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Completed

NCT Number: NCT00730249

Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA

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

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Key information

Conditions

Attention Deficit Hyperactivity Disorder Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Praxis Johannes Fuhr, Bad Wildungen, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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
  • SGOT and/or SGPT > 2 x upper norm-range
  • pathological ECG-finding
  • QTc > 450 msec in male, QTc > 470 msec in female
  • high blood pressure (anamnesis or blood pressure > 140/90 mm Hg at screening)
  • known acclusive arterial disease
  • angina pectoris (anamnesis or ECG-finding)
  • cardiac arrhythmias (anamnesis or ECG-finding)
  • KHK (anamnesis or ECG-finding)
  • post heart-attack status (anamnesis or ECG-finding)
  • post stroke status
  • known elevated intra-ocular pressure
  • known enlarged prostates
  • latent and manifest hyperthyreosis
  • TSH < lower norm-range
  • patient with a terminal disease (e.g. cancer)
  • 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 (contraceptives, intrauterine device , no sexual intercourse)
  • pregnancy (positive pregnancy test) or lactation period

Treatment and study plan

Methylphenidate Hydrochloride

Drug

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

Other names: Medikinet retard

Placebo

Drug

twice daily according to an individual titration schedule

Primary outcomes

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

    Time frame: 20 weeks

Secondary outcomes

  1. CAARS-Self-Report: Long Version (CAARS-S:L)

    Time frame: 20 weeks

Sponsors and collaborators

Lead sponsor

Medice Arzneimittel Pütter GmbH & Co KG

Industry

Registry information

Official study title

Quality Assurance of Administering Methylphenidate in Adults With ADHD

Acronym: QUMEA

Important dates

Study start
2008
Primary completion
2010
First posted
Aug 8, 2008
Registry last updated
Jan 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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