Status:
TERMINATED
Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18-71 years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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
- 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.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
837 Patients enrolled
Trial Details
Trial ID
NCT01156415
Start Date
June 1 2010
End Date
October 1 2011
Last Update
December 24 2020
Active Locations (98)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Advanced Research Associates
Glendale, Arizona, United States, 85308
3
Southwest Health Ltd dba The Mollen Clinic
Scottsdale, Arizona, United States, 85254
4
Clinical Study Centers, LLC
Little Rock, Arkansas, United States, 72205