Overview

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

Status:
Completed
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novartis Pharmaceuticals
Treatments:
S 20098
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