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

NCT00619840 | Completed Phase 3

• 1 other identifier: 6520-9979-06
• Study Type: interventional
• Target: 363
• Locations: 1 country
• Sites: 1

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

Keywords

ADHD; Attention Deficit Hyperactivity Disorder; adult; methylphenidate hydrochloride; Medikinet retard; long-term observation; controlled clinical trial; safety; randomized, double-blind, placebo-controlled trial; treatment; central nervous system stimulants; therapeutic uses

Outcome Measures

Primary Outcomes (1)

• German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI)

  Week 24

Secondary Outcomes (1)

• CAARS self report: long version (CAARS-S:L)

  Week 24

Study Arms (2)

1

ACTIVE COMPARATOR

Drug: methylphenidate hydrochloride

2

PLACEBO COMPARATOR

Drug: Placebo

Interventions

methylphenidate hydrochloride DRUG

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

Also known as: Medikinet retard

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Medice Arzneimittel Pütter GmbH & Co KG: lead

Study Sites (1)

Institute of Forensic Psychology and Psychiatry

Homburg/Saar, Saarland, 66421, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Michael Rösler, Prof. Dr.

  Institute of Forensic Psychology and Psychiatry, University of Saarland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 11, 2008
• First Posted: February 21, 2008
• Study Start: November 1, 2004
• Primary Completion: May 1, 2006
• Last Updated: February 21, 2008

Record last verified: 2008-02

Locations

DE (1)