Adult Oxytocin Study (OT)

University of California San Francisco (UCSF)

Status and phase: Completed; Early Phase 1

Conditions: Schizophrenia; Oxytocin; Social Cognition

Treatments: Drug: Oxytocin; Drug: Saline Nasal Spray

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT02577575

10-01508

Details and patient eligibility

About

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 quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.

Hypothesis A: Patients and healthy comparison subjects will show enhanced social cognition (e.g., improved interpretation of paralinguistic and emotional cues, such as those involved in emotional or sarcastic communication) after administration of oxytocin versus placebo.

Hypothesis B: Patients and healthy comparison subjects will show increased attention to others' eyes and patients will exhibit increased facial affect expressivity after administration of oxytocin versus placebo.

Aim 2: To examine the effects of exogenous oxytocin on persistent negative symptoms in schizophrenia (PNS) activity in patients with recent-onset schizophrenia.

Hypothesis A: Patients and healthy comparison subjects will demonstrate increased PNS activity during social tasks after administration of oxytocin versus placebo.

Hypothesis B (exploratory): Patients and healthy comparison subjects' improvements in social cognition and behavior will be predicted by the degree to which oxytocin increases their PNS activity.

Enrollment: 120 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Patients:

• 18 to 65 years of age
• English Speaking
• Meet Diagnostic and Statistical Manual (DSM)-IV criteria for schizophrenia, schizoaffective disorder, schizophreniform disorder.
• No or at most only minor changes to medications in the past week
• Able to use nasal spray
• Must be capable of providing informed consent

Inclusion Criteria for healthy volunteers:

• 18 to 65 years of age
• Clinically stable
• No diagnosis of mental disorder according to DSM-IV TR.
• Able to use nasal spray
• Must be capable of providing informed consent
• English Speaking

Exclusion Criteria:

• Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
• A current 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
• Pregnancy
• Severe brain trauma

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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120 participants in 2 patient groups, including a placebo group

Oxytocin

Experimental group

Description:

40 IU Oxytocin

Treatment:

Drug: Oxytocin

Saline Nasal Spray

Placebo Comparator group

Description:

Placebo Comparator

Treatment:

Drug: Saline Nasal Spray