Clinical trial NCT00619840: Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD
Official title: Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Medice Arzneimittel Pütter GmbH & Co KG
Sponsor class: INDUSTRY
First posted: 2008-02-21
Enrollment: 363
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI)
timeFrame: Week 24
Secondary outcomes:
measure: CAARS self report: long version (CAARS-S:L)
timeFrame: Week 24
Other outcomes:
Locations:
city: Homburg/Saar
country: Germany
facility: Institute of Forensic Psychology and Psychiatry
state: Sarland
Study officials:
affiliation: Institute of Forensic Psychology and Psychiatry, University of Saarland
name: Michael Rösler, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: