Translational Investigation of the Glutamatergic and GABAergic System in Schizophrenia

ConditionSchizophrenia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorRWTH Aachen University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

diagnosis of schizophrenia according to DSM-5

aged 18 to 80

being mentally and contractually capable to give their consent to study participation

Disqualifiers

pregnancy

structural neurological disease

a further psychiatric comorbidity that dominates in the clinical appearance

aged 18 to 80

Trial 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Genotyping

    Genetic

    Genotyping of glutamatergic, GABAergic, dopaminergic and other CNS-related genes

Treatment groups

600 Participants
are divided into 3 treatment groups
Group A: patients with schizophrenia1 intervention
Group B: healthy relatives of patients with schizophrenia1 intervention
Group C: healthy control subjects1 intervention

Trial outcomes

Primary outcomes

1

MMN

Mismatch negativity amplitude

Time frame
1 day to maximum 3 years
2

ASSR Power

40-Hz auditory steady state response spectral power

Time frame
1 day to maximum 3 years

Secondary outcomes

1

ASSR Phase Locking

40-Hz auditory steady state response phase locking

Time frame
1 day to maximum 3 years
2

Functional connectivity

Whole brain resting state functional connectivity matrix

Time frame
1 day to maximum 3 years
3

Psychopathology as assessed with the PANSS

Positive and negative syndrome scale (Minimum: 30, Maximum: 210, higher scores mean worse outcome)

Time frame
1 day to maximum 3 years
4

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,

Time frame
1 day to maximum 3 years

Other outcomes

Sponsors and contacts

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