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

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

Official Title
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Quality Assurance of Administering Methylphenidate in Adults With ADHD

Conditions
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Attention Deficit Hyperactivity Disorder

Intervention / Treatment
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* Drug: methylphenidate hydrochloride
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: methylphenidate hydrochloride<br>* sustained release, twice daily, dosage according to an individual titration schedule<br>* Other names: Medikinet retard;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* twice daily according to an individual titration schedule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wender-Reimherr Adult Attention Deficit Disorder Scale (WRAADDS) in last study-week (Placebo vs. Verum, double-blind phase, week 6) |  | 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAARS-Self-Report: Long Version (CAARS-S:L) |  | 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADHD, Attention Deficit Hyperactivity Disorder, adult, methylphenidate hydrochloride, Medikinet retard, controlled clinical trial, safety, randomized, double-blind, placebo-controlled trial, treatment, central nervous system stimulants, therapeutic uses