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

April 14, 2015 updated by: Medice Arzneimittel Pütter GmbH & Co KG

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

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

468

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Homburg, Germany
        • Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical Global Impression (CGI)
Time Frame: 12-14 weeks
12-14 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Wender-Reimherr adult attention deficit disorder scale (WRAADDS) - self-report
Time Frame: 12-14 weeks
12-14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

June 6, 2012

First Submitted That Met QC Criteria

June 7, 2012

First Posted (Estimate)

June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

April 15, 2015

Last Update Submitted That Met QC Criteria

April 14, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6520-0660-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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