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

Adult Attention-deficit/Hyperactivity Disorder Clinical Trial

— IDEA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01615679
• Other study ID #: 6520-0660-02
• Status: Completed
• Phase: N/A
• First received: June 6, 2012
• Last updated: April 14, 2015
• Start date: August 2012
• Est. completion date: August 2014

Study information

• Verified date: April 2015
• Source: Medice Arzneimittel Pütter GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 468
• Est. completion date: August 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Adult Attention-deficit/Hyperactivity Disorder
• Attention Deficit Disorder with Hyperactivity
• Hyperkinesis

Locations

Country	Name	City	State
Germany	Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie	Homburg

Sponsors (1)

Lead Sponsor	Collaborator
Medice Arzneimittel Pütter GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Global Impression (CGI)		12-14 weeks	No
Secondary	Wender-Reimherr adult attention deficit disorder scale (WRAADDS) - self-report		12-14 weeks	No