Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA

Attention Deficit Hyperactivity Disorder Clinical Trial

— QUMEA  

Official title:

Quality Assurance of Administering Methylphenidate in Adults With ADHD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00730249
• Other study ID #: 6520-0650-13
• Status: Completed
• Phase: Phase 3
• First received: August 6, 2008
• Last updated: January 12, 2010
• Start date: September 2008

Study information

• Verified date: January 2010
• Source: Medice Arzneimittel Pütter GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• methylphenidate hydrochloride
sustained release, twice daily, dosage according to an individual titration schedule
• Placebo
twice daily according to an individual titration schedule

Locations

Country	Name	City	State
Germany	Praxis Johannes Fuhr	Bad Wildungen
Germany	Charité Campus Mitte, Station 155	Berlin
Germany	Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie	Berlin
Germany	Universitätsklinik Bochum	Bochum
Germany	Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie	Freiburg
Germany	Praxis Dr. Heinrich Goossens-Merkt	Hamburg
Germany	Universitäts-Klinik Eppendorf,	Hamburg
Germany	Universität des Saarlandes, Institut für gerichtliche Psychiatrie	Homburg
Germany	Praxis Thomas Wirth	Ludwigsburg
Germany	Zentralinstitut für seelische Gesundheit	Mannheim
Germany	Medizinisches Studienzentrum Würzburg	Würzburg

Sponsors (1)

Lead Sponsor	Collaborator
Medice Arzneimittel Pütter GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6)		20 weeks	No
Secondary	CAARS-Self-Report: Long Version (CAARS-S:L)		20 weeks	No