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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Medice Arzneimittel Pütter GmbH & Co KG
Sponsor:
Information provided by (Responsible Party):
Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT01615679
First received: June 6, 2012
Last updated: February 20, 2013
Last verified: February 2013
  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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Wender-Reimherr adult attention deficit disorder scale (WRAADDS) - self-report [ Time Frame: 12-14 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: August 2012
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01615679

Contacts
Contact: Michael Rösler, Prof. Dr. 00496841/1626350 michael.roesler@uks.eu

Locations
Germany
Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie Recruiting
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

No publications provided

Responsible Party: Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier: NCT01615679     History of Changes
Other Study ID Numbers: 6520-0660-02
Study First Received: June 6, 2012
Last Updated: February 20, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

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

ClinicalTrials.gov processed this record on September 16, 2014