This pilot study is to assess the efficacy and safety of BP1.4979 15 mg BID in female patients with moderate to severe binge eating disorder (BED), as defined according to DSM-5 guidelines.
First clinical study to assess the effect of the BP1.4979 on BED in female patients over an 8 week-tretament period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
67
2 tablets 15 mg of BP1.4979 per day
2 tablets of placebo per day
Nutrition Department, La Pitié Salpêtrière Hospital
Paris, France
Binge Eating episodes per week
Number of Binge Eating episodes per week as measured during baseline and at the end of the treatment period
Time frame: 8 weeks
Binge Eating days per week
Number of Binge Eating days per week as measured during baseline and at the end of the treatment period
Time frame: 8 weeks
Quality of Life improvement (CGI-I)
Quality of life as per assessment on the Clinical Global Improvement (CGI-I) scale measured at randomization and at the end of the treatment period. The CGI is a 7-point scale that requires the clinician to assessment of the patient's illness at the beginning of the intervention (Baseline state) and rated as: 1, Normal, not at all ill; 2, Borderline mentally ill; 3, Mildly ill; 4, Moderately ill; 5, Markedly ill; 6, Severely ill; 7, Among the most extremely ill patients. The Clinical Global Impression-Improvement scale (CGI-I) is a 7 point scale that requires the clinician to assess how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1, very much improved; 2, much improved; 3, minimally improved; 4, no change; 5, minimally worse; 6, much worse; or 7, very much worse.
Time frame: 8 weeks
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