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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01615679

Acronym

IDEA

Enrollment

468

Registered

2012-06-08

Start date

2012-08-31

Completion date

2014-08-31

Last updated

2015-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult Attention-deficit/Hyperactivity Disorder

Keywords

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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,

Design outcomes

Primary

Measure	Time frame
Clinical Global Impression (CGI)	12-14 weeks

Secondary

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

Countries

Germany

Outcome results