Reports_AtoE

Agomelatine

Report Synopsis
Study ID Study title Link
CL2-20098-040 Efficacy and safety of Agomelatine (25 mg with potential adjustment at 50 mg) given orally once a day for 12 weeks in out-patients with Generalised Anxiety Disorder.
CL3-20098-041 A study to determine the maintenance of efficacy of agomelatine (25 to 50 mg) in order to prevent relapses in out-patients with Major Depressive Disorder.   
CL3-20098-045 Efficacy and safety of agomelatine (25d amy g/with potential adjustment to 50 mg) given orally for 8 weeks in out-patients with severe Major Depressive Disorder.
CL3-20098-046 Efficacy of agomelatine (25mg/day with potential adjustment to 50 mg) given orally on rest/activity circadian rhythms in outpatients with Major Depressive Disorder.
CL3-20098-047 Efficacy and safety of agomelatine (25mg/day with potential adjustment at 50mg/day) given orally compared to placebo, in addition to a mood stabilizer in Bipolar I patients with a current major depressive episode.
CL3-20098-048 Efficacy of agomelatine (25 to 50 mg/day) given orally on quality of remission in elderly depressed patients, after a 12-week treatment period.
CL3-20098-050 Long-term efficacy and safety of agomelatine in non depressed out-patients with Generalized Anxiety Disorder
CL3-20098-056 Effects of agomelatine (25 to 50 mg/day) on sleep EEG parameters compared to escitalopram in patients with Major Depressive Disorder.
CL3-20098-060 Efficacy and safety of agomelatine (25mg/day with blinded potential adjustment to 50mg/day) versus escitalopram (10mg/day with blinded potential adjustment to 20mg/day) given orally for 12 weeks in non-depressed out-patients with severe Generalized Anxiety Disorder.
CL3-20098-062 Evaluation of efficacy and clinical benefit of agomelatine (25 to 50 mg/day) over 6-month treatment period in patients with Major Depressive Disorder.
CL3-20098-063 Efficacy of agomelatine (25 to 50 mg/day) given orally on improvement of subjective sleep in patients with Major Depressive Disorder.
CL2-20098-067 Effects of agomelatine (25 mg) given orally once a day for 7 days on cerebral activity measured by functional MRI during processing of emotional stimuli in patients with Major Depressive Disorder.
CL3-20098-069 Efficacy and safety of 3 dose regimens of agomelatine (10, 25, 25-50 mg) versus placebo given once a day for 6 weeks in out-patients suffering from moderate to severe Major Depressive Disorder.
CL3-20098-070 Efficacy and safety of agomelatine oral administration (25 to 50 mg/day) in elderly patients suffering from Major Depressive Disorder.
CL3-20098-071 Efficacy and safety of agomelatine (25 mg/day with potential blinded adjustment to 50 mg/day) for 12 weeks in non-depressed out-patients with Generalized Anxiety Disorder.
CL2-20098-072 Efficacy of agomelatine 25 mg/day (with possible increase to 50 mg/day after 8 weeks of treatment) given orally during 16 weeks in patients with Obsessive-Compulsive Disorder.
CL3-20098-073 Initiation of agomelatine after antidepressant treatment by SSRI or SNRI in outpatients suffering Major Depressive Disorder.
CL2-20098-075 Pharmacokinetics and safety of agomelatine in children (from 7 to less than 12 years) and adolescents (from 12 to less than 18 years) with Depressive or Anxiety Disorder. An open-labelled, multicenter, three-dose level, non-comparative study.
CL3-20098-080 Effects of agomelatine (25 to 50 mg/day) on circadian rhythms in patients with Major Depressive Disorder. An exploratory 6-week open, flexible dose, international multicentre, non comparative study.
CL3-20098-083 Early effect of agomelatine on general interest in outpatients with Major Depressive Disorder.
CL3-20098-087 Efficacy and safety of 2 doses of agomelatine (10 mg/day or 25 mg/day) versus placebo given orally for 12 weeks in non depressed out-patients with Generalized Anxiety Disorder. A 12-week randomised, double-blind, placebo-controlled, 3-arm parallel groups, international multicenter study.
CL3-20098-089 Efficacy and safety of agomelatine (25mg/day with blinded potential adjustment to 50mg/day) versus escitalopram (10mg/day with blinded potential adjustment to 20mg/day) given orally for 12 weeks in non-depressed out-patients with severe Generalized Anxiety Disorder.
DM4-20098-107 Response to VALDOXAN® and restoration of social rhythms in Major Depressive Disorder: VALDOXAN® DRhythm study.
DM4-20098-108 Clinical efficacy of VALDOXAN in everyday practice conditions (efficiency) in depressed patients, on a treatment-naive or switch basis. VALDOXAN D-CHANGE Study
DM4-20098-112 Clinical long-term effects of Valdoxan® (25 or 50 mg) in depressed patients. Valdoxan® D-EXTENSION Study
CL2-90098-005 Efficacy and safety of 2 doses of S 90098 (1 and 2mg/day), sublingual formulation for 8 weeks in out-patients with Major Depressive Disorder. An 8-week randomised, double-blind, fixed dose, international, multicentre, placebo-controlled study with parallel groups, followed by an extension double-blind treatment period for 16 weeks.
CL2-90098-009 Efficacy and safety of 3 doses (0.25, 0.5 and 1mg/day) of agomelatine sublingual administration over an 8-week treatment period, in out-patients with Major Depressive Disorder.

Benfluorex

Report Synopsis
Study ID Study title Link
CL3-00780-148 A one-year multicentre, international, randomised, double-blind study with comparison of benfluorex (150 mg od to 150 mg tid) versus pioglitazone (30 mg od to 45 mg od) in combination with sulfonylurea administered orally for the treatment of type 2 diabetes.
CL3-00780-150 International follow-up study, after the investigational drug exposure in diabetic patients previously included in the REGULATE trial (benfluorex versus pioglitazone).