Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD (EMMA)

February 11, 2008 updated by: Medice Arzneimittel Pütter GmbH & Co KG
Investigation of efficacy and tolerability of extended-release MPD in adults with ADHD, compared with a placebo, and to acquire knowledge through long-term observation of adults

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

363

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Sarland
      • Homburg/Saar, Sarland, Germany, 66421
        • Institute of Forensic Psychology and Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient treated as outpatient or inpatient
  • Patient has a good command of German
  • Score of 85 or greater in the IQ test (MWT-B)
  • Diagnosis of ADHD according to ADHD-CL (DSM IV) and WRI-WRAADDS > 28 points
  • ADHD symptoms have existed since childhood (WURS-k >= 30)
  • Body mass index >= 20
  • Willing to eat breakfast
  • Patient is willing and able to come to the observation appointments
  • Written consent of the patient to participate in the study

Exclusion Criteria:

  • Treatment with psychostimulants in the past 2 weeks
  • Inconsistencies in the CAARS- S:L >= 8 (Inconsistency Index)
  • Shift work or night work
  • Alcohol, medication or drug dependency in the past 6 months or manifest drug abuse
  • Diagnosis of a psychosis (SKID-I)
  • Epileptic attacks in the past
  • EEG results which suggest epilepsy
  • Clinically relevant liver disease
  • Clinically relevant hyperthyroidism (relevantly elevated TSH, T4)
  • Acute depressive episode according to ICD-10 F32.2 and ICD-10 32.3 (SKID-I)
  • Illnesses with schizophrenic symptoms (SKID-I)
  • Acute manic episode, bipolar disorder (SKID-I)
  • Diagnosis of a tic disorder
  • Acute anorexia
  • Acute prominent panic disorder and generalised anxiety (SKID-I)
  • Clinically relevant kidney disorders
  • Known high blood pressure
  • Known occlusive arterial disease
  • Known angina pectoris
  • Known coronary heart disease and state after myocardial infarction
  • Known tachycardial arrhythmias
  • Post-stroke status
  • Known elevated intra-occular pressure
  • Known enlarged prostates
  • Participation in a clinical study within the past 30 days
  • Participation in this study at an earlier point in time
  • Simultaneous participation in another clinical trial
  • Women of child-bearing age without adequate contraception
  • Patients with terminal illness (e.g. cancer)
  • Pregnancy (positive pregnancy test) or lactation period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
Drug: Placebo
10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
Active Comparator: 1
Drug: methylphenidate hydrochloride
sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
Other Names:
  • Medikinet retard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI)
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
CAARS self report: long version (CAARS-S:L)
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Investigators

  • Principal Investigator: Michael Rösler, Prof. Dr., Institute of Forensic Psychology and Psychiatry, University of Saarland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2004

Primary Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

February 11, 2008

First Submitted That Met QC Criteria

February 11, 2008

First Posted (Estimate)

February 21, 2008

Study Record Updates

Last Update Posted (Estimate)

February 21, 2008

Last Update Submitted That Met QC Criteria

February 11, 2008

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6520-9979-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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