Trial document




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  DRKS00004880

Trial Description

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Title

Catamnestic examination of the relationship between cognitive performance and time to relapse in patients suffering from schizophrenia

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Many schizophrenia patients also suffer from cognitive problems. For example, attention, memory and the ability to plan complex matters may be impaired. While this directly affects coping in with problems in everyday life, is not clear yet whether poorer cognitive functioning may even negatively affect the course of disease. For this reason, time to any inpatient readmissions in 60 patients who participated in a study on cognitive training a few years ago will be determined. It is expected that poorer performance in neuropsychological tests may result in earlier and more frequent readmissions. Additionally it will be examined whether other characteristics, such as age, duration of disease or number of previous episodes are related to readmissions.

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Brief Summary in Scientific Language

Schizophrenia patients suffer from robust (Cohen's d effect sizes> 1.0 in current meta-analyses) deficits in (working) memory, attention and problem solving. It has been shown in many studies that these deficits affect everyday functioning. Clinical studies adressing the impact on the course of the disease are rare. By now, only very few studies examined associations of neurocognitive performance to measures like ‘time in psychosis’ or ‘time to first relapse’. Unfortunately, those that discovered significant relationships considered shorter follow-up intervals and, maybe because of this, utilized weaker measures like ‘clinical deterioration’ as criterion for clinical outcome. In the present study, for 60 patients who participated in a study on cognitive remediation a few years ago and for whom detailed data on neuropsychological performance was collected, the further course will be determined retrospectively. Significantly increased relative risks for those patients for whom a worse cognitive performance level could be diagnosed are expected. In an exploratory manner, it will be examined whether other features, such as age, duration of disease or the number of previous schizophrenic episodes also are related with the risk of earlier and more frequent readmissions.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00004880
  •   2013/04/17
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  •   yes
  •   Approved
  •   keine Nummer vergeben, Ethikrat der Otto-Friedrich-Universität Bamberg
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Secondary IDs

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Health Condition or Problem studied

  •   F20 -  Schizophrenia
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Interventions/Observational Groups

  •   time until relapse as well as number of episodes after completion of the cognitive remediation study and additionally partnership, years of education, employment status, time since onset of illness, habitation status and antipsychotic medication will be determined retrospectively from the medical records
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Single blind
  •   assessor
  •   Uncontrolled/Single arm
  •   Prognosis
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Time to rehospitalisation

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Secondary Outcome

Number of rehospitalisations

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • Medical Center 
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Recruitment

  •   Planned
  •   2013/05/01
  •   60
  •   Monocenter trial
  •   National
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Inclusion Criteria

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

Diagnosis of schizophrenia, IQ above 85
participation in the cognitive remediation study,
availability neuropsychological test score ​​from the participation in the study

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Exclusion Criteria

IQ < 85, other psychiatric disorders

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Addresses

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    • Sozialstiftung Bamberg Klinik für Psychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Dr.  Wolfgang  Trapp 
    • St. Getreu-Str. 18
    • 96049  Bamberg
    • Germany
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    • Sozialstiftung Bamberg Klinik für Psychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Dr.  Wolfgang  Trapp 
    • St. Getreu-Str. 18
    • 96049  Bamberg
    • Germany
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    • Sozialstiftung Bamberg Klinik für Psychiatrie, Psychotherapie und Psychosomatik
    • Mr.  Dr.  Wolfgang  Trapp 
    • St. Getreu-Str. 18
    • 96049  Bamberg
    • Germany
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Sources of Monetary or Material Support

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    • Sozialstiftung Bamberg Klinik für Psychiatrie, Psychosomatik und Psychotherapie
    • St.-Getreu-Straße 18
    • 96049  Bamberg
    • Germany
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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