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

NCT ID: NCT00619840

Last Updated: 2008-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 363 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30

Brief 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

Conditions

Attention Deficit Hyperactivity Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

1

Group Type: ACTIVE_COMPARATOR

methylphenidate hydrochloride

Intervention Type: DRUG

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

2

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

methylphenidate hydrochloride

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Medikinet retard

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medice Arzneimittel Pütter GmbH & Co KG

INDUSTRY

Sponsor Role: lead

Responsible Party

Medice Arzneimittel Pütter GmbH & Co. KG

Principal Investigators

Michael Rösler, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Institute of Forensic Psychology and Psychiatry, University of Saarland

Locations

Institute of Forensic Psychology and Psychiatry

Homburg/Saar, Saarland, Germany

Countries

Germany

Other Identifiers

6520-9979-06

Identifier Type: -

Identifier Source: org_study_id