NCT00730249

Brief Summary

Investigation of efficacy of high-dose extended-release Methylphenidate in adults with ADHD, compared with a placebo

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 6, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2008

Completed
24 days until next milestone

Study Start

First participant enrolled

September 1, 2008

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Last Updated

January 13, 2010

Status Verified

January 1, 2010

Enrollment Period

1.3 years

First QC Date

August 6, 2008

Last Update Submit

January 12, 2010

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHDAttention Deficit Hyperactivity Disorderadultmethylphenidate hydrochlorideMedikinet retardcontrolled clinical trialsafetyrandomized, double-blind, placebo-controlled trialtreatmentcentral nervous system stimulantstherapeutic uses

Outcome Measures

Primary Outcomes (1)

  • Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6)

    20 weeks

Secondary Outcomes (1)

  • CAARS-Self-Report: Long Version (CAARS-S:L)

    20 weeks

Study Arms (2)

1

ACTIVE COMPARATOR
Drug: methylphenidate hydrochloride

2

PLACEBO COMPARATOR
Drug: Placebo

Interventions

methylphenidate hydrochlorideDRUG

sustained release, twice daily, dosage according to an individual titration schedule

Also known as: Medikinet retard
1
PlaceboDRUG

twice daily according to an individual titration schedule

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patient treated as out-patient
  • score of 85 or greater in IQ-test (MWT-B)
  • diagnosis of ADHD according ADHS-CL (DSM IV) and WRAADDS \> 35 points
  • ADHD symptoms have existed since childhood (WURS-k \>= 30)
  • Body Mass Index \>= 20 and body weight \< 130 kg
  • willing to eat breakfast and lunch
  • 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 two weeks before screening
  • shift work or night work
  • alcohol, medication or drug dependency in the past six months or manifest drug abuse
  • diagnosis of a psychosis (SKID-I)
  • epileptic attacks in the past
  • EEG result which suggests epilepsy
  • acute depressive episode according to ICD-10 F32.2 and ICD-10 F32.3 (Beck-Depression-Inventory \> 18)
  • Illness 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
  • creatinine \> 1,5 x upper norm-range
  • clinically relevant liver disorder
  • +20 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Praxis Johannes Fuhr

Bad Wildungen, 34537, Germany

Location

Charité Campus Mitte, Station 155

Berlin, 10117, Germany

Location

Gemeinschaftspraxis für Kinder- und Jugendpsychiatrie, Psychotherapie

Berlin, 10789, Germany

Location

Universitätsklinik Bochum

Bochum, 44791, Germany

Location

Universitätsklinikum Freiburg, Abteilung für Psychiatrie und Psychotherapie

Freiburg im Breisgau, 79104, Germany

Location

Universitäts-Klinik Eppendorf,

Hamburg, 20246, Germany

Location

Praxis Dr. Heinrich Goossens-Merkt

Hamburg, 22527, Germany

Location

Universität des Saarlandes, Institut für gerichtliche Psychiatrie

Homburg, 66421, Germany

Location

Praxis Thomas Wirth

Ludwigsburg, 71636, Germany

Location

Zentralinstitut für seelische Gesundheit

Mannheim, 68159, Germany

Location

Medizinisches Studienzentrum Würzburg

Würzburg, 97070, Germany

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Roland Fischer, Dr.

    Medice Arzneimittel Pütter GmbH & Co KG

    STUDY CHAIR

  • Michael Rösler, Prof. Dr.

    Universität des Saarlandes, Institut für gerichtliche Psychiatrie

    STUDY DIRECTOR

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

August 6, 2008

First Posted

August 8, 2008

Study Start

September 1, 2008

Primary Completion

January 1, 2010

Last Updated

January 13, 2010

Record last verified: 2010-01

Locations

DE(11)