NCT01615679

Completed

Integrated Diagnosis and Treatment of Adults With Attention-...

Medice Arzneimittel Pütter GmbH & Co KG Source

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Other study identifiers

Sponsor study identifier

6520-0660-02

Study Type

observational

Actual enrollment (reported)

468

Locations

1 country

Sites

1

Timeline

Study Start

August 2012

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

March 2014

Actual (reported)

Study Completion

August 2014

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 468 participants
Study completion date: August 2014
Actual (reported)
Listed locations: 1 countries · 1 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
June 6, 2012
Actual (reported)
First Posted
June 8, 2012
Actual (reported)
Study Start
August 2012
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
March 2014
Actual (reported)
Study Completion
August 2014
Actual (reported)

Last Updated: April 15, 2015
Status Verified: April 2015
Last Update Submitted: April 14, 2015

Conditions

Adult Attention-deficit/Hyperactivity Disorder

Keywords

Non-interventional studyAttention Deficit/Hyperactivity DisorderADHD

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

Age18 Years - 65 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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:

Sponsors & Collaborators

Medice Arzneimittel Pütter GmbH & Co KG
Industrylead

Study Sites (1)

Universität des Saarlandes, Gerichtliche Psychologie und Psychiatrie

Homburg, Germany

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental 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

Enrollment

468 participants (actual enrollment reported by the registry).

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 2012

Date type not reported

This date has not been verified as actual or estimated.

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,

Contact the study team to confirm eligibility.

Primary Completion

March 2014

Actual (reported)

Study Completion

August 2014

Actual (reported)

Last Updated

April 15, 2015

Record last verified: 2015-04

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT01615679
Data provider: ClinicalTrials.gov
Source updated: 2015-04-15
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:40:15 UTC

Locations

DE(1)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

Source record

Locations