A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)

Novartis Pharmaceuticals97 sites in 1 country837 target enrollmentJune 2010

ConditionsMajor Depressive Disorder

InterventionsAGO178

DrugsAGO178

Overview

Phase: Phase 3
Intervention: AGO178
Conditions: Major Depressive Disorder
Sponsor: Novartis Pharmaceuticals
Enrollment: 837
Locations: 97
Primary Endpoint: Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale
Status: Terminated
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2010

End Date

October 2011

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

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 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.

Arms & Interventions

Agomelatine (AGO178) 0.5 mg

Intervention: AGO178

Agomelatine (AGO178) 1 mg

Intervention: AGO178

Outcomes

Primary Outcomes

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

Time Frame: 52 weeks

Secondary Outcomes

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)