Attention Deficit / Hyperactivity Disorder (AD/HD) in adults
Conditions
Interventions
Product Name: BF 2.649
Product Code: BF 2.649
Pharmaceutical Form: Tablet
Current Sponsor code: BF 2.649
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10- 20 mg-
Sponsors
BIOPROJET
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and 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 F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the efficacy of BF 2.649 on symptoms from Attention Deficit / Hyperactivity disorder (AD/HD) in adults;Secondary Objective: To evaluate the safety of BF 2.649 and its effects on vigilance and wakefulness;Primary end point(s): Clinical response after 4 weeks of treatment > or equal to 30 % in ADHD scales-scores AND a diminution of, at least, 2 points in ICG-Improvement scale | — |
Countries
Belgium, France
Outcome results
None listed