Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD (EMMA)

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

NCT00619840

6520-9979-06

Details and patient eligibility

About

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

Enrollment

363 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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