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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01615679
First Posted: June 8, 2012
Last Update Posted: April 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Medice Arzneimittel Pütter GmbH & Co KG
  Purpose
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.

Condition
Adult Attention-deficit/Hyperactivity Disorder

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder (ADHD)

Resource links provided by NLM:


Further study details as provided by Medice Arzneimittel Pütter GmbH & Co KG:

Primary Outcome Measures:
  • Clinical Global Impression (CGI) [ Time Frame: 12-14 weeks ]

Secondary Outcome Measures:
  • Wender-Reimherr adult attention deficit disorder scale (WRAADDS) - self-report [ Time Frame: 12-14 weeks ]

Enrollment: 468
Study Start Date: August 2012
Study Completion Date: August 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

  • Adult patients with newly diagnosed ADHD

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,
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01615679


Locations
Germany
Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie
Homburg, Germany
Sponsors and Collaborators
Medice Arzneimittel Pütter GmbH & Co KG
Investigators
Study Chair: Roland Fischer, Dr. Medice Arzneimittel Pütter GmbH & Co KG
Study Director: Michael Rösler, Prof. Dr. Universität des Saarlandes, Institut für Gerichtliche Psychologie und Psychiatrie
  More Information

Responsible Party: Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier: NCT01615679     History of Changes
Other Study ID Numbers: 6520-0660-02
First Submitted: June 6, 2012
First Posted: June 8, 2012
Last Update Posted: April 15, 2015
Last Verified: April 2015

Keywords provided by Medice Arzneimittel Pütter GmbH & Co KG:
Non-interventional study
Attention Deficit/Hyperactivity Disorder
ADHD

Additional relevant MeSH terms:
Disease
Attention Deficit Disorder with Hyperactivity
Hyperkinesis
Pathologic Processes
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms