Health Condition 1: null- Major Depressive Disorder
Conditions
Interventions
Intervention1: Agomelatine: one tablet once daily at bed time for 8 weeks
Control Intervention1: Placebo: one tablet once daily at bed time for 8 weeks
Sponsors
Precise Chemipharma Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: All subjects with duly filled and signed in ICFs [Informed Consent Forms]. Adult males or females, age 18-65 years (inclusive). Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria. HAM-D17 total score less than or 22 at Screening and Baseline. CGI-Severity score less than or 4 at Screening and Baseline. Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase.
Exclusion criteria
Exclusion criteria: Patients with seasonal patterns, psychotic features or post-partum onset. Patients with other types of depression or psychiatric conditions (including bipolar I and II or dysthymic disorders) and those who displayed marked suicidal intent or known suicidal tendencies. Patients undergoing electroconvulsive treatment, insight-oriented or structured psychotherapy during the 3 months prior to assessment. Patients undergoing light therapy during the 2 weeks before assessment. Patients who are otherwise eligible but who had not derived clinical benefit from two adequate antidepressant trials for the current episode, or from a previous trial of Agomelatine, will also be excluded. History of 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary efficacy parameter is the evaluation of MDD symptom score in the second week and at the end of the trial.Timepoint: second week | — |
Secondary
| Measure | Time frame |
|---|---|
| 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]Timepoint: 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]Timepoint: 8 weeks;To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of more than or 7 on the HAM-D17 [Time Frame: 8 week]Timepoint: 8 weeks;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 ]Timepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactDr Devendra Save
Outcome results
None listed