Schizophrenia Clinical Trial
Official title:
Translational Investigation of the Glutamatergic and GABAergic System in Schizophrenia - a Combined EEG-, fMRI-, Genetic, Serological and Cell Biological Study
NCT number | NCT04655235 |
Other study ID # | 19-201 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2022 |
Est. completion date | March 2030 |
In the last years, the imbalance between excitatory and inhibitory neuronal activity has come to the fore as a possible molecular disease mechanism of schizophrenia . Pharmacological studies have suggested different fMRI and EEG markers of that molecular dysfunction (resting state connectivity changes, auditory mismatch and steady state deficits). However, previous research is inconclusive regarding their genetic basis, their reliability, inter-individual relationship as well as disease specificity. Therefore, in this study we aim at estimating the effect sizes, test-retest-reliability and clinical correlates of the respective markers in a comparative fashion in patients with schizophrenia, their relatives and healthy control subject. To assess their molecular validity, we will assess their relationship with glutamatergic and GABAergic genotypes and cellular disease models. The proof of such a relation would give the opportunity of detecting a glutamatergic and GABAergic imbalance throughout non-invasive imaging. Furthermore, it would help deepening our understanding of the molecular pathophysiology of mental disorders which will be essential for the development of more effective drugs.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | March 2030 |
Est. primary completion date | December 2028 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | PATIENTS Inclusion Criteria: - diagnosis of schizophrenia according to DSM-5 - aged 18 to 80 - being mentally and contractually capable to give their consent to study participation Exclusion Criteria: - pregnancy - structural neurological disease - a further psychiatric comorbidity that dominates in the clinical appearance HEALTHY PARTICIPANTS Inclusion Criteria: - aged 18 to 80 - being mentally and contractually capable to give their consent to study participation Exclusion Criteria: - pregnancy - structural neurological disease - psychiatric disorder - for healthy controls: psychiatric disorders in the family history of first-degree relatives |
Country | Name | City | State |
---|---|---|---|
Germany | Alexianer Hospital | Aachen | Northrine-Westphalia |
Germany | University hospital RWTH Aachen | Aachen | |
Germany | ViaNobis - Die Fachklinik | Gangelt | Northrine-Westphalia |
Lead Sponsor | Collaborator |
---|---|
RWTH Aachen University |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MMN | Mismatch negativity amplitude | 1 day to maximum 3 years | |
Primary | ASSR Power | 40-Hz auditory steady state response spectral power | 1 day to maximum 3 years | |
Secondary | ASSR Phase Locking | 40-Hz auditory steady state response phase locking | 1 day to maximum 3 years | |
Secondary | Functional connectivity | Whole brain resting state functional connectivity matrix | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the PANSS | Positive and negative syndrome scale (Minimum: 30, Maximum: 210, higher scores mean worse outcome) | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the BPP | Berner Psychopathologie-Skala (Minimum: -3, Maximum: +3, higher positive scores mean excessive speech, movements or higher positive affect, higher negative scores mean a lack of speech, movements or higher negative affect, | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the CGI | Clinical Global Impression (CGI) (Minimum: 1, Maximum: 7, higher scores mean worse outcome) | 1 day to maximum 3 years | |
Secondary | Electrophysiology | Electrophysiology assessed in iPSC derived neurons obtained from subsamples using patch clamp and microelectrode array recordings | one appointment of additional blood sampling to isolate cells for iPSC reprogramming | |
Secondary | Expression of neural markers in iPSC derived neurons | quantitative polymerase chain reaction (qPCR), immunofluorescence, western blot | one appointment of additional blood sampling to isolate cells for iPSC reprogramming | |
Secondary | Neurological status as assessed with the EPS | Extrapyramidal Symptom Rating Scale (Minimum: 0, Maximum: 4, higher scores mean worse outcome) | 1 day to maximum 3 years | |
Secondary | Neurological soft signs assessed with the Heidelberg Scale | Heidelberg Neurological Soft Signs Scale (Minimum: 0, Maximum: 75, higher scores mean worse outcome) | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the SCID | Structured Clinical Interview for DSM Disorders (SCID) | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the Mini-RDoC | Minimum data set Research Domain Criteria | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the SF-36 | Short Form Health (Minimum: 0, Maximum: 100, higher scores mean better outcome) | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the PSP | Personal and Social Performance Scale (Minimum: 1, Maximum: 100, higher scores mean better outcome) | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the CDSS | Calgary Depression Rating Scale for Schizophrenia (Minimum: 0, Maximum: 27, higher scores mean worse outcome) | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the CAARS (Minimum: 0, Maximum: 198, higher scores mean worse outcome) | Conners' Adult ADHD Rating Scales | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the WURS-k (Minimum: 0, Maximum: 84, higher scores mean worse outcome) | Wender Utah Rating Scale | 1 day to maximum 3 years | |
Secondary | Psychopathology as assessed with the GAF | Global Assessment of Functioning | 1 day to maximum 3 years | |
Secondary | Neuropsychology assessed with BACS | Brief Assessment of Cognition in Schizophrenia | 1 day to maximum 3 years | |
Secondary | Neuropsychology assessed with d2 test | d2 test | 1 day to maximum 3 years |
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