Single blind study to assess the efficacy and tolerance of BF 2.649 in adults suffering from Attention Deficit/Hyperactivity Disorder

BIOPROJET0 sites20 target enrollmentNovember 24, 2005

Overview

No summary available.

Registry

who.int

Start Date

November 24, 2005

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•\- Male or Female aged from 18 to 65 years old
•\- Ambulatory patients suffering from Attention Deficit / Hyperactivity Disorder (according to DSM\-IV criteria)
•\- No specific medications for ADHD treatment
•\- Score superior to 46 on WURS scale
•\- Informed written consent
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range
•F.1\.3 Elderly (\>\=65 years) no

•Psychiatric disorders:
•\- All psychiatric diseases other than ADHD
•Psychotropic medications:
•\- Any prescription of Atomoxetine, anti\-depressants, anti\-psychotics, mood stabilizers during the previous 4 weeks,
•\- Any psychostimulants (methylphenidate), benzodiazepine, zolpidem, zopiclone, zaleplon and any medication with psychic effects in the past 2 weeks.
•\- Severe systemic illnesses and any illness, which according to the investigator's judgement, will expose the patient to an excessive risk
•\- ECG: auriculo\-ventricular block with PR \> 200 MS and/or QTc \> 450 ms
•\- Biological tests: values considered to be abnormal by the investigator