Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
An 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)
Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale [ Time Frame: Baseline and 8 weeks ]
Secondary Outcome Measures
Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8 [ Time Frame: 8 weeks ]
Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint [ Time Frame: 8 weeks ]
Proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale [ Time Frame: 8 weeks ]
Proportion of patients who achieve remission [ Time Frame: 8 weeks ]
Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale. [ Time Frame: 8 weeks ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
Current episode ≥4 weeks.
CGI-Severity score ≥4 at Screening and Baseline.
History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder (current or during previous one year), obsessive-compulsive disorder.
Any other current Axis I disorder other than MDD which is the focus of treatment.
Substance or alcohol abuse in the last 30 days, dependence in the last 6 months.
Concomitant psychotropic medication, including herbal preparations and melatonin.
Psychotherapy of any type.
Prior exposure to agomelatine.
Female patients of childbearing potential who are not using effective contraception.
Other protocol-defined inclusion/exclusion criteria may apply