An Early Phase 1 interventional study of Oxytocin and Saline Nasal Spray in Schizophrenia, Oxytocin and Social Cognition, sponsored by University of California, San Francisco. Completed at 2 sites in United States. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-05-21.
Sponsored by University of California, San Francisco · Early Phase 1, Interventional, and Treatment
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 examine the effects of exogenous oxytocin on patterns of neural activation as measured by fMRI during a well-characterized affect-labeling task in patients with recent-onset schizophrenia and healthy comparison subjects.
Hypothesis A: Patients will exhibit amygdalar hyperactivity and PNS hypo-activity when passively viewing faces, which will be normalized by administration of oxytocin.
Hypothesis B: Patients will exhibit hypo-activity of the vPFC when affectively labeling faces and this hypo-activity will be normalized by oxytocin administration.
3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.
This study's enrollment of 59 is below the median of 70 across 2,872 interventional studies indexed under Schizophrenia.
Browse Schizophrenia studies →University of California, San Francisco is the lead sponsor of 2,132 studies on the registry; 375 are open to participants now.
Of its 262 completed or terminated interventional studies of FDA-regulated products, 196 (75%) have results posted.
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Inclusion Criteria for Patients:
Inclusion Criteria for Healthy Controls:
Exclusion Criteria for Patients and Healthy Controls:
Additional Exclusion Criteria for Patients and Healthy Controls:
40 IU Oxytocin
Drug: Oxytocin
Placebo Comparator
Drug: Saline Nasal Spray
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Also known as: Syntocinon
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
Also known as: Placebo
Change in fMRI neural activation patterns
During tasks in which participants will see and hear various stimuli, investigators will measure the change in neural activity in the medial prefrontal cortex and the temporoparietal junction between placebo and oxytocin testing days using the fMRI 3T Siemens Skyra scanner.
Time frame: 2-days at least 1-week apart
Quality of Life Scale (QLS)
The QLS is a 21-item clinical rating scale where the interviewer rates the participant's responses on a scale of 1-6 where 6 indicates no impairment. In the fMRI study an abbreviated version of the QLS is used that includes 9 of the 21 items. The 9 items are each derived from the sections examining interpersonal relations, occupational role functioning, intrapsychic foundations, and common objects.
Time frame: 1 day
Social Functioning Scale (SFS)
The SFS is designed to assess a subject's social skills and performance, and to measure functions that are of importance for schizophrenic patients. It is a 79-item scale completed by the subject.
Time frame: 1 day
UCLA Loneliness Scale
The UCLA Loneliness Scale assesses the loneliness level of participants. It is a 20-item scale where responses are measured from O ("I often feel this way") to N ("I never feel this way").
Time frame: 1 day
Experiences in Close Relationships - Relationship Structures (ECR-RS)
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.
Time frame: 1 day
Parental Bonding Instrument (PBI)
The PBI measures fundamental parenting styles as perceived the child. The questionnaire is retrospective in that it asks the adult participant to answer the questions based on how they remember their parents to be during up until they were 16 years old. The measure is completed for both mothers and fathers separately. There are 25 questions where half the questions are focused on how the parent cared for them and half are focused on how the parents protected them. A likert scale is used to measure responses where 1 is agree (i.e. very like) and 4 is disagree (i.e. very dislike).
Time frame: 1 day
Premorbid IQ test (AmNART)
The American National Adult Reading Test (AMNART) is an instrument used to estimate premorbid verbal 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.
Time frame: 1 day
Childhood Trauma Questionnaire (CTQ)
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.
Time frame: 1 day
Emotional Quotient Scale (EQS)
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).
Time frame: 1 day
Kinsey Scale
The Kinsey scale attempts to describe a person's sexual orientation using a scale from 0 (i.e. heterosexual) to 6 (i.e. homosexual).
Time frame: 1 day
Socioeconomic Status (SES)
This assess participants' socioeconomic status through their educational level and occupational level using a scale from 1 (i.e. professional, higher executive level) to 7 (i.e. less than 7 years of school, unskilled employee). This scale is also used for the participants' primary and secondary caretakers.
Time frame: 1 day
This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.
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