Clinical trial NCT02567032: Adult Study Oxytocin - Behavioral
Official title: Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Schizophrenia
Oxytocin
Social Cognition
Psychotic Disorders
Keywords: Oxytocin
Syntocinon
Social Cognition
Schizophrenia
Psychosis
Schizoaffective Disorder
Schizophreniform Disorder
Psychotic Disorders
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: San Francisco Veterans Affairs Medical Center
First posted: 2015-10-02
Enrollment: 324
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: 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 and other psychotic disorders. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders.

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.

Detailed description: Part 2: A supplementary study will be added to the proposed parent study, which includes additional behavioral testing consisting of several social cognition computer tasks, clinical assessments, physiological measurements, and questionnaires. The study will be conducted with the same study arms and study interventions as in the proposed parent study. For this supplementary study, the inclusion criteria has broadened to include patients with bipolar disorder with psychotic features and brief psychotic disorder.

Eligibility criteria: Inclusion Criteria for Patients:

* 18 to 45 years of age
* Clinically stable
* English Speaking
* Meet DSM-5 criteria for schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder with psychotic features, or brief psychotic 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 45 years of age
* Clinically stable
* English Speaking
* No diagnosis of mental disorder according to DSM-5, not including mild alcohol use disorder or mild cannabis use disorder
* Able to use nasal spray
* Must be capable of providing informed consent

Exclusion Criteria for Patients:

* Active substance and alcohol use disorder in the past month as determined by the DSM-5 criteria, not including cannabis use disorder
* Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
* Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
* Hearing deficits
* Pregnancy
* Severe brain trauma

Exclusion Criteria for Healthy Controls:

* Active substance and moderate/severe alcohol use disorder, or mood disorder in the past month as determined by the DSM-5 criteria, not including mild alcohol use disorder or mild cannabis use disorder
* Meet for a current psychiatric disorder according to DSM-5 criteria
* Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
* Medical conditions like 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: Change in Social Cognition Task Performance
timeFrame: Through study completion, 2-3 weeks
Secondary outcomes:
measure: Physiological Measurements
timeFrame: Through study completion, 2-3 weeks
measure: Questionnaire
timeFrame: At baseline visit, up to 4 hours
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: Josh D Woolley, MD/PhD
role: PRINCIPAL_INVESTIGATOR
References: