Placebo-Controlled Multi-Centre Double-Blind Trial for Ad... | NCT00619840

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

NCT00619840

Sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Status

Completed

Last Update Posted

Feb 21, 2008Estimated

Enrollment

363Actual

Phase

Phase 3

Conditions

Attention Deficit Hyperactivity Disorder

Interventions

methylphenidate hydrochloride
Placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

May 2006Actual

Completion Date

Not provided

First Submitted Date

Feb 11, 2008

First Submission Date that Met QC Criteria

Feb 11, 2008

First Posted Date

Feb 21, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 11, 2008

Last Update Posted Date

Feb 21, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

363Actual

Label	Type	Description	Intervention Names
1	Active Comparator		Drug: methylphenidate hydrochloride
2	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
methylphenidate hydrochloride	Drug	sustained release, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule	1

Measure	Description	Time Frame
German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI)		Week 24

Measure	Description	Time Frame
CAARS self report: long version (CAARS-S:L)		Week 24

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D019958	Attention Deficit and Disruptive Behavior Disorders
D065886	Neurodevelopmental Disorders
D001523	Mental Disorders

ID	Term
D010648	Phenylacetates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals