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Adult Study Oxytocin - fMRI (ASO-fMRI)

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ClinicalTrials.gov Identifier: NCT02566356
Recruitment Status : Completed
First Posted : October 2, 2015
Last Update Posted : May 21, 2019
Sponsor:
Collaborator:
San Francisco Veterans Affairs Medical Center
Information provided by (Responsible Party):
Joshua Woolley, University of California, San Francisco

Tracking Information
First Submitted Date  ICMJE September 30, 2015
First Posted Date  ICMJE October 2, 2015
Last Update Posted Date May 21, 2019
Study Start Date  ICMJE September 2012
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
Change in fMRI neural activation patterns [ Time Frame: 2-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 medial prefrontal cortex and the temporoparietal junction between placebo and oxytocin testing days using the fMRI 3T Siemens Skyra scanner.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02566356 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 30, 2015)
  • 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 the fMRI 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.
  • 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) [ 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.
  • 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).
  • Premorbid IQ test (AmNART) [ Time Frame: 1 day ]
    The American National Adult Reading Test (AMNART) is an instrument used to estimate premorbid verbal IQ in adults. Participants are shown 45 words one at a time and are asked to read the word aloud. The scorer then writes 0 if the participant read the word incorrectly or 1 if the pronunciation is correct.
  • 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.
  • 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).
  • Kinsey Scale [ Time Frame: 1 day ]
    The Kinsey scale attempts to describe a person's sexual orientation using a scale from 0 (i.e. heterosexual) to 6 (i.e. homosexual).
  • Socioeconomic Status (SES) [ Time Frame: 1 day ]
    This assess participants' socioeconomic status through their educational level and occupational level using a scale from 1 (i.e. professional, higher executive level) to 7 (i.e. less than 7 years of school, unskilled employee). This scale is also used for the participants' primary and secondary caretakers.
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 Adult Study Oxytocin - fMRI
Official Title  ICMJE Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - fMRI
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 examine the effects of exogenous oxytocin on patterns of neural activation as measured by fMRI during a well-characterized affect-labeling task in patients with recent-onset schizophrenia and healthy comparison subjects.

Hypothesis A: Patients will exhibit amygdalar hyperactivity and PNS hypo-activity when passively viewing faces, which will be normalized by administration of oxytocin.

Hypothesis B: Patients will exhibit hypo-activity of the vPFC when affectively labeling faces and this hypo-activity will be normalized by oxytocin administration.

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
  • Social Cognition
  • Functional Magnetic Resonance Imaging (fMRI)
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
  • Experimental: Oxytocin
    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 22, 2019)
59
Original Estimated Enrollment  ICMJE
 (submitted: September 30, 2015)
72
Actual Study Completion Date  ICMJE September 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria for Patients:

  • Male
  • SCID-IV confirmed diagnosis of schizophrenia or schizoaffective disorder
  • Clinically stable
  • No changes to medications for the past week

Inclusion Criteria for Healthy Controls:

  • Male
  • SCID-IV confirmed no diagnosis of a current Axis I disorder within the last year

Exclusion Criteria for Patients and Healthy Controls:

  • Meeting criteria for current substance abuse or dependence or illicit drug use within the last month (nicotine use is acceptable) as determined by a Urine Toxicology Drug Screening
  • Any illness that affects the nasal passages and impairs the delivery of a nasal spray
  • Presence of any neurological or significant medical disorder, including medical illnesses that could interfere with physiological recording such as cardiac arrhythmias
  • A pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos
  • Pregnancy
  • Claustrophpbia
  • Hearing difficulties
  • A history of seizures
  • Failure to receive a passing score on the reading test

Additional Exclusion Criteria for Patients and Healthy Controls:

  • Taking any psychotropic medication or any medication that affects the autonomic or cardiovascular systems.
  • Schizophrenia or other psychotic disorder in a first degree relative
  • Failure to receive a passing score on the MOCA
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 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 NCT02566356
Other Study ID Numbers  ICMJE 12-09654
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 San Francisco Veterans Affairs Medical Center
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