Etude en simple aveugle évaluant l'efficacité et la tolérance du BF 2.649 dans le trouble de l'attention/hyperactivité de l'adulte
- Conditions
- Attention Deficit / Hyperactivity Disorder (AD/HD) in adults
- Registration Number
- EUCTR2005-005012-25-FR
- Lead Sponsor
- BIOPROJET
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 35
- 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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method