Official Title
Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD
Phase
Phase 3Lead Sponsor
Medice Arzneimittel Pütter GmbH & Co KGStudy Type
InterventionalStatus
Completed No Results PostedIndication/Condition
Attention Deficit Hyperactivity DisorderIntervention/Treatment
methylphenidate ...Study Participants
363Investigation 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
sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
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