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CompletedNCT01615679IDEAUpdated Apr 15, 2015

Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder

An observational study in Adult Attention-deficit/Hyperactivity Disorder, sponsored by Medice Arzneimittel Pütter GmbH & Co KG. Completed at 1 site in Germany. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2015-04-15.

Sponsored by Medice Arzneimittel Pütter GmbH & Co KG · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
468
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Non-interventional study to gain further information about the therapy progression in routine treatment of adults with attention-deficit/hyperactivity disorder (ADHD). Main focus will be on the improvement of the clinical global impression (CGI) in comparison to the outcome of randomized, controlled studies.

02

Conditions studied

  • Adult Attention-deficit/Hyperactivity Disorder

Keywords

  • Non-interventional study
  • Attention Deficit/Hyperactivity Disorder
  • ADHD
03

In context

Hyperkinesis

729 studies on the registry are indexed under Hyperkinesis; 25 are open to participants now.

This study's enrollment of 468 is above the median of 134 across 122 observational studies indexed under Hyperkinesis.

Browse Hyperkinesis studies →

Lead sponsor

Medice Arzneimittel Pütter GmbH & Co KG is the lead sponsor of 10 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients with newly diagnosed ADHD who shall be treated with Medikinet(R) adult.

Inclusion criteria

  • Adult patients with newly diagnosed ADHD

Exclusion criteria

Exclusion Criteria:

  • Known sensitivity to methylphenidate or any of the excipients
  • Glaucoma
  • Phaeochromocytoma
  • During treatment with non-selective, irreversible monoamine oxidase (MAO) inhibitors, or within a minimum of 14 days of discontinuing those drugs, due to risk of hypertensive crisis
  • Hyperthyroidism or Thyrotoxicosis
  • Diagnosis or history of severe depression, anorexia nervosa/anorexic disorders, suicidal tendencies, psychotic symptoms, severe mood disorders, mania, schizophrenia, psychopathic/borderline personality disorder.
  • Diagnosis or history of severe and episodic (Type I) Bipolar (affective) Disorder (that is not well-controlled)
  • pre-existing cardiovascular disorders including severe hypertension, heart failure, arterial occlusive disease, angina, haemodynamically significant congenital heart disease, cardiomyopathies, myocardial infarction, potentially life-threatening arrhythmias and channelopathies (disorders caused by the dysfunction of ion channels)
  • pre-existing cerebrovascular disorders cerebral aneurysm, vascular abnormalities including vasculitis or stroke
  • a history of pronounced anacidity of the stomach with a pH value above 5.5, in therapy with H2-receptor blockers or in antacid therapy,
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
468 participants (actual)
06

What researchers measure

Primary outcomes

  1. Clinical Global Impression (CGI)

    Time frame: 12-14 weeks

Secondary outcomes

  1. Wender-Reimherr adult attention deficit disorder scale (WRAADDS) - self-report

    Time frame: 12-14 weeks

07

Study locations

1 site
  • Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie
    Homburg, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01615679
Lead sponsor
Medice Arzneimittel Pütter GmbH & Co KG
Responsible party
Sponsor
First posted
Jun 8, 2012
Start date
Aug 2012
Primary completion
Mar 2014
Completion
Aug 2014
Last update
Apr 15, 2015

Study contacts

Roland Fischer, Dr.
study chair · Medice Arzneimittel Pütter GmbH & Co KG
Michael Rösler, Prof. Dr.
study director · Universität des Saarlandes, Institut für Gerichtliche Psychologie und Psychiatrie

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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