Condition category
Mental and Behavioural Disorders
Date applied
19/10/2006
Date assigned
30/04/2007
Last edited
05/11/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Alexandra Philipsen

ORCID ID

Contact details

Hauptstrasse 5
Freiburg
D-79104
Germany

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 measures

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

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

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

http://www.uniklinik-freiburg.de/ims/live/index_en.html

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

federal

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

Results - basic reporting

Publication summary

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

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes