SchizophreniaEarly Phase 1ASO-BehavioralNCT02567032
Adult Study Oxytocin - Behavioral
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 and other psychotic disorders. Read more about this study
- Who is it for?
- Ages 18 to 45 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
- 324 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Aug 2019
- 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 to 45 years of age
- Clinically stable
- English Speaking
- Meet DSM-5 criteria for schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder with psychotic features, or brief psychotic disorder
- No or at most only minor changes to medications in the past week
- Able to use nasal spray
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- Must be capable of providing informed consent
- 18 to 45 years of age
- Clinically stable
- English Speaking
- No diagnosis of mental disorder according to DSM-5, not including mild alcohol use disorder or mild cannabis use disorder
- Able to use nasal spray
- Must be capable of providing informed consent
Who cannot join
- Active substance and alcohol use disorder in the past month as determined by the DSM-5 criteria, not including cannabis use disorder
- Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
- Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
- Hearing deficits
- Pregnancy
- Severe brain trauma
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- Active substance and moderate/severe alcohol use disorder, or mood disorder in the past month as determined by the DSM-5 criteria, not including mild alcohol use disorder or mild cannabis use disorder
- Meet for a current psychiatric disorder according to DSM-5 criteria
- Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
- Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
- Hearing deficits
- Pregnancy
- Severe brain trauma
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 - Behavioral
In this study, investigators will examine the behavioral effects and neurophysiological mechanisms of the pro-social neuropeptide oxytocin in patients with recent-onset schizophrenia and other psychotic disorders. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders.
Aim 1: To quantify the effects of exogenous oxytocin on social cognition and behavior in patients with recent-onset schizophrenia.
Read more
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.
Read the detailed description
Part 2: A supplementary study will be added to the proposed parent study, which includes additional behavioral testing consisting of several social cognition computer tasks, clinical assessments, physiological measurements, and questionnaires. The study will be conducted with the same study arms and study interventions as in the proposed parent study. For this supplementary study, the inclusion criteria has broadened to include patients with bipolar disorder with psychotic features and brief psychotic disorder.
- Conditions
- Schizophrenia, Oxytocin, Social Cognition, Psychotic Disorders
- Being tested
- Oxytocin, Saline Nasal Spray
- Keywords
- Oxytocin, Syntocinon, Social Cognition, Schizophrenia, Psychosis, Schizoaffective Disorder, Schizophreniform Disorder, Psychotic Disorders
- Medical subject headings
- Schizophrenia, Psychotic Disorders
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 Social Cognition Task Performance
Participants will undergo computer tasks that measure social cognition. Tasks will involve verbal responses, pressing buttons at specific times, listening, and viewing audio-visual stimuli. Investigators will be measuring the difference in accuracy and verbal content of the responses on the oxytocin day compared to the placebo day.
Measured: Through study completion, 2-3 weeks
Secondary outcomes (2)
Physiological Measurements
Sensors will be attached to measure heart rate, respiration, and skin conductance during computer tasks.
Measured: Through study completion, 2-3 weeks
Questionnaire
Participants will be asked questions about their current positive and negative symptoms, medical and psychiatric history. Self-report responses will be saved in writing or audio recording.
Measured: At baseline visit, up to 4 hours
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 startOct 2010
- Primary completionAug 2019
- Study completionAug 2019
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
- 324 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
- NCT02567032
- Sponsor's protocol ID
- 10-02262
- Acronym
- ASO-Behavioral
- Status last verified
- Feb 2020
- First submitted
- 29 Sep 2015
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. 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 - Behavioral
- ClinicalTrials.gov ID
- NCT02567032
- Acronym / sponsor ID
- ASO-Behavioral / 10-02262
- Conditions
- Schizophrenia, Oxytocin, Social Cognition, Psychotic Disorders
- Keywords
- Oxytocin, Syntocinon, Social Cognition, Schizophrenia, Psychosis, Schizoaffective Disorder, Schizophreniform Disorder, Psychotic Disorders
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- San Francisco Veterans Affairs Medical Center
- Study start
- Oct 2010
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (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 and other psychotic disorders. Such research is a necessary first step towards identifying whether intranasal oxytocin administration can serve as an adjunct treatment for social impairments in schizophrenia and other psychotic disorders.
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.
Detailed description
Part 2: A supplementary study will be added to the proposed parent study, which includes additional behavioral testing consisting of several social cognition computer tasks, clinical assessments, physiological measurements, and questionnaires. The study will be conducted with the same study arms and study interventions as in the proposed parent study. For this supplementary study, the inclusion criteria has broadened to include patients with bipolar disorder with psychotic features and brief psychotic disorder.
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 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- 18 to 45 years of age
- Clinically stable
- English Speaking
- Meet DSM-5 criteria for schizophrenia, schizophreniform, schizoaffective disorder, bipolar disorder with psychotic features, or brief psychotic disorder
- No or at most only minor changes to medications in the past week
Key exclusion criteria (13 listed)
- Active substance and alcohol use disorder in the past month as determined by the DSM-5 criteria, not including cannabis use disorder
- Subjects with atrophic rhinitis, recurrent nose bleeds, severe brain trauma, and cranial-surgical procedures (hypophysectomy)
- Medical conditions like congestion or sinus problems that could interfere with the study as per the opinion of the investigator
- Hearing deficits
- 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 Social Cognition Task Performance
Time frame: Through study completion, 2-3 weeks
Participants will undergo computer tasks that measure social cognition. Tasks will involve verbal responses, pressing buttons at specific times, listening, and viewing audio-visual stimuli. Investigators will be measuring the difference in accuracy and verbal content of the responses on the oxytocin day compared to the placebo day.
2 secondary outcomes
Physiological Measurements
Time frame: Through study completion, 2-3 weeks
Questionnaire
Time frame: At baseline visit, up to 4 hours
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 26 Feb 2020.
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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 13 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 26 Feb 2020. 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 Social Cognition Task Performance (time frame: Through study completion, 2-3 weeks). 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 26 Feb 2020.