Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
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This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2302E)
Change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17) [ Time Frame: 8 weeks ]
Secondary Outcome Measures
To evaluate the 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 ]
To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17 [ Time Frame: 8 weeks ]
To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8 [ Time Frame: 8 weeks ]
To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17 [ Time Frame: 8 weeks ]
To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8 [ Time Frame: 8 weeks ]
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Ages Eligible for Study:
18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
HAM-D17 total score > or = 22 at Screening and Baseline
CGI-Severity score > or = 4 at Screening and Baseline
Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase
History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
Any current Axis I disorder other than major depressive disorder 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
Female patients of childbearing potential who are not using effective contraception
Other protocol-defined inclusion/exclusion criteria may apply