deficits.

Conditions

Schizophrenia; Oxytocin; Magnetoencephalography (MEG); Social Cognition

Keywords

Oxytocin; Syntocinon; Social Cognition; Schizophrenia; Magnetoencephalography (MEG)

Outcome Measures

Primary Outcomes (1)

• Change in MEG neural activation patterns

  During tasks in which participants will see and hear various stimuli, investigators will measure the change in neural activity in the amygdala, the dorsal anterior cingulate cortex, as well as the fusiform gyrus using the MEG scanner.

  Oxytocin and placebo administration days at least 1-week apart

Secondary Outcomes (10)

• Change in performance on Facial Recognition Task

  Oxytocin and placebo administration days at least 1-week apart

• Change in performance on International Affective Picture System (IAPS) task

  Oxytocin and placebo administration days at least 1-week apart

• UCLA Loneliness Scale

  1 day

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

  1 day

• Childhood Trauma Questionnaire (CTQ)

  1 day

Study Arms (2)

Interventional

ACTIVE COMPARATOR

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

Interventional

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 - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• Male
• Must comprehend English
• Meet DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder
• None or only minor changes to medications in the past week
• Able to use nasal spray
• Must be capable of providing informed consent
• Clinically stable
• years of age
• Male
• Must comprehend English
• No diagnosis of mental disorder according to DSM-IV TR
• Able to use nasal spray
• Must be capable of providing informed consent
• Clinically stable

You may not qualify if:

• Female
• Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
• 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
• A pacemaker, extensive dental work, or any magnetic metal implants
• Any history of 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

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

• Josh 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 6, 2015
• Study Start: February 1, 2012
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

US (1)