Additional identifiers
EudraCT number
2006-000222-31
ClinicalTrials.gov number
Protocol/serial number
Code: 070170
Study information
Scientific title
Effects and mechanisms of psychotherapy in the treatment of attention deficit hyperactivity disorder in adults: the first randomised multicentre study
Acronym
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
Ethics approval
Ethik-Kommission der Albert-Ludwigs-Universität Freiburg, 19/10/2006, ref: 217/06
Study design
Controlled randomised multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Attention Deficit Hyperactivity Disorder (ADHD)
Intervention
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
Intervention type
Drug
Phase
Not Applicable
Drug names
Methylphenidate
Primary outcome measure
Conners Adult ADHD Rating Scale (CAARS-O, blind-observer rated).
Secondary outcome measures
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
Overall trial start date
01/11/2006
Overall trial end date
31/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
ADHD according to the Diagnostic and Statistical Manual of Mental Disorders - fourth edition (DSM-IV) criteria
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
448
Total final enrolment
433
Participant 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
Recruitment start date
01/11/2006
Recruitment end date
31/10/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Hauptstrasse 5
Freiburg
D-79104
Germany
Sponsor information
Organisation
University of Freiburg Medical School (Germany)
Sponsor details
Hauptstrasse 5
Freiburg
D-79104
Germany
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Bundesministerium für Bildung und Forschung
Alternative name(s)
Federal Ministry of Education and Research, BMBF
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
Germany
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
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
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26536057
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28745107 (added 04/09/2019)
2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31150084 (added 04/09/2019)
Publication citations
-
Protocol
Philipsen A, Graf E, Tebartz van Elst L, Jans T, Warnke A, Hesslinger B, Ebert D, Gerlach M, Matthies S, Colla M, Jacob C, Sobanski E, Alm B, Rösler M, Ihorst G, Gross-Lesch S, Gentschow L, Kis B, Huss M, Lieb K, Schlander M, Berger M, Evaluation of the efficacy and effectiveness of a structured disorder tailored psychotherapy in ADHD in adults: study protocol of a randomized controlled multicentre trial., Atten Defic Hyperact Disord, 2010, 2, 4, 203-212, doi: 10.1007/s12402-010-0046-7.
-
Enrollment and characteristics of the study sample
Philipsen A, Graf E, Jans T, Matthies S, Borel P, Colla M, Gentschow L, Langner D, Jacob C, Groß-Lesch S, Sobanski E, Alm B, Schumacher-Stien M, Roesler M, Retz W, Retz-Junginger P, Kis B, Abdel-Hamid M, Heinrich V, Huss M, Kornmann C, Bürger A, van Elst LT, Berger M, A randomized controlled multicenter trial on the multimodal treatment of adult attention-deficit hyperactivity disorder: enrollment and characteristics of the study sample., Atten Defic Hyperact Disord, 2014, 6, 1, 35-47, doi: 10.1007/s12402-013-0120-z.
-
Results
Philipsen A, Jans T, Graf E, Matthies S, Borel P, Colla M, Gentschow L, Langner D, Jacob C, Groß-Lesch S, Sobanski E, Alm B, Schumacher-Stien M, Roesler M, Retz W, Retz-Junginger P, Kis B, Abdel-Hamid M, Heinrich V, Huss M, Kornmann C, Bürger A, Perlov E, Ihorst G, Schlander M, Berger M, Tebartz van Elst L; Comparison of Methylphenidate and Psychotherapy in Adult ADHD Study (COMPAS) Consortium, Effects of Group Psychotherapy, Individual Counseling, Methylphenidate, and Placebo in the Treatment of Adult Attention-Deficit/Hyperactivity Disorder: A Randomized Clinical Trial, JAMA Psychiatry, 2015 , 1-13, doi: 10.1001/jamapsychiatry.2015.2146.