Adult Oxytocin Study (OT)
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|ClinicalTrials.gov Identifier: NCT02577575|
Recruitment Status : Completed
First Posted : October 16, 2015
Last Update Posted : October 19, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Oxytocin Social Cognition||Drug: Oxytocin Drug: Saline Nasal Spray||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||The Effects of Oxytocin on Social Cognition in Patients With Schizophrenia|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
40 IU Oxytocin
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Other Name: Syntocinon
Placebo Comparator: Saline Nasal Spray
Drug: Saline Nasal Spray
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Other Name: Placebo
- 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.
- 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.
- 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.
- 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.
- 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).
- 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).
- 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.
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577575
|United States, California|
|San Francisco Veterans Affairs Medical Center|
|San Francisco, California, United States, 94121|
|University of California, San Francisco|
|San Francisco, California, United States, 94143|
|Principal Investigator:||Joshua D Woolley, MD/PhD||University of California San Francisco, San Francisco Veterans Affairs Medical Center|