Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA

Medice Arzneimittel

Status and phase

Completed

Phase 3

Conditions

Attention Deficit Hyperactivity Disorder

Treatments

Drug: methylphenidate hydrochloride

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00730249

6520-0650-13

Details and patient eligibility

About

Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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