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

NCT ID: NCT01615679

Last Updated: 2015-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

468 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Adult Attention-deficit/Hyperactivity Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medice Arzneimittel Pütter GmbH & Co KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Roland Fischer, Dr.

Role: STUDY_CHAIR

Medice Arzneimittel Pütter GmbH & Co KG

Michael Rösler, Prof. Dr.

Role: STUDY_DIRECTOR

Universität des Saarlandes, Institut für Gerichtliche Psychologie und Psychiatrie

Locations

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Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie

Homburg, , Germany

Site Status

Countries

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Germany

Other Identifiers

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6520-0660-02

Identifier Type: -

Identifier Source: org_study_id

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