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Effects and mechanisms of psychotherapy in the treatment of attention deficit hyperactivity disorder in adults: the first randomised multicentre study
ISRCTN ISRCTN54096201
DOI 10.1186/ISRCTN54096201
ClinicalTrials.gov identifier
EudraCT number 2006-000222-31
Public title Effects and mechanisms of psychotherapy in the treatment of attention deficit hyperactivity disorder in adults: the first randomised multicentre study
Scientific title
Acronym N/A
Serial number at source Code: 070170
Study hypothesis 1. A disorder specific psychotherapy is more effective in reducing symptoms of adult Attention Deficit Hyperactivity Disorder (ADHD) than a control condition in terms of clinical management
2. The combination of a disorder specific psychotherapy and medication is superior to medication or psychotherapy alone
Lay summary Not provided at time of registration
Ethics approval Approval received from the local ethics committee (Ethik-Kommission der Albert-Ludwigs-Universität Freiburg) on the 19th October 2006 (ref: 217/06).
Study design Controlled randomised multicentre trial
Countries of recruitment Germany
Disease/condition/study domain Attention Deficit Hyperactivity Disorder (ADHD)
Participants - inclusion criteria ADHD according to the Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) criteria
Participants - exclusion criteria 1. Mental handicap
2. Schizophrenia
3. Bipolar disorder
4. Suicidal behaviour
5. Substance abuse/dependence within six months prior to screening
6. Neurological diseases
7. Seizures
Anticipated start date 01/11/2006
Anticipated end date 31/10/2011
Status of trial Completed
Patient information material
Target number of participants 448
Interventions Experimental intervention:
1. Psychotherapy following a weekly structured group-program for 12 weeks (according to Hesslinger et. al.) and placebo and after that monthly group sessions and placebo
2. Psychotherapy (see point one) and medication (methylphenidate, according to the German guidelines for adult ADHD)

Control intervention:
3. Medication alone with clinical management weekly for the first 12 weeks and monthly thereafter
4. Placebo alone with clinical management weekly for the first 12 weeks and monthly thereafter
Primary outcome measure(s) Conners Adult ADHD Rating Scale (CAARS-O, blind-observer rated).
Secondary outcome measure(s) 1. Conners Adult ADHD Rating Scale (CAARS-S, patient rated)
2. Symptoms CheckList (SCL-90-R)
3. Depression
4. Clinical Global Impression (CGI)
5. Quality of Life
Sources of funding German Federal Ministry of Research and Education (Bundesministerium für Bildung und Forschung [BMBF]) (Germany)
Trial website
Publications 2010 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21432607
2013 enrollment and characteristics of the study sample in: http://www.ncbi.nlm.nih.gov/pubmed/24132867
Contact name Dr  Alexandra  Philipsen
  Address Hauptstrasse 5
  City/town Freiburg
  Zip/Postcode D-79104
  Country Germany
Sponsor University of Freiburg Medical School (Germany)
  Address Hauptstrasse 5
  City/town Freiburg
  Zip/Postcode D-79104
  Country Germany
  Sponsor website: http://www.uniklinik-freiburg.de/ims/live/index_en.html
Date applied 19/10/2006
Last edited 29/10/2013
Date ISRCTN assigned 30/04/2007
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