Oxytocin MEG Study

University of California San Francisco (UCSF)

Status and phase: Completed; Early Phase 1

Conditions: Magnetoencephalography (MEG); Schizophrenia; Oxytocin; Social Cognition

Treatments: Drug: Oxytocin; Drug: Saline Nasal Spray

Study type: Interventional

Funder types: Other

Identifiers

NCT02568709

12-08411

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

Interventional

Active Comparator group

Description:

40 IU Oxytocin

Treatment:

Drug: Oxytocin

Saline Nasal Spray

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Drug: Saline Nasal Spray