A 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)

Novartis Pharmaceuticals45 sites in 2 countries589 target enrollmentMay 2010

ConditionsMajor Depressive Disorder

InterventionsAgomelatine (AGO178C)Placebo

DrugsAgomelatine (AGO178C)Placebo

Overview

Phase: Phase 3
Intervention: Agomelatine (AGO178C)
Conditions: Major Depressive Disorder
Sponsor: Novartis Pharmaceuticals
Enrollment: 589
Locations: 45
Primary Endpoint: Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

May 2010

End Date

June 2011

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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

Arms & Interventions

AGO178C 0.5 mg /day

Intervention: Agomelatine (AGO178C)

AGO178C 1 mg / day

Intervention: Agomelatine (AGO178C)

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

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 Outcomes

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(8 weeks)
Proportion of patients who achieve remission(8 weeks)
Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8(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(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.(8 weeks)