SchizophreniaEarly Phase 1ASO-fMRINCT02566356
Adult Study Oxytocin - fMRI
A Early Phase 1 study testing Oxytocin and Saline Nasal Spray in people with Schizophrenia and Oxytocin, run by University of California, San Francisco at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Oxytocin, Social Cognition
- What is being tested?
- Oxytocin and Saline Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2012to Sep 2017
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- SCID-IV confirmed diagnosis of schizophrenia or schizoaffective disorder
- Clinically stable
- No changes to medications for the past week
- Male
- SCID-IV confirmed no diagnosis of a current Axis I disorder within the last year
Who cannot join
- Meeting criteria for current substance abuse or dependence or illicit drug use within the last month (nicotine use is acceptable) as determined by a Urine Toxicology Drug Screening
- Any illness that affects the nasal passages and impairs the delivery of a nasal spray
- Presence of any neurological or significant medical disorder, including medical illnesses that could interfere with physiological recording such as cardiac arrhythmias
- A pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos
- Pregnancy
- Claustrophpbia
Show all 13Show fewer
- Hearing difficulties
- A history of seizures
- Failure to receive a passing score on the reading test
- Additional Exclusion Criteria for Patients and Healthy Controls:
- Taking any psychotropic medication or any medication that affects the autonomic or cardiovascular systems.
- Schizophrenia or other psychotic disorder in a first degree relative
- Failure to receive a passing score on the MOCA
Trial locations and contacts
2 sites in 1 country.
United States2 sites
San Francisco Veterans Affairs Medical Center
San Francisco, California, 94121
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - fMRI
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.
Read more
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.
- Being tested
- Oxytocin, Saline Nasal Spray
- Keywords
- Oxytocin, Syntocinon, Social Cognition, Schizophrenia, Functional Magnetic Resonance Imaging (fMRI)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxytocinDrug
Also called Syntocinon
40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
Saline Nasal SprayDrug
Also called Placebo
40 IU of the saline nasal spray will be administered once at the beginning of the visit.
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin | Experimental | 40 IU Oxytocin Receives: Drug: Oxytocin |
| Saline Nasal Spray | Placebo comparator | Placebo Comparator Receives: Drug: Saline Nasal Spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2-days at least 1-week apart
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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").
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2015 (estimated)
- Study startSep 2012
- Primary completionSep 2017
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Responsible party
- Principal investigator, Joshua Woolley, University of California, San Francisco
- Investigators
- Josh D Woolley, MD/PhD, Principal investigator, University of California San Francisco, San Francisco Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02566356
- Sponsor's protocol ID
- 12-09654
- Acronym
- ASO-fMRI
- Status last verified
- May 2019
- First submitted
- 30 Sep 2015
- Last updated
- 21 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Effects of Oxytocin on Social Cognition in Schizophrenia - fMRI
- ClinicalTrials.gov ID
- NCT02566356
- Acronym / sponsor ID
- ASO-fMRI / 12-09654
- Keywords
- Oxytocin, Syntocinon, Social Cognition, Schizophrenia, Functional Magnetic Resonance Imaging (fMRI)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Study start
- Sep 2012
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 2 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oxytocin | Experimental | Drug: Oxytocin40 IU Oxytocin |
| Saline Nasal Spray | Placebo comparator | Drug: Saline Nasal SprayPlacebo Comparator |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male
- SCID-IV confirmed diagnosis of schizophrenia or schizoaffective disorder
- Clinically stable
- No changes to medications for the past week
- Male
Key exclusion criteria (13 listed)
- Meeting criteria for current substance abuse or dependence or illicit drug use within the last month (nicotine use is acceptable) as determined by a Urine Toxicology Drug Screening
- Any illness that affects the nasal passages and impairs the delivery of a nasal spray
- Presence of any neurological or significant medical disorder, including medical illnesses that could interfere with physiological recording such as cardiac arrhythmias
- A pacemaker, extensive dental work, or any magnetic metal implants and upper body tattoos
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxytocinAlso: Syntocinon40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit. | Drug | Oxytocin |
| Saline Nasal SprayAlso: Placebo40 IU of the saline nasal spray will be administered once at the beginning of the visit. | Drug | Saline Nasal Spray |
Primary outcome
Change in fMRI neural activation patterns
Time frame: 2-days at least 1-week apart
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.
10 secondary outcomes
Quality of Life Scale (QLS)
Time frame: 1 day
Social Functioning Scale (SFS)
Time frame: 1 day
UCLA Loneliness Scale
Time frame: 1 day
Experiences in Close Relationships - Relationship Structures (ECR-RS)
Time frame: 1 day
Parental Bonding Instrument (PBI)
Time frame: 1 day
Premorbid IQ test (AmNART)
Time frame: 1 day
Childhood Trauma Questionnaire (CTQ)
Time frame: 1 day
Emotional Quotient Scale (EQS)
Time frame: 1 day
Kinsey Scale
Time frame: 1 day
Socioeconomic Status (SES)
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Josh D Woolley, MD/PhD principal investigator
University of California San Francisco, San Francisco Veterans Affairs Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Oxytocin and Saline Nasal Spray in people with Schizophrenia and Oxytocin, run by University of California, San Francisco at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fMRI neural activation patterns (time frame: 2-days at least 1-week apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2019.