Integrated Diagnosis and Treatment of Adults With Attention-deficit/Hyperactivity Disorder (IDEA)
This study is currently recruiting participants.
Verified February 2013 by Medice Arzneimittel Pütter GmbH & Co KG
Sponsor:
Medice Arzneimittel Pütter GmbH & Co KG
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
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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
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 Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms |
ClinicalTrials.gov processed this record on May 16, 2013