SchizophreniaNCT04655235
Translational Investigation of the Glutamatergic and GABAergic System in Schizophrenia
An observational study of Schizophrenia, run by RWTH Aachen University at 3 sites in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Genotyping
- How many people
- 600 participants
- Where
- 3 sitesGermany
- Study dates
- 1 Oct 2021to Mar 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The patients will be recruited from the Department of Psychiatry, Psychotherapy and Psychosomatics at Uniklinik RWTH Aachen, Alexianer Krankenhaus and the psychiatric institutions of Katharina Kasper ViaNobis GmbH in Gangelt. The patients will be asked whether their healthy relatives may be contacted in terms of study participation. Additionally, they will be handed the study teams' contact details. Relatives suffering from the same psychiatric disorder as the patients can also be included and will be contacted the same way as the healthy relatives. Healthy controls will be searched via notices in the Uniklinik RWTH Aachen. Furthermore, we will contact former study participants that have given their consent to being contacted for a renewed study participation.
Who may be able to join
- diagnosis of schizophrenia according to DSM-5
- aged 18 to 80
- being mentally and contractually capable to give their consent to study participation
- aged 18 to 80
- being mentally and contractually capable to give their consent to study participation
Who cannot join
- pregnancy
- structural neurological disease
- a further psychiatric comorbidity that dominates in the clinical appearance
- HEALTHY PARTICIPANTS
- pregnancy
- structural neurological disease
- psychiatric disorder
- for healthy controls: psychiatric disorders in the family history of first-degree relatives
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany3 sites, 3 recruiting
- Recruiting
Alexianer Hospital
Aachen, Northrine-Westphalia, 52062
- Recruiting
University hospital RWTH Aachen
Aachen, 52525
- Recruiting
ViaNobis - Die Fachklinik
Gangelt, Northrine-Westphalia, 52538
About this study
Official title: Translational Investigation of the Glutamatergic and GABAergic System in Schizophrenia - a Combined EEG-, FMRI-, Genetic, Serological and Cell Biological Study
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.
Read the detailed description
The participant collective will include 3 groups of 200 persons, consisting of patients with schizophrenia, their healthy relatives and healthy controls that are not related to the patients. The patients must be diagnosed of schizophrenia according to DSM-5 to be included in the study and will be excluded when there is a further psychiatric comorbidity that dominates in the clinical appearance. All participants have to be aged from 18 to 80 years, be mentally and contractually capable to give their consent to study participation and may not be pregnant or have a structural neurological disease. The healthy participants must not suffer from a psychiatric disorder themselves and, additionally, the control subjects must not have psychiatric disorders in the family history of their first-degree relatives.
Every participant will undergo the same examinations, tests and measurements. All subjects will be taken a blood sample of 30 milliliters of blood that will be tested for antibodies against the NMDA receptor, neuronal growth factors, components of the glutamatergic and GABAergic metabolism and markers for the integrity of the blood brain barrier. In addition to that, a genetic analysis to identify risk alleles for schizophrenia and important glutamatergic and GABAergic genes will be performed. A medical history of every subject will be taken, including medication, somatic and psychiatric disorders. Furthermore, a row of psychiatric ratings scales as well as neuropsychological and neurological tests will be performed.
These will include
- Structured Clinical Interview for DSM Disorders (SCID)
- Mini-RDoC
- Short Form Health 36 (SF-36)
- Personal and Social Performance Scale (PSP)
- Positive and Negative Syndrome Scale
- Berner Psychopathologie-Skala
- Calgary Depression Rating Scale for Schizophrenia
- Conners' Adult ADHD Rating Scales (CAARS)
- Wender Utah Rating Scale (WURS-k)
- Clinical Global Impression (CGI)
- Global Assessment of Functioning (GAF)
- Extrapyramidal Symptom Rating Scale (EPS)
- Heidelberg Neurological Soft Signs Scale
- Brief Assessment of Cognition in Schizophrenia
- d2 test
Every study participant must undergo an EEG measurement while different, neutral visual (fixation cross or movies without sound) and auditive stimuli (tones or clic trains) will be presented to them. They will be instructed to ignore the auditive stimuli. Resting state, auditory steady state response (ASSR) and two different auditory mismatch paradigms will be used. Without contradiction for the conduction of an MRI measurement, a combined EEG/ MRI measurement and a pure MRI measurement (without EEG) using the same paradigms are intended. It will also include structural (T1, T2 and diffusion tensor imaging) MRI and MR spectroscopy of glutamate and GABA. All the previously mentioned examinations are planned to take place on the same day with an approximate expenditure of time of five hours. If necessary, the examinations may also take place on different days, providing that there will be a maximum of three weeks between the first and the last measurement. Except from the blood withdrawal, we intend repeating all the measurements for a second time. This repetition must take place at least one day and not later than three years after the first measurement. It will not be necessary to repeat the clinical and neuropsychological tests if the first testing does not date back more than 6 weeks. In a second part of the study, we want to generate induced pluripotent stem cells (iPS cells) from 15 participants of every study group. For this purpose, a further blood sample of 20 milliliters of blood must be taken. The participants of the second part of the study will be selected based on special genetic, EEG or fMRI characteristics revealed in the first part of the study if they agree to be contacted again.
- Conditions
- Schizophrenia
- Being tested
- Genotyping
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenotypingGenetic
Genotyping of glutamatergic, GABAergic, dopaminergic and other CNS-related genes
| Study group | Role | What they receive |
|---|---|---|
| patients with schizophrenia | 200 patients with a DSM 5- diagnosis of schizophrenia Receives: Genetic: Genotyping | |
| healthy relatives of patients with schizophrenia | 200 healthy relatives of the patients with schizophrenia Receives: Genetic: Genotyping | |
| healthy control subjects | healthy control subjects without relatives with mental disorders Receives: Genetic: Genotyping |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMN
Mismatch negativity amplitude
Measured: 1 day to maximum 3 years
ASSR Power
40-Hz auditory steady state response spectral power
Measured: 1 day to maximum 3 years
Secondary outcomes (19)
ASSR Phase Locking
40-Hz auditory steady state response phase locking
Measured: 1 day to maximum 3 years
Functional connectivity
Whole brain resting state functional connectivity matrix
Measured: 1 day to maximum 3 years
Psychopathology as assessed with the PANSS
Positive and negative syndrome scale (Minimum: 30, Maximum: 210, higher scores mean worse outcome)
Measured: 1 day to maximum 3 years
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,
Measured: 1 day to maximum 3 years
Psychopathology as assessed with the CGI
Clinical Global Impression (CGI) (Minimum: 1, Maximum: 7, higher scores mean worse outcome)
Measured: 1 day to maximum 3 years
Electrophysiology
Electrophysiology assessed in iPSC derived neurons obtained from subsamples using patch clamp and microelectrode array recordings
Measured: one appointment of additional blood sampling to isolate cells for iPSC reprogramming
Expression of neural markers in iPSC derived neurons
quantitative polymerase chain reaction (qPCR), immunofluorescence, western blot
Measured: one appointment of additional blood sampling to isolate cells for iPSC reprogramming
Neurological status as assessed with the EPS
Extrapyramidal Symptom Rating Scale (Minimum: 0, Maximum: 4, higher scores mean worse outcome)
Measured: 1 day to maximum 3 years
Neurological soft signs assessed with the Heidelberg Scale
Heidelberg Neurological Soft Signs Scale (Minimum: 0, Maximum: 75, higher scores mean worse outcome)
Measured: 1 day to maximum 3 years
Psychopathology as assessed with the SCID
Structured Clinical Interview for DSM Disorders (SCID)
Measured: 1 day to maximum 3 years
Psychopathology as assessed with the Mini-RDoC
Minimum data set Research Domain Criteria
Measured: 1 day to maximum 3 years
Psychopathology as assessed with the SF-36
Short Form Health (Minimum: 0, Maximum: 100, higher scores mean better outcome)
Measured: 1 day to maximum 3 years
Psychopathology as assessed with the PSP
Personal and Social Performance Scale (Minimum: 1, Maximum: 100, higher scores mean better outcome)
Measured: 1 day to maximum 3 years
Psychopathology as assessed with the CDSS
Calgary Depression Rating Scale for Schizophrenia (Minimum: 0, Maximum: 27, higher scores mean worse outcome)
Measured: 1 day to maximum 3 years
Psychopathology as assessed with the CAARS (Minimum: 0, Maximum: 198, higher scores mean worse outcome)
Conners' Adult ADHD Rating Scales
Measured: 1 day to maximum 3 years
Psychopathology as assessed with the WURS-k (Minimum: 0, Maximum: 84, higher scores mean worse outcome)
Wender Utah Rating Scale
Measured: 1 day to maximum 3 years
Psychopathology as assessed with the GAF
Global Assessment of Functioning
Measured: 1 day to maximum 3 years
Neuropsychology assessed with BACS
Brief Assessment of Cognition in Schizophrenia
Measured: 1 day to maximum 3 years
Neuropsychology assessed with d2 test
d2 test
Measured: 1 day to maximum 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2020
- Study start1 Oct 2021
- Primary completionDec 2028 (estimated)
- Study completionMar 2030 (estimated)
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
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arnim Gaebler, RWTH Aachen University
- Investigators
- Arnim Gaebler, M.D., Principal investigator, Uniklinik RWTH Aachen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655235
- Sponsor's protocol ID
- 19-201
- Status last verified
- Mar 2025
- First submitted
- 28 Nov 2020
- Last updated
- 14 Mar 2025
- 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 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Translational Investigation of the Glutamatergic and GABAergic System in Schizophrenia - a Combined EEG-, FMRI-, Genetic, Serological and Cell Biological Study
- ClinicalTrials.gov ID
- NCT04655235
- Acronym / sponsor ID
- 19-201
- Conditions
- Schizophrenia
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2030 (estimated)
- First posted
- 7 Dec 2020 (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.
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.
Detailed description
The participant collective will include 3 groups of 200 persons, consisting of patients with schizophrenia, their healthy relatives and healthy controls that are not related to the patients. The patients must be diagnosed of schizophrenia according to DSM-5 to be included in the study and will be excluded when there is a further psychiatric comorbidity that dominates in the clinical appearance. All participants have to be aged from 18 to 80 years, be mentally and contractually capable to give their consent to study participation and may not be pregnant or have a structural neurological disease. The healthy participants must not suffer from a psychiatric disorder themselves and, additionally, the control subjects must not have psychiatric disorders in the family history of their first-degree relatives.
Every participant will undergo the same examinations, tests and measurements. All subjects will be taken a blood sample of 30 milliliters of blood that will be tested for antibodies against the NMDA receptor, neuronal growth factors, components of the glutamatergic and GABAergic metabolism and markers for the integrity of the blood brain barrier. In addition to that, a genetic analysis to identify risk alleles for schizophrenia and important glutamatergic and GABAergic genes will be performed. A medical history of every subject will be taken, including medication, somatic and psychiatric disorders. Furthermore, a row of psychiatric ratings scales as well as neuropsychological and neurological tests will be performed.
These will include
- Structured Clinical Interview for DSM Disorders (SCID)
- Mini-RDoC
- Short Form Health 36 (SF-36)
- Personal and Social Performance Scale (PSP)
- Positive and Negative Syndrome Scale
- Berner Psychopathologie-Skala
- Calgary Depression Rating Scale for Schizophrenia
- Conners' Adult ADHD Rating Scales (CAARS)
- Wender Utah Rating Scale (WURS-k)
- Clinical Global Impression (CGI)
- Global Assessment of Functioning (GAF)
- Extrapyramidal Symptom Rating Scale (EPS)
- Heidelberg Neurological Soft Signs Scale
- Brief Assessment of Cognition in Schizophrenia
- d2 test
Every study participant must undergo an EEG measurement while different, neutral visual (fixation cross or movies without sound) and auditive stimuli (tones or clic trains) will be presented to them. They will be instructed to ignore the auditive stimuli. Resting state, auditory steady state response (ASSR) and two different auditory mismatch paradigms will be used. Without contradiction for the conduction of an MRI measurement, a combined EEG/ MRI measurement and a pure MRI measurement (without EEG) using the same paradigms are intended. It will also include structural (T1, T2 and diffusion tensor imaging) MRI and MR spectroscopy of glutamate and GABA. All the previously mentioned examinations are planned to take place on the same day with an approximate expenditure of time of five hours. If necessary, the examinations may also take place on different days, providing that there will be a maximum of three weeks between the first and the last measurement. Except from the blood withdrawal, we intend repeating all the measurements for a second time. This repetition must take place at least one day and not later than three years after the first measurement. It will not be necessary to repeat the clinical and neuropsychological tests if the first testing does not date back more than 6 weeks. In a second part of the study, we want to generate induced pluripotent stem cells (iPS cells) from 15 participants of every study group. For this purpose, a further blood sample of 20 milliliters of blood must be taken. The participants of the second part of the study will be selected based on special genetic, EEG or fMRI characteristics revealed in the first part of the study if they agree to be contacted again.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patients with schizophrenia | – | Genetic: Genotyping200 patients with a DSM 5- diagnosis of schizophrenia |
| healthy relatives of patients with schizophrenia | – | Genetic: Genotyping200 healthy relatives of the patients with schizophrenia |
| healthy control subjects | – | Genetic: Genotypinghealthy control subjects without relatives with mental disorders |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The patients will be recruited from the Department of Psychiatry, Psychotherapy and Psychosomatics at Uniklinik RWTH Aachen, Alexianer Krankenhaus and the psychiatric institutions of Katharina Kasper ViaNobis GmbH in Gangelt. The patients will be asked whether their healthy relatives may be contacted in terms of study participation. Additionally, they will be handed the study teams' contact details. Relatives suffering from the same psychiatric disorder as the patients can also be included and will be contacted the same way as the healthy relatives. Healthy controls will be searched via notices in the Uniklinik RWTH Aachen. Furthermore, we will contact former study participants that have given their consent to being contacted for a renewed study participation.
Key inclusion criteria (5 listed)
- diagnosis of schizophrenia according to DSM-5
- aged 18 to 80
- being mentally and contractually capable to give their consent to study participation
- aged 18 to 80
- being mentally and contractually capable to give their consent to study participation
Key exclusion criteria (8 listed)
- pregnancy
- structural neurological disease
- a further psychiatric comorbidity that dominates in the clinical appearance
- HEALTHY PARTICIPANTS
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenotypingGenotyping of glutamatergic, GABAergic, dopaminergic and other CNS-related genes | Genetic | healthy control subjects, healthy relatives of patients with schizophrenia, patients with schizophrenia |
Primary outcome
MMN
Time frame: 1 day to maximum 3 years
Mismatch negativity amplitude
ASSR Power
Time frame: 1 day to maximum 3 years
40-Hz auditory steady state response spectral power
19 secondary outcomes
ASSR Phase Locking
Time frame: 1 day to maximum 3 years
Functional connectivity
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the PANSS
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the BPP
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the CGI
Time frame: 1 day to maximum 3 years
Electrophysiology
Time frame: one appointment of additional blood sampling to isolate cells for iPSC reprogramming
Expression of neural markers in iPSC derived neurons
Time frame: one appointment of additional blood sampling to isolate cells for iPSC reprogramming
Neurological status as assessed with the EPS
Time frame: 1 day to maximum 3 years
Neurological soft signs assessed with the Heidelberg Scale
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the SCID
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the Mini-RDoC
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the SF-36
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the PSP
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the CDSS
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the CAARS (Minimum: 0, Maximum: 198, higher scores mean worse outcome)
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the WURS-k (Minimum: 0, Maximum: 84, higher scores mean worse outcome)
Time frame: 1 day to maximum 3 years
Psychopathology as assessed with the GAF
Time frame: 1 day to maximum 3 years
Neuropsychology assessed with BACS
Time frame: 1 day to maximum 3 years
Neuropsychology assessed with d2 test
Time frame: 1 day to maximum 3 years
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 14 Mar 2025.
- 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.
Arnim Gaebler, M.D. principal investigator
Uniklinik RWTH Aachen
3 sites 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 RWTH Aachen University at 3 sites 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 5 inclusion and 8 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Arnim Gaebler, M.D. (+49 241 800, agaebler@ukaachen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MMN (time frame: 1 day to maximum 3 years). The study lists 2 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 14 Mar 2025.