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Clinical Trials/NCT02566356
NCT02566356
Completed
Early Phase 1

Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - fMRI

University of California, San Francisco2 sites in 1 country59 target enrollmentSeptember 2012

Overview

Phase
Early Phase 1
Intervention
Oxytocin
Conditions
Schizophrenia
Sponsor
University of California, San Francisco
Enrollment
59
Locations
2
Primary Endpoint
Change in fMRI neural activation patterns
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
September 2017
Last Updated
6 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Male

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Joshua Woolley

Principal Investigator

University of California, San Francisco

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Oxytocin

40 IU Oxytocin

Intervention: Oxytocin

Saline Nasal Spray

Placebo Comparator

Intervention: Saline Nasal Spray

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Parental Bonding Instrument (PBI)(1 day)
  • Social Functioning Scale (SFS)(1 day)
  • Premorbid IQ test (AmNART)(1 day)
  • UCLA Loneliness Scale(1 day)
  • Experiences in Close Relationships - Relationship Structures (ECR-RS)(1 day)
  • Socioeconomic Status (SES)(1 day)
  • Emotional Quotient Scale (EQS)(1 day)
  • Quality of Life Scale (QLS)(1 day)
  • Kinsey Scale(1 day)
  • Childhood Trauma Questionnaire (CTQ)(1 day)

Study Sites (2)

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