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

Primary Purpose

Attention Deficit Hyperactivity Disorder

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
methylphenidate hydrochloride
Placebo
Sponsored by
Medice Arzneimittel Pütter GmbH & Co KG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Forensic Psychology and Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI)

Secondary Outcome Measures

CAARS self report: long version (CAARS-S:L)

Full Information

First Posted
February 11, 2008
Last Updated
February 11, 2008
Sponsor
Medice Arzneimittel Pütter GmbH & Co KG
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1. Study Identification

Unique Protocol Identification Number
NCT00619840
Brief Title
Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD
Acronym
EMMA
Official Title
Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD
Study Type
Interventional

2. Study Status

Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Medice Arzneimittel Pütter GmbH & Co KG

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
363 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
methylphenidate hydrochloride
Other Intervention Name(s)
Medikinet retard
Intervention Description
sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
Primary Outcome Measure Information:
Title
German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI)
Time Frame
Week 24
Secondary Outcome Measure Information:
Title
CAARS self report: long version (CAARS-S:L)
Time Frame
Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Rösler, Prof. Dr.
Organizational Affiliation
Institute of Forensic Psychology and Psychiatry, University of Saarland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Forensic Psychology and Psychiatry
City
Homburg/Saar
State/Province
Sarland
ZIP/Postal Code
66421
Country
Germany

12. IPD Sharing Statement

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

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