Healthy Control SubjectsNCT07856381
Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia
An observational study of Healthy Control Subjects and Schizophrenia Diagnosis, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
This study aims to better understand how schizophrenia may affect social thinking, emotion regulation, brain function, and biological processes over time. Two groups will take part in the study: 1. people diagnosed with schizophrenia 2. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Control Subjects, Schizophrenia Diagnosis
- How many people
- 180 participants
- Where
- 1 siteAustria
- Study dates
- 1 Sep 2026to 30 Sep 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants with SZ will be recruited through multiple clinical pathways to ensure adequate sample size and representativeness across the adult lifespan. The primary recruitment source is the specialized outpatient clinic for SZ spectrum disorders at the Department of Psychiatry, MUI, which serves a large catchment area and maintains detailed diagnostic records. Additional participants will be recruited through a collaborating psychiatric hospital and office-based psychiatrists and psychosocial service providers in the region, with whom the Dep. of Psychiatry maintains established referral networks. Patients in the SZ group must have a DSM-5 diagnosis of schizophrenia confirmed by their treating psychiatrist. HC participants will be recruited through advertisements in online platforms, social media, and community outreach.
Who may be able to join
- age 18-70 years at baseline; normal or corrected-to-normal vision; sufficient hearing; fluency in German; willingness and ability to understand and comply with study procedures. Participants must either be healthy adults without any mental health disorder (HC) or have a confirmed DSM-5 diagnosis of SZ.
- clinical stability at assessment, defined as no clinically significant change in psychopathological symptoms and no modification of pharmacotherapy for at least three months prior to study entry, as confirmed by the treating psychiatrist; full remission is not required.
Who cannot join
- incapacity to consent; current or lifetime history of brain surgery or epilepsy; MRI contraindications (unremovable metal parts in the upper body, active implants, claustrophobia); current or past substance abuse disorder (excluding caffeine and nicotine); pregnancy.
- any current or lifetime Axis I psychiatric disorder; first-degree relative with an Axis I disorder; any neurological disorder or other mental health condition; current or past use of psychotropic medication.
- Additional Eligibility Criteria for Cycle-Timed Neuroimaging:
- To minimize hormonal confounding of emotion-regulation-related neural measures, menstruating female participants will be scanned in the early follicular phase (cycle days 1-6), requiring regular menstrual cycles (21-35 days) and a negative pregnancy test at relevant visits.
- Use of hormonal contraception will be recorded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology; Medical University of Innsbruck
Innsbruck, Tyrol, 6020
Alexandra Schlögl, 0043 50 504 23669, alexandra.schloegl@tirol-kliniken.at
About this study
Official title: SilverMinds - Lifespan Trajectories of Social Cognition and Iron Dysregulation in Schizophrenia
This study aims to better understand how schizophrenia may affect social thinking, emotion regulation, brain function, and biological processes over time.
Two groups will take part in the study:
Read more
- people diagnosed with schizophrenia
- healthy adults without schizophrenia
Participants in both groups will complete a series of behavioral tasks and questionnaires. These will assess abilities such as understanding other people, processing social information, and regulating emotions. For participants with schizophrenia, we will also assess clinical symptoms and their severity.
The study includes three assessment visits:
- Baseline: at the beginning of the study
- 12-month follow-up: approximately one year later
- 24-month follow-up: approximately two years later
At all three visits, participants will complete behavioral tests and questionnaires, and blood and hair samples will be collected. These samples may help researchers investigate biological factors that are related to mental health, stress, and changes over time.
Participants will also undergo an MRI brain scan at the baseline visit and again at the 12-month follow-up.
People with schizophrenia may experience changes in thinking, emotions, social functioning, physical health, and brain function across adulthood. However, we still do not fully understand how these changes develop over time or how they differ from normal aging.
By comparing people with schizophrenia with healthy adults of different ages and following them over time, we can study possible differences in aging trajectories. This means examining whether certain abilities, symptoms, biological markers, or brain characteristics change differently with age in people with schizophrenia.
The study uses an accelerated longitudinal design. Instead of following one group of people for many decades, researchers recruit participants from different age groups and follow them for a shorter period. Combining information across these age groups can help researchers estimate longer-term patterns of change.
- Conditions
- Healthy Control Subjects, Schizophrenia Diagnosis
- Keywords
- schizophrenia, social cognition, Brain iron, accelerated longitudinal design, age trajectory, lifespan, Cognitive Dysfunction, Longitudinal Studies, Magnetic Resonance Imaging, Quantitative Susceptibility Mapping, Extracellular Vesicles, Oxidative Stress, Redox Regulation, Glutathione, Hair Proteomics, Psychosocial Functioning, Negative Symptoms, Theory of Mind, Emotion Recognition, Emotion Regulation
- Medical subject headings
- Schizophrenia, Cognitive Dysfunction, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Schizophrenia Group | Group of people with a diagnosis of schizophrenia confirmed by their treating psychiatrist. | |
| Healthy control group | Group absent of any Axis-I Diagnosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Theory of Mind performance
Theory of Mind will be assessed using the EmpaToM task. The outcome will include performance-based indices of cognitive and affective Theory of Mind. Higher scores indicate better ability to infer and understand the mental states of others.
Measured: Baseline, 12 months, and 24 months
Change in attributional style
Attributional style will be assessed using the Internal, Personal and Situational Attributions Questionnaire-Revised. The outcome will measure tendencies to attribute positive and negative social events to internal, personal-external, or situational-external causes; aswell as monocausal-inference-style.
Measured: Baseline, 12 months, and 24 months
Change in emotion recognition performance
Emotion recognition will be assessed using the DiagnosIS Emotion Recognition Task. The outcome will measure accuracy in identifying facial emotional expressions. Higher scores indicate better emotion recognition performance.
Measured: Baseline, 12 months, and 24 months
Change in Emotion Regulation Choice
The Emotion Regulation Choice Task is a behavioral paradigm used to examines whether individuals adapt their choice of emotion regulation strategy according to the intensity of negative emotional stimuli.
It will be used to assess the change in the degree to which strategy choice changes as a function of emotional intensity.
Measured: Baseline, 12 months, 24 months
Secondary outcomes (13)
Change in reflective functioning
Reflective functioning will be assessed using the Reflective Functioning Questionnaire. The outcome will measure certainty and uncertainty about mental states. Scores will be analyzed according to the scoring rules of the instrument.
Measured: Baseline, 12 months, and 24 months
Change in self reported Emotion Regulation
Self reported emotion regulation will be assessed using the Emotion Regulation Questionnaire (ERQ). The ERQ is a 10-item self-report measure assessing the habitual use of two emotion-regulation strategies: cognitive reappraisal and expressive suppression.
Measured: Baseline, 12 months, 24 months
Change in global cognitive functioning
Global cognition will be assessed using the Screen for Cognitive Impairment in Psychiatry. The outcome will provide a standardized measure of cognitive functioning across domains including verbal learning, working memory, verbal fluency, and processing speed. Higher scores indicate better cognitive performance.
Measured: Baseline, 12 months, and 24 months
Change in daily functioning and disability
Daily functioning and disability will be assessed using the World Health Organization Disability Assessment Schedule 2.0. The outcome will measure functioning across cognition, mobility, self-care, interpersonal relationships, life activities, and participation in society. Higher scores indicate greater disability.
Measured: Baseline, 12 months, and 24 months
Change in brain iron distribution measured by quantitative susceptibility mapping
Brain iron distribution will be assessed using quantitative susceptibility mapping (QSM) derived from multi-echo gradient echo MRI.
Measured: Baseline and 12 months
Change in R2* relaxometry measures of brain iron-sensitive signal
R2* values will be derived from multi-echo gradient echo MRI as an iron-sensitive neuroimaging measure.
Measured: Baseline and 12 months
Change in white matter microstructure
White matter microstructure will be assessed using diffusion-weighted MRI. Outcomes will include fractional anisotropy, mean diffusivity, radial diffusivity, and axial diffusivity.
Measured: Baseline and 12 months
Change in resting-state functional connectivity
Resting-state functional connectivity will be assessed using resting-state functional MRI.
Measured: Baseline and 12 months
Change in extracellular vesicle-derived redox markers
Neuronally derived extracellular vesicles will be isolated from plasma samples.
Measured: Baseline, 12 months, and 24 months
Change in hair proteomic signatures
Hair samples will be analyzed using untargeted proteomic profiling. Outcomes will include proteomic signature related to oxidative stress, antioxidant defense, inflammation, mitochondrial bioenergetics, systemic stress, and biological aging.
Measured: Baseline, 12 months, and 24 months
Change in hair cortisol concentration
Hair cortisol concentration will be measured from scalp hair samples as an index of cumulative hypothalamic-pituitary-adrenal axis activity over the preceding months. Higher values indicate higher cumulative cortisol exposure.
Measured: Baseline, 12 months, and 24 months
Change in psychopathological symptom severity
Psychopathological symptoms in participants with schizophrenia will be assessed using the Positive and Negative Syndrome Scale. The outcome will include total and subscale scores for positive symptoms, negative symptoms, and general psychopathology. Higher scores indicate greater symptom severity.
Measured: Baseline, 12 months, and 24 months
Change in negative symptom severity
Negative symptoms will be assessed using the Brief Negative Symptom Scale. The outcome will measure negative symptom domains including anhedonia, asociality, avolition, blunted affect, and alogia. Higher scores indicate greater negative symptom severity.
Measured: Baseline, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2026
- Study start1 Sep 2026
- Primary completionSep 2030 (estimated)
- Study completion30 Sep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Control SubjectsStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden, University of Innsbruck, Austria
- Responsible party
- Principal investigator, Beatrice Frajo-Apor, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07856381
- Sponsor's protocol ID
- SilverMinds
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SilverMinds - Lifespan Trajectories of Social Cognition and Iron Dysregulation in Schizophrenia
- ClinicalTrials.gov ID
- NCT07856381
- Acronym / sponsor ID
- SilverMinds
- Conditions
- Healthy Control Subjects, Schizophrenia Diagnosis
- Keywords
- schizophrenia, social cognition, Brain iron, accelerated longitudinal design, age trajectory, lifespan, Cognitive Dysfunction, Longitudinal Studies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Collaborators
- Technische Universität Dresden, University of Innsbruck, Austria
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- 30 Sep 2030 (estimated)
- First posted
- 2 Oct 2026 (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 aims to better understand how schizophrenia may affect social thinking, emotion regulation, brain function, and biological processes over time.
Two groups will take part in the study:
- people diagnosed with schizophrenia
- healthy adults without schizophrenia
Participants in both groups will complete a series of behavioral tasks and questionnaires. These will assess abilities such as understanding other people, processing social information, and regulating emotions. For participants with schizophrenia, we will also assess clinical symptoms and their severity.
The study includes three assessment visits:
- Baseline: at the beginning of the study
- 12-month follow-up: approximately one year later
- 24-month follow-up: approximately two years later
At all three visits, participants will complete behavioral tests and questionnaires, and blood and hair samples will be collected. These samples may help researchers investigate biological factors that are related to mental health, stress, and changes over time.
Participants will also undergo an MRI brain scan at the baseline visit and again at the 12-month follow-up.
People with schizophrenia may experience changes in thinking, emotions, social functioning, physical health, and brain function across adulthood. However, we still do not fully understand how these changes develop over time or how they differ from normal aging.
By comparing people with schizophrenia with healthy adults of different ages and following them over time, we can study possible differences in aging trajectories. This means examining whether certain abilities, symptoms, biological markers, or brain characteristics change differently with age in people with schizophrenia.
The study uses an accelerated longitudinal design. Instead of following one group of people for many decades, researchers recruit participants from different age groups and follow them for a shorter period. Combining information across these age groups can help researchers estimate longer-term patterns of change.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Schizophrenia Group | – | –Group of people with a diagnosis of schizophrenia confirmed by their treating psychiatrist. |
| Healthy control group | – | –Group absent of any Axis-I Diagnosis |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants with SZ will be recruited through multiple clinical pathways to ensure adequate sample size and representativeness across the adult lifespan. The primary recruitment source is the specialized outpatient clinic for SZ spectrum disorders at the Department of Psychiatry, MUI, which serves a large catchment area and maintains detailed diagnostic records. Additional participants will be recruited through a collaborating psychiatric hospital and office-based psychiatrists and psychosocial service providers in the region, with whom the Dep. of Psychiatry maintains established referral networks. Patients in the SZ group must have a DSM-5 diagnosis of schizophrenia confirmed by their treating psychiatrist. HC participants will be recruited through advertisements in online platforms, social media, and community outreach.
Key inclusion criteria (2 listed)
- age 18-70 years at baseline; normal or corrected-to-normal vision; sufficient hearing; fluency in German; willingness and ability to understand and comply with study procedures. Participants must either be healthy adults without any mental health disorder (HC) or have a confirmed DSM-5 diagnosis of SZ.
- clinical stability at assessment, defined as no clinically significant change in psychopathological symptoms and no modification of pharmacotherapy for at least three months prior to study entry, as confirmed by the treating psychiatrist; full remission is not required.
Key exclusion criteria (5 listed)
- incapacity to consent; current or lifetime history of brain surgery or epilepsy; MRI contraindications (unremovable metal parts in the upper body, active implants, claustrophobia); current or past substance abuse disorder (excluding caffeine and nicotine); pregnancy.
- any current or lifetime Axis I psychiatric disorder; first-degree relative with an Axis I disorder; any neurological disorder or other mental health condition; current or past use of psychotropic medication.
- To minimize hormonal confounding of emotion-regulation-related neural measures, menstruating female participants will be scanned in the early follicular phase (cycle days 1-6), requiring regular menstrual cycles (21-35 days) and a negative pregnancy test at relevant visits.
- Use of hormonal contraception will be recorded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Theory of Mind performance
Time frame: Baseline, 12 months, and 24 months
Theory of Mind will be assessed using the EmpaToM task. The outcome will include performance-based indices of cognitive and affective Theory of Mind. Higher scores indicate better ability to infer and understand the mental states of others.
Change in attributional style
Time frame: Baseline, 12 months, and 24 months
Attributional style will be assessed using the Internal, Personal and Situational Attributions Questionnaire-Revised. The outcome will measure tendencies to attribute positive and negative social events to internal, personal-external, or situational-external causes; aswell as monocausal-inference-style.
Change in emotion recognition performance
Time frame: Baseline, 12 months, and 24 months
Emotion recognition will be assessed using the DiagnosIS Emotion Recognition Task. The outcome will measure accuracy in identifying facial emotional expressions. Higher scores indicate better emotion recognition performance.
Change in Emotion Regulation Choice
Time frame: Baseline, 12 months, 24 months
The Emotion Regulation Choice Task is a behavioral paradigm used to examines whether individuals adapt their choice of emotion regulation strategy according to the intensity of negative emotional stimuli. It will be used to assess the change in the degree to which strategy choice changes as a function of emotional intensity.
13 secondary outcomes
Change in reflective functioning
Time frame: Baseline, 12 months, and 24 months
Change in self reported Emotion Regulation
Time frame: Baseline, 12 months, 24 months
Change in global cognitive functioning
Time frame: Baseline, 12 months, and 24 months
Change in daily functioning and disability
Time frame: Baseline, 12 months, and 24 months
Change in brain iron distribution measured by quantitative susceptibility mapping
Time frame: Baseline and 12 months
Change in R2* relaxometry measures of brain iron-sensitive signal
Time frame: Baseline and 12 months
Change in white matter microstructure
Time frame: Baseline and 12 months
Change in resting-state functional connectivity
Time frame: Baseline and 12 months
Change in extracellular vesicle-derived redox markers
Time frame: Baseline, 12 months, and 24 months
Change in hair proteomic signatures
Time frame: Baseline, 12 months, and 24 months
Change in hair cortisol concentration
Time frame: Baseline, 12 months, and 24 months
Change in psychopathological symptom severity
Time frame: Baseline, 12 months, and 24 months
Change in negative symptom severity
Time frame: Baseline, 12 months, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Control Subjects and Schizophrenia Diagnosis, run by Medical University Innsbruck at 1 site in Austria.
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 5 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: looking for participants now, as of the sponsor's last update on 2 Oct 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 Austria. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christopher Schaar, M.Sc. (0043 512 9003 81298, christopher.schaar@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Theory of Mind performance (time frame: Baseline, 12 months, and 24 months). The study lists 4 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 Oct 2026.