Trial document





This trial has been registered retrospectively.
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  DRKS00008558

Trial Description

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Title

Follow-up investigation of patients of a rehabilitation center (Leppermühle) with the diagnosis of schizophrenia spectrum disorder

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Trial Acronym

Leppermühle Follow-Up

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URL of the Trial

[---]*

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Brief Summary in Lay Language

Schizophrenic psychoses go along with the most serious psychiatric disorders in child and adolescent psychiatry with substantial risks for chronic manifestation.
Up to now there are only little clinical trials concerning the course or the outcome for schizophrenic psychoses with onset in childhood and adolescence that show poorer prognosis and poorer outcome in contrast to schizophrenia with onset in adulthood. (Remschmid & Theisen, 2005 & 2012). In a study of the team of Freiburg among Prof. Christian Fleischhaker there was a relatively positive course compared to other studies concerning the psycho-social performance level. (Fleischhaker et al. 2005, Bihlmaier, 2008). This relatively positive course was associated with a consistent therapy and an intensive use of rehabilitation services. These rehabilitation services are performed in Germany as inpatient rehabilitation according to the “Kinder- und Jugendhilfegesetz (KJHG) in specialized educational-therapeutic institutions of the youth welfare service. For these specialized youth welfare services respectively “rehabilitation services” until now there were no longitudinal studies though the costs are continuously rising. There is an urgent public interest for the evaluation of the effectiveness of such inpatient educational therapeutic rehabilitation services, because there are considerable costs and inpatients often stay one to three years in such institutions (An inpatient in such a “rehabilitation”, in this case using the example of an external residential community of the Leppermühle, costs 60524,30 Euros per year with a daily rate of 165,82 Euros).
Objective of the present study is to explore the course prospectively of 50 children and adolescents suffering from a schizophrenic psychosis and who are currently treated in the residential community for children and adolescents Leppermühle in Buseck.
The residential community for children and adolescents Leppermühle in Buseck currently is the largest institution of this type that offers an inpatient rehabilitation service for these seriously ill children and adolescents with an experience of more than three decades in Germany.
All children and adolescents with schizophrenic or schizoaffective psychosis diagnosed according to ICD-10 criteria are included that were treated in the Leppermühle in the last year.
The follow-up takes place in a clinical investigation to record the psycho-social development, the quality of life and the current psychopathology and psychopharmacology. In addition, known predictors of the long-term course of schizophrenic disorders are to be validated and reviewed in the clinical life. (Fleischhaker et al. 2005).
In a second part several neuropsychological and electrophysiological investigations are to be conducted and evaluated as further predictors for the long-term course of schizophrenic disorders.

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Brief Summary in Scientific Language

Follow-up investigation of patients of a rehabilitation center (Leppermühle) with the diagnosis of adolescent schizophrenia

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Organizational Data

  •   DRKS00008558
  •   2015/06/29
  •   [---]*
  •   yes
  •   Approved
  •   104/15, Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   F20 -  Schizophrenia
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Interventions/Observational Groups

  •   Examination at the beginning and course of schizophrenic psychosis with IRAOS ("Interview for the Retrospective Assessment of the Onset and Course of Schizophrenia and other Psychoses"). Investigation of the functioning level with CGI/GAF ("Clinical Global Impressions", "Global Assessment of Functioning Scale") and GAS ("Global Assessment Scale"). Investigation of symptomatology with SAPS/SANS ("Scale for the Assessment of Positive/Negative Symptoms"), BPRS ("Brief Psychiatric Rating Scale") and BSCL ("Brief Symptom Checklist"). Investigation of the Life quality with ILK ("Instrument for assessing quality of life in children"). Investigation of treatment satisfaction with FBB ("Questionnaire for the evaluation of treatment"). Neuropsychological examination with WAIS-IV ("Wechsler Adult Intelligence Scale - Fourth Edition", short form) and TMT A/-B ("Trail Making Test" form A and B).

    The investigation inventory will be raised at the beginning of the integration measure in the Leppermühle (T0) and again after one-year (T1).
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Characteristics

  •   Non-interventional
  •   Other
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

Examination at the beginning and course of schizophrenic psychosis with IRAOS ("Interview for the Retrospective Assessment of the Onset and Course of Schizophrenia and other Psychoses"). Investigation of the functioning level with CGI/GAF ("Clinical Global Impressions", "Global Assessment of Functioning Scale") and GAS ("Global Assessment Scale"). Investigation of symptomatology with SAPS/SANS ("Scale for the Assessment of Positive/Negative Symptoms"), BPRS ("Brief Psychiatric Rating Scale").

The investigation inventory will be raised at the beginning of the integration measure in the Leppermühle (T0) and again after one-year (T1).

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Secondary Outcome

Investigation of the symptomatology with BSCL ("Brief Symptom Checklist"). Investigation of the Life quality with ILK ("Instrument for assessing quality of life in children"). Investigation of treatment satisfaction with FBB ("Questionnaire for the evaluation of treatment"). Neuropsychological examination with WAIS-IV ("Wechsler Adult Intelligence Scale - Fourth Edition", short form) and TMT A/-B ("Trail Making Test" form A and B).

The investigation inventory will be raised at the beginning of the integration measure in the Leppermühle (T0) and again after one-year (T1).

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • other 
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Recruitment

  •   Actual
  •   2015/05/05
  •   50
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   8   Years
  •   21   Years
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Additional Inclusion Criteria

All children and adolescents treated in the Leppermühle/Buseck suffering from a schizophrenic psychosis are to be included in this follow up.

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Exclusion Criteria

Diagnosis of exclusion: F20.6. Simple schizophrenia because the reliability and validity of this diagnosis is highly controversial.

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Addresses

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    • Universitätsklinikum Freiburg, Zentrum für psychische Erkrankungen, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter
    • Hauptstrasse 8
    • 79104  Freiburg
    • Germany
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    • Kinder-und Jugendwohnheim Leppermühle
    • Mr.  PD Dr.  Mathias  Martin 
    • Leppermühle 2
    • 35447 
    • Germany
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    • Zentrum für psychische Erkrankungen Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter
    • Mr.  Prof. Dr.  Christian  Fleischhaker 
    • Hauptstraße 8
    • 79104  Freiburg
    • Germany
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    • Kinder- und Jugendwohnheim Leppermühle,
    • Ms.  Dipl.-Psych  Anne  Burgbacher 
    • Leppermühle 1
    • 35418  Buseck
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Freiburg, Zentrum für psychische Erkrankungen, Klinik für Psychiatrie, Psychotherapie und Psychosomatik im Kindes- und Jugendalter
    • Hauptstrasse 8
    • 79104  Freiburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.