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

Attention Deficit Hyperactivity Disorder Clinical Trial

— EMMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00619840
• Other study ID #: 6520-9979-06
• Status: Completed
• Phase: Phase 3
• First received: February 11, 2008
• Last updated: February 11, 2008
• Start date: November 2004

Study information

• Verified date: February 2008
• Source: Medice Arzneimittel Pütter GmbH & Co KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 363
• Est. primary completion date: May 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder
• Hyperkinesis

Intervention

Drug:
• methylphenidate hydrochloride
sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule
• Placebo
10 mg capsule 1-3 capsules twice daily according to an individual titration schedule

Locations

Country	Name	City	State
Germany	Institute of Forensic Psychology and Psychiatry	Homburg/Saar	Sarland

Sponsors (1)

Lead Sponsor	Collaborator
Medice Arzneimittel Pütter GmbH & Co KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI)		Week 24	No
Secondary	CAARS self report: long version (CAARS-S:L)		Week 24	No