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

NCT01615679 | Completed

• 1 other identifier: 6520-0660-02
• Study Type: observational
• Target: 468
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adult Attention-deficit/Hyperactivity Disorder

Keywords

Non-interventional study; Attention Deficit/Hyperactivity Disorder; ADHD

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impression (CGI)

  12-14 weeks

Secondary Outcomes (1)

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

  12-14 weeks

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Adult patients with newly diagnosed ADHD

You may not qualify if:

• 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,

Sponsors & Collaborators

• Medice Arzneimittel Pütter GmbH & Co KG: lead

Study Sites (1)

Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie

Homburg, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Roland Fischer, Dr.

  Medice Arzneimittel Pütter GmbH & Co KG

  STUDY CHAIR

• Michael Rösler, Prof. Dr.

  Universität des Saarlandes, Institut für Gerichtliche Psychologie und Psychiatrie

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2012
• First Posted: June 8, 2012
• Study Start: August 1, 2012
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

DE (1)