Adult Study Oxytocin - fMRI

NCT ID: NCT02566356

Last Updated: 2019-05-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 59 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2017-09-30

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Oxytocin

40 IU Oxytocin

Group Type: EXPERIMENTAL

Oxytocin

Intervention Type: DRUG

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

Saline Nasal Spray

Placebo Comparator

Group Type: PLACEBO_COMPARATOR

Saline Nasal Spray

Intervention Type: DRUG

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Interventions

Oxytocin

40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.

Intervention Type: DRUG

Saline Nasal Spray

40 IU of the saline nasal spray will be administered once at the beginning of the visit.

Intervention Type: DRUG

Other Intervention Names

Syntocinon; Placebo

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

San Francisco Veterans Affairs Medical Center

FED

Sponsor Role: collaborator

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Joshua Woolley

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josh D Woolley, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

University of California San Francisco, San Francisco Veterans Affairs Medical Center

Locations

San Francisco Veterans Affairs Medical Center

San Francisco, California, United States

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

12-09654

Identifier Type: -

Identifier Source: org_study_id