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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-09-30

Brief Summary

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

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Detailed Description

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Conditions

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Attention Deficit Hyperactivity Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type ACTIVE_COMPARATOR

methylphenidate hydrochloride

Intervention Type DRUG

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

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

twice daily according to an individual titration schedule

Interventions

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methylphenidate hydrochloride

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

Intervention Type DRUG

Placebo

twice daily according to an individual titration schedule

Intervention Type DRUG

Other Intervention Names

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Medikinet retard

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No