Understanding Lifespan Trajectories of Social Cognition, Brain Microstructure and Iron Dysregulation in Schizophrenia

NCT07856381 | Recruiting

• 1 other identifier: SilverMinds
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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. 1.people diagnosed with schizophrenia
2. 2.healthy adults without schizophrenia
3. 3.Baseline: at the beginning of the study
4. 4.12-month follow-up: approximately one year later
5. 5.24-month follow-up: approximately two years later

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; Attributional Style; NDEV; functional outcome

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, 12 months, 24 months

Secondary Outcomes (13)

• Change in reflective functioning

  Baseline, 12 months, and 24 months

• Change in self reported Emotion Regulation

  Baseline, 12 months, 24 months

• Change in global cognitive functioning

  Baseline, 12 months, and 24 months

• Change in daily functioning and disability

  Baseline, 12 months, and 24 months

• Change in brain iron distribution measured by quantitative susceptibility mapping

  Baseline and 12 months

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University Innsbruck: lead
• Technische Universität Dresden: collaborator
• University of Innsbruck, Austria: collaborator

Study Sites (1)

Department of Psychiatry, Psychotherapy, Psychosomatics and Medical Psychology; Medical University of Innsbruck

Innsbruck, Tyrol, 6020, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Samples with whole blood (9 ml / Time Point) Hair Samples (\~1cm / Time Point)

MeSH Terms

Conditions

Schizophrenia; Cognitive Dysfunction; Emotional Regulation

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders; Self-Control; Social Behavior; Behavior

Central Study Contacts

Christopher Schaar, M.Sc.

CONTACT

0043 512 9003 81298; christopher.schaar@i-med.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., PhD.

Study Record Dates

• First Submitted: September 23, 2026
• First Posted: October 2, 2026
• Study Start: September 1, 2026
• Primary Completion (Estimated): September 1, 2030
• Study Completion (Estimated): September 30, 2030
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)