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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medice Arzneimittel Pütter GmbH & Co KG
• Treatments: Central Nervous System Stimulants; Methylphenidate

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

• 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