SchizophreniaPhase 4NCT03245437
Target Engagement and Response to Oxytocin
A Phase 4 study testing Oxytocin nasal spray, Social Cognition Skills Training and Health Management in people with Schizophrenia, run by University of California, Los Angeles at 1 site in United States.
Trial summary
This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Oxytocin nasal spray, Social Cognition Skills Training and Health Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2018to 31 Jul 2024
- Phase
- Phase 4
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia or schizoaffective disorder
- stable on an antipsychotic medication
Who cannot join
- positive pregnancy test history of head injury
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement
This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.
Read the detailed description
The study will determine whether oxytocin (OT) administration 30 min before a training session enhances the learning of social information in the context of a social cognitive skills training (SCST) program, and it will test a possible mediator of this effect. Subjects with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial design: OT with SCST; Placebo with SCST; OT with training control condition; placebo with training control condition. Target engagement will be measured in an OT challenge (placebo versus OT one week apart) prior to baseline assessment. The measure of target engagement will be EEG mu suppression while observing biological motion. A social cognition battery will be administered at baseline, at midpoint after 6 weeks of SCST, and at completion of training at 12 weeks. The battery will include measures of social cue identification and mentalizing.
- Conditions
- Schizophrenia
- Being tested
- Oxytocin nasal spray, Social Cognition Skills Training, Health Management, Placebo nasal spray
- Keywords
- Social Cognition, Oxytocin
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxytocin nasal sprayDrug
Also called OT
nasal spray
Social Cognition Skills TrainingBehavioural
Also called SCST
Group based training in social cognition skills
Health ManagementBehavioural
Also called HM
Group-based training in mental health management
Placebo nasal sprayDrug
Also called PBO
placebo condition
| Study group | Role | What they receive |
|---|---|---|
| Oxytocin with SCST | Experimental | Oxytocin with SCST (active condition) Receives: Drug: Oxytocin nasal spray; Behavioral: Social Cognition Skills Training |
| Oxytocin with Health Management | Sham comparator | Administration of OT with control psychosocial treatment Receives: Drug: Oxytocin nasal spray; Behavioral: Health Management |
| Placebo with SCST | Placebo comparator | Administration of Placebo with active psychosocial treatment Receives: Behavioral: Social Cognition Skills Training; Drug: Placebo nasal spray |
| Placebo with HM | Placebo comparator | Administration of Placebo with control psychosocial treatment Receives: Behavioral: Health Management; Drug: Placebo nasal spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Cognition Composite Score
We will assess social cognition in two subdomains: (1) social cue identification (Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) branch 1, Ekman, Profile of Nonverbal Sensitivity (PONS); and (2) mentalizing (The Awareness of Social Inference Test (TASIT). and Empathic accuracy) (see below). The primary summary measure for each test will be mean-centered and standardized to create a Z-score. These Z-scores will be averaged to create a single composite score for social cognition that will serve as the primary outcome measure.
Measured: 16 weeks
Secondary outcomes (1)
Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery
Standardized z-score
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2017
- Study start4 Jan 2018
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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, Los AngelesThe 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Stephen R. Marder, University of California, Los Angeles
- Investigators
- Stephen Marder, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03245437
- Sponsor's protocol ID
- OT R33
- Other IDs
- R33MH107564
- Status last verified
- Mar 2025
- First submitted
- 7 Aug 2017
- Last updated
- 21 Mar 2025
- 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 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oxytocin on Social Cognition Training: Relationship to Target Engagement
- ClinicalTrials.gov ID
- NCT03245437
- Acronym / sponsor ID
- OT R33
- Conditions
- Schizophrenia
- Keywords
- Social Cognition, Oxytocin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 4 Jan 2018 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 10 Aug 2017 (actual)
- 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.
This study will measure whether the engagement of intranasal oxytocin with a brain target is related to effects on learning during a social cognition training program.
Detailed description
The study will determine whether oxytocin (OT) administration 30 min before a training session enhances the learning of social information in the context of a social cognitive skills training (SCST) program, and it will test a possible mediator of this effect. Subjects with psychotic disorders will be randomized to one of four groups in a 2 by 2 factorial design: OT with SCST; Placebo with SCST; OT with training control condition; placebo with training control condition. Target engagement will be measured in an OT challenge (placebo versus OT one week apart) prior to baseline assessment. The measure of target engagement will be EEG mu suppression while observing biological motion. A social cognition battery will be administered at baseline, at midpoint after 6 weeks of SCST, and at completion of training at 12 weeks. The battery will include measures of social cue identification and mentalizing.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Oxytocin with SCST | Experimental | Drug: Oxytocin nasal spray, Behavioral: Social Cognition Skills TrainingOxytocin with SCST (active condition) |
| Oxytocin with Health Management | Sham comparator | Drug: Oxytocin nasal spray, Behavioral: Health ManagementAdministration of OT with control psychosocial treatment |
| Placebo with SCST | Placebo comparator | Behavioral: Social Cognition Skills Training, Drug: Placebo nasal sprayAdministration of Placebo with active psychosocial treatment |
| Placebo with HM | Placebo comparator | Behavioral: Health Management, Drug: Placebo nasal sprayAdministration of Placebo with control psychosocial treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Schizophrenia or schizoaffective disorder
- stable on an antipsychotic medication
Key exclusion criteria (1 listed)
- positive pregnancy test history of head injury
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 |
|---|---|---|
| Oxytocin nasal sprayAlso: OTnasal spray | Drug | Oxytocin with Health Management, Oxytocin with SCST |
| Social Cognition Skills TrainingAlso: SCSTGroup based training in social cognition skills | Behavioural | Oxytocin with SCST, Placebo with SCST |
| Health ManagementAlso: HMGroup-based training in mental health management | Behavioural | Oxytocin with Health Management, Placebo with HM |
| Placebo nasal sprayAlso: PBOplacebo condition | Drug | Placebo with HM, Placebo with SCST |
Primary outcome
Social Cognition Composite Score
Time frame: 16 weeks
We will assess social cognition in two subdomains: (1) social cue identification (Managing Emotions component of Mayer-Salovey-Caruso Emotional Intelligence Test (MSCEIT) branch 1, Ekman, Profile of Nonverbal Sensitivity (PONS); and (2) mentalizing (The Awareness of Social Inference Test (TASIT). and Empathic accuracy) (see below). The primary summary measure for each test will be mean-centered and standardized to create a Z-score. These Z-scores will be averaged to create a single composite score for social cognition that will serve as the primary outcome measure.
1 secondary outcome
Composite score of non-social cognition from the MATRICS Consensus Cognitive Battery
Time frame: 16 weeks
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 Mar 2025.
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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.
Stephen Marder, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oxytocin nasal spray, Social Cognition Skills Training and Health Management in people with Schizophrenia, run by University of California, Los Angeles 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 2 inclusion and 1 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 Mar 2025. 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Social Cognition Composite Score (time frame: 16 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 21 Mar 2025.