Adult Study Oxytocin - fMRI

NCT02566356 | Completed Early Phase 1 DMC

• 1 other identifier: 12-09654
• Study Type: interventional
• Target: 59
• 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 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.

Conditions

Schizophrenia; Oxytocin; Social Cognition; Functional Magnetic Resonance Imaging (fMRI)

Keywords

Oxytocin; Syntocinon; Social Cognition; Schizophrenia; Functional Magnetic Resonance Imaging (fMRI)

Outcome Measures

Primary Outcomes (1)

• Change in fMRI neural activation patterns

  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.

  2-days at least 1-week apart

Secondary Outcomes (10)

• Quality of Life Scale (QLS)

  1 day

• Social Functioning Scale (SFS)

  1 day

• UCLA Loneliness Scale

  1 day

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

  1 day

• Parental Bonding Instrument (PBI)

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

You may qualify if:

• Male
• SCID-IV confirmed diagnosis of schizophrenia or schizoaffective disorder
• Clinically stable
• No changes to medications for the past week
• Male
• SCID-IV confirmed no diagnosis of a current Axis I disorder within the last year

You may not qualify if:

• 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
• 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

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

• 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 30, 2015
• First Posted: October 2, 2015
• Study Start: September 1, 2012
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: May 21, 2019

Record last verified: 2019-05

Locations

US (2)