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

Phase 3

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Drug: methylphenidate hydrochloride; Drug: Placebo

• Registration Number: NCT00619840
• Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co KG

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2006-05
• Status Verified: 2008-02
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Last Update Submitted: 2008-02-11
• Study First Posted: 2008-02-21
• Last Update Posted: 2008-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 363

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	methylphenidate hydrochloride	-
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI)	Week 24

Secondary Outcome Measures

Name	Time	Method
CAARS self report: long version (CAARS-S:L)	Week 24

Trial Locations

Locations (1)

Institute of Forensic Psychology and Psychiatry; 🇩🇪 Homburg/Saar, Sarland, Germany