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

Conditions: Attention Deficit/Hyperactivity Disorder (AD/HD) in adults

Registration Number: EUCTR2005-005012-25-BE

Lead Sponsor: BIOPROJET

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 20

Inclusion Criteria

- 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
F.1.3.1 Number of subjects for this age range

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), 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

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 (ADHD) 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 scale-scores AND a diminution of, at least, 2 points in ICG-Improvement scale<br>

Secondary Outcome Measures