Major Depressive Disorder
Conditions
Keywords
agomelatine, Major Depressive Disorder, MDD, depression
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.
Interventions
DRUGAGO178
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 71 Years
Healthy volunteers
No
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: * Male and female adults, 18 through 70 years of age, inclusive. * 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
Key
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
Puerto Rico, United States
Outcome results
None listed