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Oxytocin MEG Study (MEG)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568709
Recruitment Status : Completed
First Posted : October 6, 2015
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 29, 2015
First Posted Date  ICMJE October 6, 2015
Last Update Posted Date May 21, 2019
Study Start Date  ICMJE February 2012
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
Change in MEG neural activation patterns [ Time Frame: Oxytocin and placebo administration days at least 1-week apart ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 5, 2015)
  • Change in performance on Facial Recognition Task [ Time Frame: Oxytocin and placebo administration days at least 1-week apart ]
    In the Facial Recognition Task, subjects will be presented with various computerized emotional stimuli and will be asked to make a choice. Participants will then respond to the stimuli by pressing a either left or right on the control box and their reaction time will be measured.
  • Change in performance on International Affective Picture System (IAPS) task [ Time Frame: Oxytocin and placebo administration days at least 1-week apart ]
    In the IAPS Tasks, subjects will view images of people, objects, and scenes from the IAPS (International Affective Picture System). Participants will then respond by pressing a either left or right on the control box to chose a number from 1 (i.e. least disturbing) to 9 (i.e. most disturbing) and their reaction time will be measured.
  • UCLA Loneliness Scale [ Time Frame: 1 day ]
    The UCLA Loneliness Scale assesses the loneliness level of participants. It is a 20-item scale where responses are measured from O ("I often feel this way") to N ("I never feel this way").
  • Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire [ Time Frame: 1 day ]
    The ECR is used to evaluate the construct of adult attachment. The scale involves 36 itemized statements split into four parts, each part referring to a different attachment figure. Participants rank each item using a 7-point likert scale.
  • Childhood Trauma Questionnaire (CTQ) [ Time Frame: 1 day ]
    The CTQ is a brief survey of 6 early traumatic experiences, including death, divorce, violence, sexual abuse, illness or other. The scale determines and assesses an individual's understanding of their childhood trauma, if applicable.
  • Parental Bonding Instrument (PBI) [ Time Frame: 1 day ]
    The PBI measures fundamental parenting styles as perceived the child. The questionnaire is retrospective in that it asks the adult participant to answer the questions based on how they remember their parents to be during up until they were 16 years old. The measure is completed for both mothers and fathers separately. There are 25 questions where half the questions are focused on how the parent cared for them and half are focused on how the parents protected them. A likert scale is used to measure responses where 1 is agree (i.e. very like) and 4 is disagree (i.e. very dislike).
  • Emotional Quotient Scale (EQS) [ Time Frame: 1 day ]
    The EQ is a 60-item self-report questionnaire that is designed to measure empathy in adults. Participants use a 4 item likert scale to record their responses (1=definitely agree, 4= definitely disagree).
  • Fagerstom Nicotine Dependence Test [ Time Frame: 1 day ]
    The FNDT is the standard measure of an individual's physical addiction to nicotine. The test contains six items to evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.
  • Quality of Life Scale (QLS) [ Time Frame: 1 day ]
    The QLS is a 21-item clinical rating scale where the interviewer rates the participant's responses on a scale of 1-6 where 6 indicates no impairment. In this study, an abbreviated version of the QLS is used that includes 9 of the 21 items. The 9 items are each derived from the sections examining interpersonal relations, occupational role functioning, intrapsychic foundations, and common objects.
  • Social Functioning Scale (SFS) [ Time Frame: 1 day ]
    The SFS is designed to assess a subject's social skills and performance, and to measure functions that are of importance for schizophrenic patients. It is a 79-item scale completed by the subject.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oxytocin MEG Study
Official Title  ICMJE Effects of Oxytocin on Neural Activation Patterns During Social Cognitive Tasks in Patients With Schizophrenia
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. understand the pathophysiology of the functionally debilitating social cognitive deficits of schizophrenia,
  2. test the efficacy of OT in normalizing the neural abnormalities underlying these social deficits, and
  3. develop and optimize novel treatments for these currently untreatable deficits.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Schizophrenia
  • Oxytocin
  • Magnetoencephalography (MEG)
  • Social Cognition
Intervention  ICMJE
  • Drug: Oxytocin
    40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
    Other Name: Syntocinon
  • Drug: Saline Nasal Spray
    40 IU of the saline nasal spray will be administered once at the beginning of the visit.
    Other Name: Placebo
Study Arms  ICMJE
  • Active Comparator: Interventional
    40 IU Oxytocin
    Intervention: Drug: Oxytocin
  • Placebo Comparator: Saline Nasal Spray
    Placebo Comparator
    Intervention: Drug: Saline Nasal Spray
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2016)
40
Original Estimated Enrollment  ICMJE
 (submitted: October 5, 2015)
50
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date December 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Patients:

  • 18-40 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

Inclusion Criteria for Healthy Controls:

  • 18-40 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

Exclusion Criteria:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02568709
Other Study ID Numbers  ICMJE 12-08411
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joshua Woolley, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Josh D Woolley, MD/PhD University of California San Francisco, San Francisco Veterans Affairs Medical Center
PRS Account University of California, San Francisco
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP