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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00619840
Recruitment Status : Completed
First Posted : February 21, 2008
Last Update Posted : February 21, 2008
Sponsor:
Information provided by:
Medice Arzneimittel Pütter GmbH & Co KG

Brief Summary:
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

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Drug: methylphenidate hydrochloride Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 363 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD
Study Start Date : November 2004
Actual Primary Completion Date : May 2006

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1 Drug: methylphenidate hydrochloride
sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
Other Name: Medikinet retard

Placebo Comparator: 2 Drug: Placebo
10 mg capsule 1-3 capsules twice daily according to an individual titration schedule




Primary Outcome Measures :
  1. German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI) [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. CAARS self report: long version (CAARS-S:L) [ Time Frame: Week 24 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00619840


Locations
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Germany
Institute of Forensic Psychology and Psychiatry
Homburg/Saar, Sarland, Germany, 66421
Sponsors and Collaborators
Medice Arzneimittel Pütter GmbH & Co KG
Investigators
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Principal Investigator: Michael Rösler, Prof. Dr. Institute of Forensic Psychology and Psychiatry, University of Saarland
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Responsible Party: Dr. Roland Fischer/Head of Medical Dept., Medice Arzneimittel Pütter GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT00619840    
Other Study ID Numbers: 6520-9979-06
First Posted: February 21, 2008    Key Record Dates
Last Update Posted: February 21, 2008
Last Verified: February 2008
Keywords provided by Medice Arzneimittel Pütter GmbH & Co KG:
ADHD
Attention Deficit Hyperactivity Disorder
adult
methylphenidate hydrochloride
Medikinet retard
long-term observation
controlled clinical trial
safety
randomized, double-blind, placebo-controlled trial
treatment
central nervous system stimulants
therapeutic uses
Additional relevant MeSH terms:
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Hyperkinesis
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Methylphenidate
Central Nervous System Stimulants
Physiological Effects of Drugs
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Dopamine Agents
Neurotransmitter Agents