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Completed

NCT Number: NCT01615679

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

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.

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Key information

Conditions

Adult Attention-deficit/Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie

Homburg, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Primary outcomes

  1. Clinical Global Impression (CGI)

    Time frame: 12-14 weeks

Secondary outcomes

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

    Time frame: 12-14 weeks

Sponsors and collaborators

Lead sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Industry

Registry information

Official study title

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

Acronym: IDEA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 8, 2012
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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