Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder (MDD)

Novartis Pharmaceuticals589 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

589

Conditions

Major Depressive Disorder

Interventions

Agomelatine (AGO178C)DRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (45)

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

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

Data from ClinicalTrials.gov

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