Clinical trial NCT02577575: Adult Oxytocin Study
Official title: The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Oxytocin
Social Cognition
Keywords: Oxytocin
Syntocinon
Social Cognition
Schizophrenia
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Veterans Affairs Medical Center
First posted: 2015-10-16
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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 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.


Eligibility 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

Primary outcomes:
measure: Improvement in social cognition task performance
timeFrame: 2-days at least 1-week apart
Secondary outcomes:
measure: Pre-morbid IQ Questionnaire (AmNART)
timeFrame: 1 day
measure: Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire
timeFrame: 1 day
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: 1 day
measure: Emotional Quotient Scale (EQS)
timeFrame: 1 day
measure: Kinsey Scale
timeFrame: 1 day
measure: Change in Working Memory capacity
timeFrame: 2-days at least 1-week apart
measure: Change in Auditory Perception correctness
timeFrame: 2-days at least 1-week apart
measure: Change in Auditory Perception reaction time
timeFrame: 2-days at least 1-week apart
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Veterans Affairs Medical Center
state: California
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California San Francisco, San Francisco Veterans Affairs Medical Center
name: Joshua D Woolley, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: