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

Novartis

Status and phase: Completed; Phase 3

Conditions: Major Depressive Disorder

Treatments: Drug: Placebo; Drug: Agomelatine (AGO178C)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01110889

CAGO178C2301

Details and patient eligibility

About

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.

Enrollment: 582 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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582 participants in 3 patient groups, including a placebo group

AGO178C 0.5 mg /day

Experimental group

Treatment:

Drug: Agomelatine (AGO178C)

Drug: Agomelatine (AGO178C)

AGO178C 1 mg / day

Experimental group

Treatment:

Drug: Agomelatine (AGO178C)

Drug: Agomelatine (AGO178C)

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo