Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA
This study has been completed.
Sponsor:
Medice Arzneimittel Pütter GmbH & Co KG
Information provided by:
Medice Arzneimittel Pütter GmbH & Co KG
ClinicalTrials.gov Identifier:
NCT00730249
First received: August 6, 2008
Last updated: January 12, 2010
Last verified: January 2010
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: methylphenidate hydrochloride Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Quality Assurance of Administering Methylphenidate in Adults With ADHD |
Resource links provided by NLM:
Further study details as provided by Medice Arzneimittel Pütter GmbH & Co KG:
Primary Outcome Measures:
- Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- CAARS-Self-Report: Long Version (CAARS-S:L) [ Time Frame: 20 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2008 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: methylphenidate hydrochloride
sustained release, twice daily, dosage according to an individual titration schedule
Other Name: Medikinet retard
|
| Placebo Comparator: 2 |
Drug: Placebo
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 out-patient
- score of 85 or greater in IQ-test (MWT-B)
- diagnosis of ADHD according ADHS-CL (DSM IV) and WRAADDS > 35 points
- ADHD symptoms have existed since childhood (WURS-k >= 30)
- Body Mass Index >= 20 and body weight < 130 kg
- willing to eat breakfast and lunch
- 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 two weeks before screening
- shift work or night work
- alcohol, medication or drug dependency in the past six months or manifest drug abuse
- diagnosis of a psychosis (SKID-I)
- epileptic attacks in the past
- EEG result which suggests epilepsy
- acute depressive episode according to ICD-10 F32.2 and ICD-10 F32.3 (Beck-Depression-Inventory > 18)
- Illness 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
- creatinine > 1,5 x upper norm-range
- clinically relevant liver disorder
- SGOT and/or SGPT > 2 x upper norm-range
- pathological ECG-finding
- QTc > 450 msec in male, QTc > 470 msec in female
- high blood pressure (anamnesis or blood pressure > 140/90 mm Hg at screening)
- known acclusive arterial disease
- angina pectoris (anamnesis or ECG-finding)
- cardiac arrhythmias (anamnesis or ECG-finding)
- KHK (anamnesis or ECG-finding)
- post heart-attack status (anamnesis or ECG-finding)
- post stroke status
- known elevated intra-ocular pressure
- known enlarged prostates
- latent and manifest hyperthyreosis
- TSH < lower norm-range
- patient with a terminal disease (e.g. cancer)
- 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 (contraceptives, intrauterine device , no sexual intercourse)
- pregnancy (positive pregnancy test) or lactation period
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730249
Locations
| Germany | |
| Praxis Johannes Fuhr | |
| Bad Wildungen, Germany, 34537 | |
| Charité Campus Mitte, Station 155 | |
| Berlin, Germany, 10117 | |
| Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie | |
| Berlin, Germany, 10789 | |
| Universitätsklinik Bochum | |
| Bochum, Germany, 44791 | |
| Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie | |
| Freiburg, Germany, 79104 | |
| Praxis Dr. Heinrich Goossens-Merkt | |
| Hamburg, Germany, 22527 | |
| Universitäts-Klinik Eppendorf, | |
| Hamburg, Germany, 20246 | |
| Universität des Saarlandes, Institut für gerichtliche Psychiatrie | |
| Homburg, Germany, 66421 | |
| Praxis Thomas Wirth | |
| Ludwigsburg, Germany, 71636 | |
| Zentralinstitut für seelische Gesundheit | |
| Mannheim, Germany, 68159 | |
| Medizinisches Studienzentrum Würzburg | |
| Würzburg, Germany, 97070 | |
Sponsors and Collaborators
Medice Arzneimittel Pütter GmbH & Co KG
Investigators
| Study Chair: | Roland Fischer, Dr. | Medice Arzneimittel Pütter GmbH & Co KG |
| Study Director: | Michael Rösler, Prof. Dr. | Universität des Saarlandes, Institut für gerichtliche Psychiatrie |
More Information
No publications provided
| Responsible Party: | Dr. Roland Fischer/Head of Medical Dept., Medice Arzneimittel Pütter GmbH & Co. KG |
| ClinicalTrials.gov Identifier: | NCT00730249 History of Changes |
| Other Study ID Numbers: | 6520-0650-13 |
| Study First Received: | August 6, 2008 |
| Last Updated: | January 12, 2010 |
| 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 controlled clinical trial |
safety randomized, double-blind, placebo-controlled trial treatment central nervous system stimulants therapeutic uses |
Additional relevant MeSH terms:
|
Attention Deficit Disorder with Hyperactivity Hyperkinesis Attention Deficit and Disruptive Behavior Disorders Mental Disorders Diagnosed in Childhood Mental Disorders Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Central Nervous System Stimulants |
Methylphenidate Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Dopamine Uptake Inhibitors Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Neurotransmitter Uptake Inhibitors |
ClinicalTrials.gov processed this record on May 23, 2013