Department of Psychiatry, University of Oldenburg
Bad Zwischenahn, 26160, Germany
NCT Number: NCT04968223
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.
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Notify Me18 year–65 year
All sexes
Observational
Bad Zwischenahn, 26160, Germany
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: One-time baseline assessment
Participants will be measured with functional magnetic resonance imaging (fMRI) while they perform an interoception 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.
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
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
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)
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)
Time frame: One-time baseline assessment
Measured as performance on a bodily maps computer task
Time frame: One-time baseline assessment
Measured by the self-evaluation questionnaire for social touch tolerance (e.g. Social Touch Questionnaire; range 0-4; higher scores indicating higher touch tolerance)
Time frame: One-time baseline assessment
Measured as performance on a heartbeat discrimination task
Time frame: One-time baseline assessment
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)
Time frame: One-time baseline assessment
Measured by schizophrenia related, Nuclear Magnetic Resonance spectroscopy (NMR) based metabolomics
Time frame: One-time baseline assessment
Measured by schizophrenia related, Nuclear Magnetic Resonance spectroscopy (NMR) based metabolomics
Time frame: One-time baseline assessment
fMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open.
Time frame: One-time baseline assessment
fMRI will be performed to measure BOLD-signal while participants lay in the MRI-scanner with eyes open.
University of Oldenburg
Other
Acronym: SPIRIT
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