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

Sponsored by:	Medice Arzneimittel Pütter GmbH & Co KG
Information provided by:	Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier:	NCT00619840

Purpose

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	Intervention	Phase
Attention Deficit Hyperactivity Disorder	Drug: methylphenidate hydrochloride Drug: Placebo	Phase III

MedlinePlus related topics: Attention Deficit Hyperactivity Disorder

Drug Information available for: Methylphenidate Methylphenidate hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD

Further study details as provided by Medice Arzneimittel Pütter GmbH & Co KG:

Primary Outcome Measures:

German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CAARS self report: long version (CAARS-S:L) [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Enrollment:	363
Study Start Date:	November 2004
Primary Completion Date:	May 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Drug: methylphenidate hydrochloride sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
2: Placebo Comparator	Drug: Placebo 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00619840

Locations

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

Sponsors and Collaborators

Medice Arzneimittel Pütter GmbH & Co KG

Investigators

Principal Investigator:

Michael Rösler, Prof. Dr.

Institute of Forensic Psychology and Psychiatry, University of Saarland

More Information

No publications provided

Responsible Party:	Medice Arzneimittel Pütter GmbH & Co. KG ( Dr. Roland Fischer/Head of Medical Dept. )
Study ID Numbers:	6520-9979-06
Study First Received:	February 11, 2008
Last Updated:	February 11, 2008
ClinicalTrials.gov Identifier:	NCT00619840 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

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

Study placed in the following topic categories:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias
Signs and Symptoms

Dopamine
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Nervous System Diseases
Physiological Effects of Drugs
Attention Deficit and Disruptive Behavior Disorders
Methylphenidate
Central Nervous System Stimulants
Dyskinesias

Pharmacologic Actions
Signs and Symptoms
Attention Deficit Disorder with Hyperactivity
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Hyperkinesis
Neurologic Manifestations
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009