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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co KG
• Treatments: Central Nervous System Stimulants; Methylphenidate

Criteria

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