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A randomized controlled multicenter trial on the multimodal treatment of adult attention-deficit hyperactivity disorder: enrollment and characteristics of the study sample

  • Alexandra Philipsen
  • Erika Graf
  • Thomas Jans
  • Swantje Matthies
  • Patricia Borel
  • Michael Colla
  • Laura Gentschow
  • Daina Langner
  • Christian Jacob
  • Silke Groß-Lesch
  • Esther Sobanski
  • Barbara Alm
  • Martina Schumacher-Stien
  • Michael Roesler
  • Wolfgang Retz
  • Petra Retz-Junginger
  • Bernhard Kis
  • Mona Abdel-Hamid
  • Viola Heinrich
  • Michael Huss
  • Catherine Kornmann
  • Arne Bürger
  • Ludger Tebartz van Elst
  • Mathias Berger
Original Article

Abstract

Adult ADHD is a frequent psychiatric disorder affecting relevant aspects of an individual’s life. The aim of our study group was to carry out the first randomized controlled multicenter study to evaluate the effects of psychotherapy compared to clinical management in combination with psychopharmacological treatment with methylphenidate (MPH) or placebo (Plac) in a factorial four-arm design. Here, we present the enrollment procedure and description of adult ADHD patients recruited for the trial. Four hundred and thirty-three adult patients with ADHD were randomized at seven study sites in Germany to four treatment conditions: manualized dialectical-behavioral-therapy-based group psychotherapy (GPT) plus MPH or Plac, or clinical management (CM) including supportive counseling plus MPH or Plac with weekly sessions in the first 12 weeks and monthly sessions thereafter. Assessment for eligibility included standardized scales and instruments. After prescreening of 1,480 patients, 518 were evaluated for trial participation and 433 were randomized. The main reasons for prescreening failure were lack of interest in participating (n = 205), difficulties in meeting the time and effort requirements for participation (n = 186), and contraindications for psychopharmacological treatment with MPH (n = 194). The full analysis set (FAS) comprised 419 adult ADHD patients (mean age 35.2 years, males/females 1:1). Fifty-seven percent of the patients suffered from the combined ADHD subtype. Prevalence of at least one current or lifetime axis-I comorbidity was 66 %. Axis-II comorbidity rates was 18 % (patients with comorbid borderline and antisocial personality disorders were excluded). Our network was able to recruit an adult ADHD sample essentially comparable to community samples. A selection bias was created by excluding patients unable or unwilling to participate, or who had somatic and psychiatric contraindications for stimulant treatment (Current Controlled Trials ISRCTN54096201, Funding: Federal Ministry of Education and Research 01GV0606).

Keywords

ADHD Adults Psychotherapy Methylphenidate RCT COMPAS 

Notes

Acknowledgments

Our network on psychotherapy of ADHD is supported by the German Federal Ministry of Education and Research (BMBF; 01GV0605, 01GV0606) within the framework research networks on psychotherapy. Furthermore, we want to thank all members of COMPAS teams at the study sites: Wuerzburg: PD C. Jacob, Dr. T. Jans, Dr. S. Groß-Lesch, M. Heine, A. Boreatti-Hümmer, J. Heupel, S. Reichert, S. Müller, S. Kreiker, A. Gessner, A. Conzelmann, and C. Bähne; Berlin: Dr. M. Colla, L. Gentschow, P. Kunze, and D. Langner; Mannheim: PD Dr. E. Sobanski, Dr. B. Alm, M. Schumacher-Stien, S. Bukow, and S. Argiriou-Martin; Homburg: Prof. Dr. M. Rösler, Prof. Dr. Wofgang Retz, PD Dr. P. Retz-Junginger, Dr. K. Römer, Dr. B. Leipnitz, Dr. S Doyran, and Dr. M. Schulte-Altedorneburg; Essen: Dr. Kis, Dr. M. Abdel-Hamid, V. Heinrich, PD Dr. M. Krämer, and PD Dr. J. Uekermann; Mainz: Prof. Dr. M. Huss, C. Kornmann, A. Bürger, G. Chervenkova, and P. Meinhardt; Freiburg: Prof. Dr. A. Philipsen, Dr. E. Graf, Dr. S. Matthies, Dr. M. Löwer, P. Borel, I. Jansen, S. Bonfico, M. Jooßens, C. Sadohara, M. Weber, M. Kamp, T. Dopatka, Dr. E. Perlov, and Dr. G. Ihorst; and Lörrach: Dr. C. Carl and Dr. C. Keutler. We thank Medice Arzneimittel Puetter GmbH & Co. KG for providing the trial medication (Medikinet retard licensed as Medikinet adult and matching placebo) and particularly Dr. R. Fischer for his advice in preparing the study protocol and his assistance in SAE management. We gratefully thank all participating patients for their cooperation.

Conflict of interest

A. Philipsen: advisory boards, lectures, phase III studies or travel grants within the last 3 years: Eli Lilly, Janssen-Cilag, Medice Arzneimittel Pütter GmbH, Novartis, and Shire, she is an author of books or articles on psychotherapy published by Elsevier, Hogrefe, Schattauer, Kohlhammer, and Karger publishers; E. Graf: none; T. Jans: none; S. Matthies: none; P. Borel: none; M. Colla: advisory boards, speaker’s honoraria or phase III studies within the last 3 years: Shire, Eli Lilly, and Novartis; L. Gentschow: none; D. Langner: none; C. Jacob received speaker’s honoraria by Medice and is member of the advisory boards of Medice; S. Groß-Lesch: none; E. Sobanski: advisory boards, IITs, lectures or Phase III studies within the last 3 years: Medice, Shire, Eli Lilly, and Novartis; B. Alm: advisory boards, lectures or phase III studies within the last 3 years: Medice, Eli Lilly; M. Schuhmacher-Stien: none; M. Rösler is member of the speakers bureau of Medice, Janssen, and Shire; he is a member of the advisory boards of Lilly, Shire, Medice, and Janssen. He performed clinical trials for Medice and Lilly; P. Retz-Junginger received salaries from Hogrefe Publishers; W. Retz received speaker’s honoraria by Medice, is member of the advisory boards of Novartis and Medice, has been involved in clinical trials conducted by BMBF, Vifor, Novartis, and Medice, and is an author of manuals, handbooks, and diagnostic tools published by Hogrefe, Springer, Kohlhammer, and Karger publishers; B. Kis received travel grants by Servier Deutschland GmbH and speaker’s honoraria by Medice and Servier Deutschland GmbH, is a member of the advisory boards of Medice and Novartis Pharma GmbH, and has been involved in clinical trials conducted by Eli Lilly/Lilly Deutschland GmbH; M. Abdel-Hamid: none; V. Heinrich has been involved in clinical trials conducted by Eli Lilly/Lilly Deutschland GmbH; M. Huss: within the past 3 years, he received speaker honoraria from Eli Lilly, Janssen-Cilag, Medice, Novartis, and Shire, he is principal investigator of phase II study sponsored by Lundbeck, principal investigator of several phase III studies sponsored by Shire and Novartis, and principal investigator/sponsor of three IIT studies (investigator initiated trials, phase III and IV) in unrestricted cooperation with Engelhardt Arzneimittel, Steiner Arzneimittel, and Medice; he worked as consultant for Engelhardt, Medice, Shire, and Steiner Arzneimittel and member in the Advisory boards of Eli Lilly, Medice, Novartis, and Shire; C. Kornmann: none; A. Bürger received travel grants by MSAGD in RLP (Ministerium für Soziales, Arbeit, Gesundheit und Demografie) and MBWWK in RLP (Ministerium für Bildung, Wissenschaft, Weiterbildung und Kultur); L. Tebartz van Elst received travel grants by Medtronic, Janssen, Otsuka, Lilly, and SCS and speaker’s honoraria by Otsuka, SCS, Lilly, Medtronic, and Janssen-Cilag; M. Berger: none.

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Copyright information

© Springer-Verlag Wien 2013

Authors and Affiliations

  • Alexandra Philipsen
    • 1
  • Erika Graf
    • 2
  • Thomas Jans
    • 3
  • Swantje Matthies
    • 1
  • Patricia Borel
    • 1
  • Michael Colla
    • 4
  • Laura Gentschow
    • 4
  • Daina Langner
    • 4
  • Christian Jacob
    • 5
  • Silke Groß-Lesch
    • 5
  • Esther Sobanski
    • 6
  • Barbara Alm
    • 6
  • Martina Schumacher-Stien
    • 6
  • Michael Roesler
    • 7
  • Wolfgang Retz
    • 7
  • Petra Retz-Junginger
    • 7
  • Bernhard Kis
    • 8
  • Mona Abdel-Hamid
    • 8
  • Viola Heinrich
    • 8
  • Michael Huss
    • 9
  • Catherine Kornmann
    • 9
  • Arne Bürger
    • 9
  • Ludger Tebartz van Elst
    • 1
  • Mathias Berger
    • 1
  1. 1.Department of Psychiatry and PsychotherapyUniversity Medical Center FreiburgFreiburgGermany
  2. 2.Clinical Trials UnitUniversity Medical Center FreiburgFreiburgGermany
  3. 3.Department of Child and Adolescent Psychiatry, Psychosomatics and PsychotherapyWuerzburg University HospitalWuerzburgGermany
  4. 4.Department of Psychiatry and PsychotherapyCharité-University MedicineBerlinGermany
  5. 5.Department of Psychiatry, Psychosomatics and PsychotherapyWuerzburg University HospitalWuerzburgGermany
  6. 6.Clinic for Psychiatry and PsychotherapyCentral Institute for Mental HealthMannheimGermany
  7. 7.Institute for Forensic Psychology and Psychiatry, Saarland University Faculty of MedicineSaarland University HospitalHomburg/SaarGermany
  8. 8.Department for Psychiatry and Psychotherapy, LVR-Hospital Essen, Faculty of MedicineUniversity of Duisburg-EssenEssenGermany
  9. 9.Clinic for Child and Adolescent Psychiatry and PsychotherapyUniversity Medicine MainzMainzGermany

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