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Clinical Trials/NCT00730249
NCT00730249
Completed
Phase 3

Quality Assurance of Administering Methylphenidate in Adults With ADHD

Medice Arzneimittel Pütter GmbH & Co KG11 sites in 1 country150 target enrollmentSeptember 2008
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ConditionsAttention Deficit Hyperactivity Disorder
InterventionsPlacebomethylphenidate hydrochloride
Drugsmethylphenidate hydrochloridePlacebo

Overview

Phase
Phase 3
Intervention
Placebo
Conditions
Attention Deficit Hyperactivity Disorder
Sponsor
Medice Arzneimittel Pütter GmbH & Co KG
Enrollment
150
Locations
11
Primary Endpoint
Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6)
Status
Completed
Last Updated
16 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

Brief Summary

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

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
January 2010
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Arms & Interventions

2

Intervention: Placebo

1

Intervention: methylphenidate hydrochloride

Outcomes

Primary Outcomes

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

  • CAARS-Self-Report: Long Version (CAARS-S:L)(20 weeks)

Study Sites (11)

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