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

Study Overview
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Brief Summary
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Investigation of efficacy and tolerability of extended-release MPD in adults with ADHD, compared with a placebo, and to acquire knowledge through long-term observation of adults

Official Title
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Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for 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 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

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, 10 mg capsule 1-3 capsules twice daily according to an individual titration schedule<br>* Other names: Medikinet retard;|
| Placebo Comparator: 2<br> | Drug: Placebo<br>* 10 mg capsule 1-3 capsules 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 |
| --- | --- | --- |
| German validated version of the WRAADDS: Wender-Reimherr-Interview (WRI) |  | Week 24 | 

Secondary Outcome Measures

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

 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, long-term observation, controlled clinical trial, safety, randomized, double-blind, placebo-controlled trial, treatment, central nervous system stimulants, therapeutic uses