- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02577575
Adult Oxytocin Study (OT)
The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
California
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San Francisco, California, United States, 94143
- University of California, San Francisco
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San Francisco, California, United States, 94121
- San Francisco Veterans Affairs Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Saline Nasal Spray
Placebo Comparator
|
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other Names:
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Experimental: Oxytocin
40 IU Oxytocin
|
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in social cognition task performance
Time Frame: 2-days at least 1-week apart
|
The outcome will be the number of tasks that improve on the oxytocin day compared to the placebo day in a panel of tasks designed to measure the subject's level of social cognition.
Participants will complete social cognition tasks, which include the Auction Task, Devil's Task, Ultimatum Task, Verbal Prosody, Effort Expenditure for Rewards Task (EEfRT), and Passive Viewing Eyetracking.
|
2-days at least 1-week apart
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire
Time Frame: 1 day
|
The ECR is used to evaluate the construct of adult attachment.
The scale involves 36 itemized statements split into four parts, each part referring to a different attachment figure.
Participants rank each item using a 7-point likert scale.
|
1 day
|
Childhood Trauma Questionnaire (CTQ)
Time Frame: 1 day
|
The CTQ is a brief survey of 6 early traumatic experiences, including death, divorce, violence, sexual abuse, illness or other.
The scale determines and assesses an individual's understanding of their childhood trauma, if applicable.
|
1 day
|
Emotional Quotient Scale (EQS)
Time Frame: 1 day
|
The EQ is a 60-item self-report questionnaire that is designed to measure empathy in adults.
Participants use a 4 item likert scale to record their responses (1=definitely agree, 4= definitely disagree).
|
1 day
|
Kinsey Scale
Time Frame: 1 day
|
The Kinsey scale attempts to describe a person's sexual orientation using a scale from 0 (i.e.
heterosexual) to 6 (i.e.
homosexual).
|
1 day
|
Pre-morbid IQ Questionnaire (AmNART)
Time Frame: 1 day
|
The American National Adult Reading Test (AMNART) is an instrument used to estimate premorbid verbal intelligence quotient (IQ) in adults.
Participants are shown 45 words one at a time and are asked to read the word aloud.
The scorer then writes 0 if the participant read the word incorrectly or 1 if the pronunciation is correct.
|
1 day
|
Change in Working Memory capacity
Time Frame: 2-days at least 1-week apart
|
This task determines a participant's working memory capacity using the University of Maryland Letter Number Span Assessment.
This asks 24 questions of increasing working memory difficulty and the total correct is calculated.
Investigators will measure the change in the total correct between oxytocin and placebo days.
|
2-days at least 1-week apart
|
Change in Auditory Perception correctness
Time Frame: 2-days at least 1-week apart
|
The Sound Sweeps task determines auditory perception ability by measuring changes in pitches to sounds.
Investigators will measure the change in the total correct responses between oxytocin and placebo days.
|
2-days at least 1-week apart
|
Change in Auditory Perception reaction time
Time Frame: 2-days at least 1-week apart
|
The Sound Sweeps task determines auditory perception ability by measuring changes in pitches to sounds.
Investigators will measure the change in the reaction time between oxytocin and placebo days.
|
2-days at least 1-week apart
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Joshua D Woolley, MD/PhD, University of California San Francisco, San Francisco Veterans Affairs Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10-01508
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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