Status:
COMPLETED
Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD
Lead Sponsor:
Medice Arzneimittel Pütter GmbH & Co KG
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT00619840
Start Date
November 1 2004
Last Update
February 21 2008
Active Locations (1)
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1
Institute of Forensic Psychology and Psychiatry
Homburg/Saar, Saarland, Germany, 66421