ASO-Behavioral: Adult Study Oxytocin - Behavioral

Sponsor

University of California, San Francisco (Other)

Overall Status

Completed

CT.gov ID

NCT02567032

Collaborator

San Francisco Veterans Affairs Medical Center (U.S. Fed)

324

Enrollment

Locations

Arms

106

Duration (Months)

162

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia Oxytocin Social Cognition Psychotic Disorders	Drug: Oxytocin Drug: Saline Nasal Spray	Early Phase 1

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

324 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - Behavioral

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Aug 1, 2019

Actual Study Completion Date :

Aug 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oxytocin 40 IU Oxytocin	Drug: Oxytocin 40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit. Other Names: Syntocinon
Placebo Comparator: Saline Nasal Spray Placebo Comparator	Drug: Saline Nasal Spray 40 IU of the saline nasal spray will be administered once at the beginning of the visit. Other Names: Placebo

Arm

Intervention/Treatment

Experimental: Oxytocin

40 IU Oxytocin

Drug: Oxytocin

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

Other Names:

Syntocinon

Placebo Comparator: Saline Nasal Spray

Placebo Comparator

Drug: Saline Nasal Spray

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

Other Names:

Placebo

Outcome Measures

Primary Outcome Measures

Change in Social Cognition Task Performance [Through study completion, 2-3 weeks]
Participants will undergo computer tasks that measure social cognition. Tasks will involve verbal responses, pressing buttons at specific times, listening, and viewing audio-visual stimuli. Investigators will be measuring the difference in accuracy and verbal content of the responses on the oxytocin day compared to the placebo day.

Secondary Outcome Measures

Physiological Measurements [Through study completion, 2-3 weeks]
Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks.
Questionnaire [At baseline visit, up to 4 hours]
Participants will be asked questions about their current positive and negative symptoms, medical and psychiatric history. Self-report responses will be saved in writing or audio recording.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco Veterans Affairs Medical Center	San Francisco	California	United States	94121
2	University of California, San Francisco	San Francisco	California	United States	94143