Trial document




drksid header

  DRKS00000101

Trial Description

start of 1:1-Block title

Title

Treatment of Childhood and Adolescent Anorexia Nervosa - A Comparison of a Day treatment and an Inpatient Treatment Setting

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ANDI

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://www.was-ist-magersucht.de

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

It`s the aim of the study to compare inpatient setting with day-patient setting in the treatment of adolescent anorexia nervosa.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

To assess by means of a multi-centre randomized controlled study if day patient treatment following a three-week inpatient stabilisation phase in non-chronic adolescent anorexia nervosa (AN) is not different (non-inferior) from inpatient treatment of the same length in terms of amount of weight gain after one year.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000101
  •   2009/03/17
  •   2007/01/18
  •   yes
  •   Approved
  •   127/06, Ethik-Kommission an der Medizinischen Fakultät der RWTH Aachen
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   ISRCTN67783402  (Current Controlled Trials)
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   F50.0 -  Anorexia nervosa
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   inpatient treatment: 24 hours inpatient setting, treatment modules like in day-patient-setting
  •   day-patient-setting: time spent in hospital 8-9 hours. treatment modules like in setting 1
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control
  •   Treatment
  •   Other
  •   [---]*
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

difference of the BMI at admission compared to 52nd-weeks after admission; additional follow up: difference of the BMI at admission compared to 130th-weeks after admission

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

descriptive measures of psychopathology including specific eating disorder psychopathology (Eating Disorders Inventory-II, EDI-II, Morgan-Russell Outcome Assessment Schedule and Structured Inventory for Anorexia and Bulimia nervosa - Expert version, SIAB-EX), depressive (Beck Depressions Inventory - II, BDI-II), anxiety (Spencer's-Children-Anxiety-Scale, SCAS-D and "Sozialphobie- und Angstinventar für Kinder", SPAIK) and obsessive-compulsive symptoms (Children`s-Yale-Brown-Obsessive-Compulsive-Scale, CY-BOCS), burden of parents (Brief Symptom Inventory, BSI and Beck Depression Inventory - II, BDI-II), expressed emotions (Familienfragebogen, FFB) and at 1-year after admission as well as 2,5 years after admission the number of relapses (rehospitalisation) and quality of life (Inventar zur Erfassung der Lebensqualität, ILK). In addition the number of days till achievement of body weight in both settings was counted and all patients were followed up regarding weight loss and potential relapses

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2007/03/08
  •   170
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   11   Years
  •   18   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

DSM-IV criteria of AN according to DSM-IV, first admission to hospital treatment for AN, IQ > 85, age 11-18 years, sufficient knowledge of the German language, informed consent of patient and parents

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

Psychotic or severe personality disorders, serious self-injury, substance abuse, serious medical condition, suicidal ideation

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Rektor der RWTH Aachen
    • Mr.  Prof. Dr.  Burkart  Rauhut 
    • Templergraben 55
    • 52062  Aachen
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   0241 80 94000
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • KJPP der RWTH Aachen
    • Ms.  Prof. Dr. med.  Beate  Herpertz-Dahlmann 
    • Neuenhofer Weg 21
    • 52074  Aachen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • KJPP der RWTH Aachen
    • Ms.  Reinhild  Schwarte 
    • Neuenhofer Weg 21
    • 52074  Aachen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bundesministerium für Bildung und Forschung
    • Ms.  Steinhausen 
    • Heinemannstr. 2
    • 53175  Bonn
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    •   0)228/ 9957-0
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2012/10/18
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.