SchizophreniaEarly Phase 1MEGNCT02568709
Oxytocin MEG Study
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 1 site in United States.
Trial summary
The specific aim of this proposal is to investigate the neurophysiological mechanisms of oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using magnetoencephalography. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia, Oxytocin, Magnetoencephalography (MEG)
- What is being tested?
- Oxytocin and Saline Nasal Spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2012to Dec 2016
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-40 years of age
- Male
- Must comprehend English
- Meet DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder
- None or only minor changes to medications in the past week
- Able to use nasal spray
Show all 15Show fewer
- Must be capable of providing informed consent
- Clinically stable
- 18-40 years of age
- Male
- Must comprehend English
- No diagnosis of mental disorder according to DSM-IV TR
- Able to use nasal spray
- Must be capable of providing informed consent
- Clinically stable
Who cannot join
- Female
- Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
- 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
- A pacemaker, extensive dental work, or any magnetic metal implants
- Any history of severe brain trauma
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Effects of Oxytocin on Neural Activation Patterns During Social Cognitive Tasks in Patients With Schizophrenia
The specific aim of this proposal is to investigate the neurophysiological mechanisms of oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using magnetoencephalography.
Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will be normalized.
Read more
Hypothesis B: When OT is administered to patients with schizophrenia, the decreased functional connectivity (FC) between the amygdala, FG, and ACC will be normalized.
By elucidating the neurophysiological mechanisms of OT administration on emotional face processing, investigators will bee able to:
- understand the pathophysiology of the functionally debilitating social cognitive deficits of schizophrenia,
- test the efficacy of OT in normalizing the neural abnormalities underlying these social deficits, and
- develop and optimize novel treatments for these currently untreatable deficits.
- Being tested
- Oxytocin, Saline Nasal Spray
- Keywords
- Oxytocin, Syntocinon, Social Cognition, Schizophrenia, Magnetoencephalography (MEG)
- 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 |
|---|---|---|
| Interventional | Active comparator | 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 MEG neural activation patterns
During tasks in which participants will see and hear various stimuli, investigators will measure the change in neural activity in the amygdala, the dorsal anterior cingulate cortex, as well as the fusiform gyrus using the MEG scanner.
Measured: Oxytocin and placebo administration days at least 1-week apart
Secondary outcomes (10)
Change in performance on Facial Recognition Task
In the Facial Recognition Task, subjects will be presented with various computerized emotional stimuli and will be asked to make a choice. Participants will then respond to the stimuli by pressing a either left or right on the control box and their reaction time will be measured.
Measured: Oxytocin and placebo administration days at least 1-week apart
Change in performance on International Affective Picture System (IAPS) task
In the IAPS Tasks, subjects will view images of people, objects, and scenes from the IAPS (International Affective Picture System). Participants will then respond by pressing a either left or right on the control box to chose a number from 1 (i.e. least disturbing) to 9 (i.e. most disturbing) and their reaction time will be measured.
Measured: Oxytocin and placebo administration days at least 1-week apart
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) Questionnaire
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
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
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
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
Fagerstom Nicotine Dependence Test
The FNDT is the standard measure of an individual's physical addiction to nicotine. The test contains six items to evaluate the quantity of cigarette consumption, the compulsion to use, and dependence.
Measured: 1 day
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 this 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startFeb 2012
- Primary completionDec 2016
- Study completionDec 2016
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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- 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
- NCT02568709
- Sponsor's protocol ID
- 12-08411
- Acronym
- MEG
- Status last verified
- May 2019
- First submitted
- 29 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
- Effects of Oxytocin on Neural Activation Patterns During Social Cognitive Tasks in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT02568709
- Acronym / sponsor ID
- MEG / 12-08411
- Keywords
- Oxytocin, Syntocinon, Social Cognition, Schizophrenia, Magnetoencephalography (MEG)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 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.
The specific aim of this proposal is to investigate the neurophysiological mechanisms of oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using magnetoencephalography.
Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will be normalized.
Hypothesis B: When OT is administered to patients with schizophrenia, the decreased functional connectivity (FC) between the amygdala, FG, and ACC will be normalized.
By elucidating the neurophysiological mechanisms of OT administration on emotional face processing, investigators will bee able to:
- understand the pathophysiology of the functionally debilitating social cognitive deficits of schizophrenia,
- test the efficacy of OT in normalizing the neural abnormalities underlying these social deficits, and
- develop and optimize novel treatments for these currently untreatable deficits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Active comparator | Drug: Oxytocin40 IU Oxytocin |
| Saline Nasal Spray | Placebo comparator | Drug: Saline Nasal SprayPlacebo Comparator |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (15 listed)
- 18-40 years of age
- Male
- Must comprehend English
- Meet DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder
- None or only minor changes to medications in the past week
Key exclusion criteria (7 listed)
- Female
- Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
- 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
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 | Interventional |
| 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 MEG neural activation patterns
Time frame: Oxytocin and placebo administration 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 amygdala, the dorsal anterior cingulate cortex, as well as the fusiform gyrus using the MEG scanner.
10 secondary outcomes
Change in performance on Facial Recognition Task
Time frame: Oxytocin and placebo administration days at least 1-week apart
Change in performance on International Affective Picture System (IAPS) task
Time frame: Oxytocin and placebo administration days at least 1-week apart
UCLA Loneliness Scale
Time frame: 1 day
Experiences in Close Relationships-Relationship Structures (ECR-RS) Questionnaire
Time frame: 1 day
Childhood Trauma Questionnaire (CTQ)
Time frame: 1 day
Parental Bonding Instrument (PBI)
Time frame: 1 day
Emotional Quotient Scale (EQS)
Time frame: 1 day
Fagerstom Nicotine Dependence Test
Time frame: 1 day
Quality of Life Scale (QLS)
Time frame: 1 day
Social Functioning Scale (SFS)
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
1 site 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 1 site 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 15 inclusion and 7 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 1 site 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 MEG neural activation patterns (time frame: Oxytocin and placebo administration 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.