Trial document




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  DRKS00004756

Trial Description

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Title

The effect of stimulus patterns on the mismatch negativity in patients with schizophrenia

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Trial Acronym

Predict

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URL of the Trial

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Brief Summary in Lay Language

Previous studies revealed that the auditory stimulus processing differs in people with schizophrenia. This study is intended to contribute to the question to what extend the perception of regular versus irregular tone pattern differ between patients with schizophrenia and healthy subjects. We use electroencephalography (EEG) to measure auditory processing. Furthermore we aim to explore if auditory processing is associated with schizophrenia symptoms or cognitive abilities. This is measured with questionnaires and interviews on clinical symptoms. It is expected that patients with schizophrenia show a lower ability detect regularity in variations in tone durations as compared to healthy controls . Futhermore we expect that the amount of processing to the auditory stimuli is associated with cognitive abilities in tasks on attention and memory. The study will include 30 patients with a diagnosis of schizophrenia and 30 healthy control subjects in the age range of 18 to 55 years.

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Brief Summary in Scientific Language

Many studies reported that the mismatch negativity (MMN) – an index of auditory information processing - is impaired in patients with schizophrenia. The current study examines whether the predictability of duration deviant stimulus events affect MMN amplitudes. It is expected that patients with schizophrenia show lower MMN amplitudes in general and they dont show an attentuation of the MMN with preditable stimulus duration deviance patterns which can be expected in healthy control subjects. This is examined in four conditions with two different interstimulus intervals. Additionally we will assess associations between MMN amplitudes and measures of clinical symptoms and cognitive abilities as measured by attention and memory tasks.

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Organizational Data

  •   DRKS00004756
  •   2013/02/26
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  •   yes
  •   Approved
  •   12-5246-BO, Ethik-Kommission der Medizinischen Fakultät der Universität Duisburg-Essen
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Secondary IDs

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Health Condition or Problem studied

  •   F20 -  Schizophrenia
  •   F25 -  Schizoaffective disorders
  •   F22 -  Persistent delusional disorders
  •   DSM-IV 295.30 Schizophrenia, paranoid type
  •   DSM-IV 295.10 Schizophrenia, disorganized type
  •   DSM-IV 295.90 Schizophrenia, undifferentiated type
  •   DSM-IV 295.60 Schizophrenia, residual type
  •   DSM-IV 295.40 Schizophreniform disorder
  •   DSM-IV 295.70 Schizoaffective disorder
  •   DSM-IV 297.1 Delusional disorder
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Interventions/Observational Groups

  •   Patients: A electrophysiological and clinical measurement (SKID, PANSS) are used. Futhermore we conduct neuopsychological tests (MWT-B, ZST, SKT, TMT A/B, WMS-R). The electrophysiological measurement will take about 40 minutes. The subjects listen to tone pattern while watching a nature film.
  •   healthy controls: A electrophysiological and clinical measurement (DIPS) are used. Futhermore we conduct neuopsychological tests (MWT-B, ZST, SKT, TMT A/B, WMS-R). The electrophysiological measurement will take about 40 minutes. The subjects listen to tone pattern while watching a nature film.
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
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  •   Other
  •   Basic research/physiological study
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Primary outcome is the amplitude of the mismatch negativity in the lantency range of 120 ms to 260 ms following stimulus onset

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Secondary Outcome

Secondary outcome is the performance in study participants in the neuropsychological assessment and the expression of clinical symptoms as assessed with the Positive and Negative Syndrome Scale (PANSS). Neuropsychological assessments include: The German Merfachwahl Wortschatz Test (MWT-B), the Digit Symbol Test (ZST), Syndrome short Test (SKT) and the Trail Making Test Part A +B (TMT A/B).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2013/03/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   55   Years
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Additional Inclusion Criteria

Patients: DSM-IV Schizophrenia diagnosis: 295.30, 295.10, 295.9, 295.60, 295.40, 295.70, 297.1;
Patients: stable medication since two weeks;
healthy controls: no psychiatric disorder (for example a major depression);
MWT-B IQ > 75;
fluency of German language;
voluntary written consent

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Exclusion Criteria

Impaired hearing;
neurological or neurodegenerative disorder,
persisting or past substance abuse;
acut or chronic inflammatory disease of the nervous system, other serious physical diseases or
malignant tumors

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Addresses

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    • Klinik für Psychiatrie und Psychotherapie, LVR-Klinikum Essen, Universität Duisburg Essen
    • Mr.  PD Dr. phil.  Bernhard W.  Müller 
    • Virchowstraße 174
    • 45147  Essen
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie, LVR-Klinikum Essen, Klinik der Universität Duisburg-Essen
    • Mr.  PD Dr. phil.  Bernhard  Müller 
    • Virchowstrasse 147
    • 45174  Essen
    • Germany
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    • Klinik für Psychiatrie und Psychotherapie, LVR-Klinikum Essen, Universität Duisburg-Essen
    • Ms.  B.Sc.  Magdalena  Breitkopf 
    • Virchowstrasse 174
    • 45147  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Psychiatrie und Psychotherapie, LVR-Klinikum Essen, Klinik der Universität Duisburg-Essen
    • Mr.  Prof. Dr. med.  Jens  Wiltfang 
    • Virchowstrasse 147
    • 45174  Essen
    • Germany
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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