Official Title

Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD
  • Phase

    Phase 3
  • Study Type

  • Status

    Completed No Results Posted
  • Intervention/Treatment

    methylphenidate ...
  • Study Participants

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
Study Started
Nov 30
Primary Completion
May 31
Last Update
Feb 21

Drug methylphenidate hydrochloride

sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule

  • Other names: Medikinet retard

Drug Placebo

10 mg capsule 1-3 capsules twice daily according to an individual titration schedule

1 Active Comparator

2 Placebo Comparator


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
No Results Posted