Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)

Phase 3

Terminated

Brief Summary: The study will assess safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine (AGO178) in patients with Major Depressive Disorder over a 52-week open-label phase.

Cohort I is restricted to include patients who have completed a previous Novartis agomelatine (178C) Double-blind study.

Cohort II will include de-novo patients (those who did not participate in a previous agomelatine 178C study) and will only be open for a limited time span ranging from approximately June to Sept 2010, at which point this cohort II will be closed to enrollment.

Recruitment & Eligibility

Inclusion Criteria

Key Inclusion Criteria Cohort I:

Documentation of completion of a Novartis AGO178C Double-blind Study in MDD patients.
Male and female adults, 18 through 71 years of age, inclusive (i.e., same age range as for Double-blind Study, but with upper age limit increased by 1-year to accommodate patients whose age increased during the Double-blind Study).
Female patients should continue to use effective contraception as defined in double-blind study protocol.

Inclusion Criteria:

Key Inclusion criteria Cohort II:

Exclusion Criteria

Key Exclusion Criteria Cohort I:

Concomitant use of fluvoxamine.
Any significant medical condition that emerged during Double-blind Phase of a previous study, which may interfere with study participation and/or study assessments as assessed by the investigator.

Exclusion Criteria:

Key Exclusion criteria Cohort II:

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.
Prior exposure to agomelatine.
Female patients of childbearing potential who are not using effective contraception.

Other protocol-defined inclusion/exclusion criteria may apply.

Arm && Interventions

Group	Intervention	Description
Agomelatine (AGO178) 0.5 mg	AGO178	-
Agomelatine (AGO178) 1 mg	AGO178	-

Primary Outcome Measures

Name	Time	Method
Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale	52 weeks

Secondary Outcome Measures

Name	Time	Method
Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale	Week 6, 8, 12, 28, 36 and 52
Proportion of patients who demonstrate clinical improvement at Week 6,8,12, 28,36 and 52, where improvement is defined by a score of 1 or 2 on the CGI-I scale	Week 6, 8, 12, 28, 36 and 52
Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52	Week 52
Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52	Week 52

Locations (97): University of Alabama at Birmingham
🇺🇸
Birmingham, Alabama, United States
Advanced Research Associates
🇺🇸
Glendale, Arizona, United States
Southwest Health Ltd dba The Mollen Clinic
🇺🇸
Scottsdale, Arizona, United States
Clinical Study Centers, LLC
🇺🇸
Little Rock, Arkansas, United States
Southwestern Research Institute
🇺🇸
Beverly Hills, California, United States
Comprehensive Neuroscience
🇺🇸
Cerritos, California, United States
ATP Clinical Research, Inc
🇺🇸
Costa Mesa, California, United States
Collaborative Neuroscience Network
🇺🇸
Garden Grove, California, United States
Pharmacology Research Institute
🇺🇸
Newport Beach, California, United States
Pacific Clinical Research Medical Group
🇺🇸
Orange, California, United States
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University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States