SchizophreniaNCT04681807
Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia
A study testing Emotion Recognition Training in people with Schizophrenia, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
Trial summary
Social cognition is an individual's ability to perceive, process, understand, and react to other individuals in a social situation. Social cognition is impaired in individuals with schizophrenia, including difficulty recognizing others' emotions. Read more about this study
- Who is it for?
- Ages 15 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Emotion Recognition Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteCanada
- Study dates
- 21 Jul 2021to 22 Aug 2025
- Phase
- Interventional
- 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 15 to 35 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Between (or equal to) 15-35 years of age
- Ability to read/speak fluent English
- Diagnosis of SZ, schizoaffective disorder or schizophreniform confirmed for 1st degree relative by referring psychiatrist or two reliable informants (using the adapted FIGS questionnaire).
Who cannot join
- No diagnosis of psychosis related disorder
- Significant neurological or medical disorders that may produce cognitive impairment
- Current epilepsy or previous history of seizures
- Previous head injury with current continuing symptoms (i.e., cognitive ability, dizziness, etc.)
- Recent history of substance abuse or dependence (within past 3 months)
- MRI contraindication (e.g. metallic head implant, history of seizure, pacemaker, pregnancy, etc.)
- Current IQ < 70 as measured by the Wechsler Abbreviated Scale of Intelligence Scale (WASI)
Trial locations and contacts
1 site in 1 country.
About this study
Social cognition is an individual's ability to perceive, process, understand, and react to other individuals in a social situation. Social cognition is impaired in individuals with schizophrenia, including difficulty recognizing others' emotions. A promising treatment avenue for emotion recognition problems in individuals with schizophrenia is continued practice with various facial expression recognition training programs. First degree relatives of someone with schizophrenia are considered at familial high risk (FHR) for the illness, because of its high level of heritability. It is therefore critical to explore if these emotion recognition training programs could also benefit people at FHR. In this current study, the investigators aim to explore the social-cognitive profiles and their neural correlates in FHR individuals. The investigators also aim to explore the potential efficacy of an emotion recognition intervention to improve this ability in FHR individuals.
Read the detailed description
All participants will complete a battery of social cognitive tests as well as an fMRI scan to explore the neuronal correlates underlying lower social cognitive functioning observed in FHR individuals. FHR youth will be randomized into either a 4-session emotion recognition training exercise program on iPad or a control training program on iPad that includes commercial games and control emotional attention bias training.
- Conditions
- Schizophrenia
- Being tested
- Emotion Recognition Training, Control Training
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Emotion Recognition TrainingBehavioural
Participants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of an emotion recognition training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) .
Control TrainingBehavioural
Participants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of a control training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) .
| Study group | Role | What they receive |
|---|---|---|
| Emotion Recognition Training | Experimental | Not described Receives: Behavioral: Emotion Recognition Training |
| Control Training | Other | Control Receives: Behavioral: Control Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in emotion recognition performance from baseline - PENN Emotion Recognition Test
Penn Emotion Recognition test - tests the participant's ability to recognize emotion from facial expressions
Measured: baseline and post treatment (1 month)
Change in brain activity during emotion recognition tasks from baseline
Brain activity as measured using task-based functional magnetic resonance imaging (fMRI).
Measured: baseline and post treatment (1 month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start21 Jul 2021
- Primary completion22 Aug 2025
- Study completion22 Aug 2025
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to either 7 visits over a period of 1 month of an emotion recognition training condition or 7 visits over a period of one month of active control training condition.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Royal Ottawa Mental Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Synthia Guimond, The Royal Ottawa Mental Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04681807
- Sponsor's protocol ID
- 2019033
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2020
- Last updated
- 2 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data collected from this study may be shared with other researchers at the Royal's Institute of Mental Health Research for analyses and re-analyses. Variables of the study and scripts used for analyses will be made available to the public. De-identified data will also be shared with the general public upon request. Data that can connect with participants' identity will NOT be used or shared for analyses.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Social Cognition in Youth Who Have a First Degree Relative With Schizophrenia
- ClinicalTrials.gov ID
- NCT04681807
- Acronym / sponsor ID
- 2019033
- Conditions
- Schizophrenia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- The Royal Ottawa Mental Health CentreUniversity, hospital or other
- Study start
- 21 Jul 2021 (actual)
- Primary completion
- 22 Aug 2025 (actual)
- Study completion
- 22 Aug 2025 (actual)
- First posted
- 23 Dec 2020 (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.
Social cognition is an individual's ability to perceive, process, understand, and react to other individuals in a social situation. Social cognition is impaired in individuals with schizophrenia, including difficulty recognizing others' emotions. A promising treatment avenue for emotion recognition problems in individuals with schizophrenia is continued practice with various facial expression recognition training programs. First degree relatives of someone with schizophrenia are considered at familial high risk (FHR) for the illness, because of its high level of heritability. It is therefore critical to explore if these emotion recognition training programs could also benefit people at FHR. In this current study, the investigators aim to explore the social-cognitive profiles and their neural correlates in FHR individuals. The investigators also aim to explore the potential efficacy of an emotion recognition intervention to improve this ability in FHR individuals.
Detailed description
All participants will complete a battery of social cognitive tests as well as an fMRI scan to explore the neuronal correlates underlying lower social cognitive functioning observed in FHR individuals. FHR youth will be randomized into either a 4-session emotion recognition training exercise program on iPad or a control training program on iPad that includes commercial games and control emotional attention bias training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to either 7 visits over a period of 1 month of an emotion recognition training condition or 7 visits over a period of one month of active control training condition.
| Arm | Type | Receives |
|---|---|---|
| Emotion Recognition Training | Experimental | Behavioral: Emotion Recognition Training |
| Control Training | Other | Behavioral: Control TrainingControl |
Who may qualify
- Ages
- 15 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Between (or equal to) 15-35 years of age
- Ability to read/speak fluent English
- Diagnosis of SZ, schizoaffective disorder or schizophreniform confirmed for 1st degree relative by referring psychiatrist or two reliable informants (using the adapted FIGS questionnaire).
Key exclusion criteria (7 listed)
- No diagnosis of psychosis related disorder
- Significant neurological or medical disorders that may produce cognitive impairment
- Current epilepsy or previous history of seizures
- Previous head injury with current continuing symptoms (i.e., cognitive ability, dizziness, etc.)
- Recent history of substance abuse or dependence (within past 3 months)
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 |
|---|---|---|
| Emotion Recognition TrainingParticipants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of an emotion recognition training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) . | Behavioural | Emotion Recognition Training |
| Control TrainingParticipants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of a control training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) . | Behavioural | Control Training |
Primary outcome
Change in emotion recognition performance from baseline - PENN Emotion Recognition Test
Time frame: baseline and post treatment (1 month)
Penn Emotion Recognition test - tests the participant's ability to recognize emotion from facial expressions
Change in brain activity during emotion recognition tasks from baseline
Time frame: baseline and post treatment (1 month)
Brain activity as measured using task-based functional magnetic resonance imaging (fMRI).
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 2 Jan 2026.
- Individual participant dataSharing planned: Yes. De-identified data collected from this study may be shared with other researchers at the Royal's Institute of Mental Health Research for analyses and re-analyses. Variables of the study and scripts used for analyses will be made available to the public. De-identified data will also be shared with the general public upon request. Data that can connect with participants' identity will NOT be used or shared for analyses.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Emotion Recognition Training in people with Schizophrenia, run by The Royal Ottawa Mental Health Centre at 1 site in Canada.
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 3 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 2 Jan 2026. 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 Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 emotion recognition performance from baseline - PENN Emotion Recognition Test (time frame: baseline and post treatment (1 month)). The study lists 2 primary outcomes in all. 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 2 Jan 2026.