Attention Deficit Hyperactivity Disorder
Conditions
Keywords
ADHD, Attention Deficit Hyperactivity Disorder, adult, methylphenidate hydrochloride, Medikinet retard, controlled clinical trial, safety, randomized, double-blind, placebo-controlled trial, treatment, central nervous system stimulants, therapeutic uses
Brief summary
Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo
Interventions
DRUGmethylphenidate hydrochloride
sustained release, twice daily, dosage according to an individual titration schedule
DRUGPlacebo
twice daily according to an individual titration schedule
Sponsors
Medice Arzneimittel Pütter GmbH & Co KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6) | 20 weeks |
Secondary
| Measure | Time frame |
|---|---|
| CAARS-Self-Report: Long Version (CAARS-S:L) | 20 weeks |
Countries
Germany
Outcome results
None listed