SchizophreniaSPIRITNCT04968223
Neural Correlates of Social Touch and Interoceptive Perception As Potential Biomarker for Impaired Social Functioning
An observational study of Schizophrenia, run by University of Oldenburg at 1 site in Germany.
Trial summary
Recent studies have shown that certain biomarkers of schizophrenia could help to better assess the individual course of the disease and thus, contribute to more personalized treatment options. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- How many people
- 106 participants
- Where
- 1 siteGermany
- Study dates
- 16 Aug 2021to 30 Nov 2024
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: In- and outpatients of the Department of Psychiatry, University of Oldenburg. Patients meeting the criteria for schizophrenia or schizoaffective disorder according to DSM-V will be included in the study. The patients' diagnosis will be verified via the structured clinical interview for DSM-V. Healthy subjects without family history of psychotic illness (control group). Control group will be matched to the patient sample.
Who may be able to join
- Participant is able to provide consent.
- Diagnosis of schizophrenia or schizoaffective disorder according to DSM-V
- Control group: No psychiatric or neurological illness.
- Fluent in German.
Who cannot join
- The participant does not fulfill requirements for MRI measurements according to safety guidelines.
- Acute suicidality.
- Current substance dependence.
- A history of head trauma or neurological illness.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry, University of Oldenburg
Bad Zwischenahn, 26160
About this study
Recent studies have shown that certain biomarkers of schizophrenia could help to better assess the individual course of the disease and thus, contribute to more personalized treatment options. The aim of the SPIRIT study is to identify potential biomarkers for the prediction of disease-associated outcomes by investigating the neurobiological mechanisms of underlying schizophrenia-related dysfunctions.
Read the detailed description
Alterations in psychosocial functioning are evident from the prodromal phase of schizophrenia and play a crucial role in its chronic course. While recent studies have demonstrated the predictive validity of structural changes in the brain anatomy of patients with schizophrenia, there is a lack of studies assessing the predictive value of disease-associated alterations in the functional brain activity for symptom severity and psychosocial functioning in schizophrenia.
In this longitudinal, observational study, 60 patients with schizophrenia and 40 healthy subjects without family history of psychotic illness will be recruited to investigate differences in behavioural, physiological, and neural correlates of social touch and interoceptive perception between participant groups. Participants' symptom severity and psychosocial functioning level will be examined by a wide range of behavioural, physiological, and neural methods. Potential biomarkers will be identified by estimating the predictive value of initially performed methods on follow-up re-examination of clinical and psychosocial outcomes. Neural readouts include structural and functional magnetic resonance imaging (fMRI) measurements. The fMRI tasks will probe the processing of social touch and interoceptive perception; additionally resting-state connectivity will be assessed. To further investigate pathological distortions of social touch and interoceptive perception, bodily touch allowance maps will be measured and participants will perform a heart-beat discrimination task. Psychometric questionnaires and semi-structured interviews will be used to capture symptom load and level of psychosocial functioning. Long-term effects will be assessed by online questionnaires and semi-structured interviews via phone call 3- and 6 months after initial assessments. The investigators hypothesize that differences in the neural response to social touch as well as in the neural patterns of interoceptive perception could serve as potential biomarkers for psychosocial deficits during the course of the illness. Furthermore, the inclusion of those biomarkers in predictive models could improve the prediction of disease progression and thus, contribute to personalized therapy.
- Conditions
- Schizophrenia
- Keywords
- Biomarker-based prediction, Precision Psychiatry, Schizophrenia, Social functioning, Social Touch, Interoception, fMRI
- Medical subject headings
- Schizophrenia, Social Adjustment
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 |
|---|---|---|
| Patient Group | Patients with Schizophrenia | |
| Control Group | Healthy subjects without family history of psychotic illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neural responses in a social touch task
Participants will be measured with functional magnetic resonance imaging (fMRI) while they perceive different types of social and non-social touch
Measured: One-time baseline assessment
Behavioral responses in a social touch fMRI task
Measured as behavioral ratings during the social touch fMRI task. During the social touch fMRI task, participants rate the comfort of the tactile stimuli on a visual analogue scale.
Measured: One-time baseline assessment
Neural responses in an interoception fMRI task
Participants will be measured with functional magnetic resonance imaging (fMRI) while they perform an interoception task
Measured: One-time baseline assessment
Behavioral responses in an interoception fMRI task
Measured by performance on the interoception task. During the interoception fMRI task, participants rate how intensely they perceived their heartbeat or their stomach on a visual analogue scale.
Measured: One-time baseline assessment
Changes in clinician-rated symptom severity between baseline and follow-ups
Measured by half-structured interviews (e.g. Positive and Negative Syndrome Scale (PANSS); range: 30-210; higher scores indicating more severe symptoms) for disease-related symptoms
Measured: Baseline, 3 and 6 months follow- up after initial baseline assessment
Changes in self-reported symptom severity between baseline and follow-ups
Measured by self-evaluation questionnaires (e.g. Self-assessment of Negative Symptoms (SNS); range 1-20; higher scores indicating more severe symptoms) for disease-related symptoms
Measured: Baseline, 3 and 6 months follow- up after initial baseline assessment
Changes in clinician-rated social-role functioning between baseline and follow-ups
Measured by the clinician-rated the social-role functioning scale (range: 1-10; higher scores indicating higher functioning)
Measured: Baseline, 3 and 6 months follow- up after initial baseline assessment
Changes in self-reported social-role functioning levels between baseline and follow-ups
Measured by the self-evaluation questionnaires for social-role functioning (e.g. Social Network Index (SNI); range 1-12; higher scores indicating higher functioning)
Measured: Baseline, 3 and 6 months follow-up after initial baseline assessment
Secondary outcomes (8)
Bodily maps of social touch
Measured as performance on a bodily maps computer task
Measured: One-time baseline assessment
Attitude towards social touch
Measured by the self-evaluation questionnaire for social touch tolerance (e.g. Social Touch Questionnaire; range 0-4; higher scores indicating higher touch tolerance)
Measured: One-time baseline assessment
Interoceptive accuracy
Measured as performance on a heartbeat discrimination task
Measured: One-time baseline assessment
Interoceptive awareness
Measured by a self-evaluation questionnaire for interoceptive awareness (e.g. Multidimensional Assessment of Interoceptive Awareness (MAIA); range 0-5; higher scores indicating higher interoceptive awareness)
Measured: One-time baseline assessment
Blood parameter
Measured by schizophrenia related, Nuclear Magnetic Resonance spectroscopy (NMR) based metabolomics
Measured: One-time baseline assessment
Urine parameter
Measured by schizophrenia related, Nuclear Magnetic Resonance spectroscopy (NMR) based metabolomics
Measured: One-time baseline assessment
Neural activity at resting state
fMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open.
Measured: One-time baseline assessment
Structural connectivity measure
fMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open.
Measured: One-time baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start16 Aug 2021
- Primary completion15 May 2024
- Study completion30 Nov 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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oldenburg
- Sponsor type
- University, hospital or other
- Collaborators
- Danilo Postin, M.Sc.
- Responsible party
- Principal investigator, Dirk Scheele, University of Oldenburg
- Investigators
- René Hurlemann, Prof., Principal investigator, Department of Psychiatry, University of OldenburgDirk Scheele, Dr., Principal investigator, Department of Psychiatry, University of OldenburgDanilo Postin, M.Sc., Study director, Department of Psychiatry, University of Oldenburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968223
- Sponsor's protocol ID
- SPIRIT
- Acronym
- SPIRIT
- Status last verified
- Dec 2024
- First submitted
- 11 Jun 2021
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Correlates of Social Touch and Interoceptive Perception As Potential Biomarker for Impaired Social Functioning
- ClinicalTrials.gov ID
- NCT04968223
- Acronym / sponsor ID
- SPIRIT / SPIRIT
- Conditions
- Schizophrenia
- Keywords
- Biomarker-based prediction, Precision Psychiatry, Schizophrenia, Social functioning, Social Touch, Interoception, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of OldenburgUniversity, hospital or other
- Collaborators
- Danilo Postin, M.Sc.
- Study start
- 16 Aug 2021 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 20 Jul 2021 (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.
Recent studies have shown that certain biomarkers of schizophrenia could help to better assess the individual course of the disease and thus, contribute to more personalized treatment options. The aim of the SPIRIT study is to identify potential biomarkers for the prediction of disease-associated outcomes by investigating the neurobiological mechanisms of underlying schizophrenia-related dysfunctions.
Detailed description
Alterations in psychosocial functioning are evident from the prodromal phase of schizophrenia and play a crucial role in its chronic course. While recent studies have demonstrated the predictive validity of structural changes in the brain anatomy of patients with schizophrenia, there is a lack of studies assessing the predictive value of disease-associated alterations in the functional brain activity for symptom severity and psychosocial functioning in schizophrenia.
In this longitudinal, observational study, 60 patients with schizophrenia and 40 healthy subjects without family history of psychotic illness will be recruited to investigate differences in behavioural, physiological, and neural correlates of social touch and interoceptive perception between participant groups. Participants' symptom severity and psychosocial functioning level will be examined by a wide range of behavioural, physiological, and neural methods. Potential biomarkers will be identified by estimating the predictive value of initially performed methods on follow-up re-examination of clinical and psychosocial outcomes. Neural readouts include structural and functional magnetic resonance imaging (fMRI) measurements. The fMRI tasks will probe the processing of social touch and interoceptive perception; additionally resting-state connectivity will be assessed. To further investigate pathological distortions of social touch and interoceptive perception, bodily touch allowance maps will be measured and participants will perform a heart-beat discrimination task. Psychometric questionnaires and semi-structured interviews will be used to capture symptom load and level of psychosocial functioning. Long-term effects will be assessed by online questionnaires and semi-structured interviews via phone call 3- and 6 months after initial assessments. The investigators hypothesize that differences in the neural response to social touch as well as in the neural patterns of interoceptive perception could serve as potential biomarkers for psychosocial deficits during the course of the illness. Furthermore, the inclusion of those biomarkers in predictive models could improve the prediction of disease progression and thus, contribute to personalized therapy.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | – | –Patients with Schizophrenia |
| Control Group | – | –Healthy subjects without family history of psychotic illness |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In- and outpatients of the Department of Psychiatry, University of Oldenburg. Patients meeting the criteria for schizophrenia or schizoaffective disorder according to DSM-V will be included in the study. The patients' diagnosis will be verified via the structured clinical interview for DSM-V. Healthy subjects without family history of psychotic illness (control group). Control group will be matched to the patient sample.
Key inclusion criteria (4 listed)
- Participant is able to provide consent.
- Diagnosis of schizophrenia or schizoaffective disorder according to DSM-V
- Control group: No psychiatric or neurological illness.
- Fluent in German.
Key exclusion criteria (4 listed)
- The participant does not fulfill requirements for MRI measurements according to safety guidelines.
- Acute suicidality.
- Current substance dependence.
- A history of head trauma or neurological illness.
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
Neural responses in a social touch task
Time frame: One-time baseline assessment
Participants will be measured with functional magnetic resonance imaging (fMRI) while they perceive different types of social and non-social touch
Behavioral responses in a social touch fMRI task
Time frame: One-time baseline assessment
Measured as behavioral ratings during the social touch fMRI task. During the social touch fMRI task, participants rate the comfort of the tactile stimuli on a visual analogue scale.
Neural responses in an interoception fMRI task
Time frame: One-time baseline assessment
Participants will be measured with functional magnetic resonance imaging (fMRI) while they perform an interoception task
Behavioral responses in an interoception fMRI task
Time frame: One-time baseline assessment
Measured by performance on the interoception task. During the interoception fMRI task, participants rate how intensely they perceived their heartbeat or their stomach on a visual analogue scale.
Changes in clinician-rated symptom severity between baseline and follow-ups
Time frame: Baseline, 3 and 6 months follow- up after initial baseline assessment
Measured by half-structured interviews (e.g. Positive and Negative Syndrome Scale (PANSS); range: 30-210; higher scores indicating more severe symptoms) for disease-related symptoms
Changes in self-reported symptom severity between baseline and follow-ups
Time frame: Baseline, 3 and 6 months follow- up after initial baseline assessment
Measured by self-evaluation questionnaires (e.g. Self-assessment of Negative Symptoms (SNS); range 1-20; higher scores indicating more severe symptoms) for disease-related symptoms
Changes in clinician-rated social-role functioning between baseline and follow-ups
Time frame: Baseline, 3 and 6 months follow- up after initial baseline assessment
Measured by the clinician-rated the social-role functioning scale (range: 1-10; higher scores indicating higher functioning)
Changes in self-reported social-role functioning levels between baseline and follow-ups
Time frame: Baseline, 3 and 6 months follow-up after initial baseline assessment
Measured by the self-evaluation questionnaires for social-role functioning (e.g. Social Network Index (SNI); range 1-12; higher scores indicating higher functioning)
8 secondary outcomes
Bodily maps of social touch
Time frame: One-time baseline assessment
Attitude towards social touch
Time frame: One-time baseline assessment
Interoceptive accuracy
Time frame: One-time baseline assessment
Interoceptive awareness
Time frame: One-time baseline assessment
Blood parameter
Time frame: One-time baseline assessment
Urine parameter
Time frame: One-time baseline assessment
Neural activity at resting state
Time frame: One-time baseline assessment
Structural connectivity measure
Time frame: One-time baseline assessment
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 9 Dec 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
René Hurlemann, Prof. principal investigator
Department of Psychiatry, University of Oldenburg
Dirk Scheele, Dr. principal investigator
Department of Psychiatry, University of Oldenburg
Danilo Postin, M.Sc. study director
Department of Psychiatry, University of Oldenburg
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 Schizophrenia, run by University of Oldenburg at 1 site in Germany.
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 4 inclusion and 4 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 9 Dec 2024. 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 Germany. 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?
Neural responses in a social touch task (time frame: One-time baseline assessment). The study lists 8 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 9 Dec 2024.