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

Primary Purpose

Major Depressive Disorder

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
AGO178
AGO178
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring agomelatine, Major Depressive Disorder, MDD, depression

Eligibility Criteria

18 Years - 71 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Other protocol-defined inclusion/exclusion criteria may apply.

Sites / Locations

  • University of Alabama at Birmingham
  • Advanced Research Associates
  • Southwest Health Ltd dba The Mollen Clinic
  • Clinical Study Centers, LLC
  • Southwestern Research Institute
  • Comprehensive Neuroscience
  • ATP Clinical Research, Inc
  • Collaborative Neuroscience Network
  • Pharmacology Research Institute
  • Pacific Clinical Research Medical Group
  • CNRI-San Diego, LLC
  • University of California, San Diego Medical Center
  • Neuropsychiatric Research Center of Orange County
  • Viking Clinical Research Center
  • Collaborative Neuroscience
  • University of Colorado
  • Western Affiliated Research Institute
  • Middlesex Hospital
  • Clinical Studies
  • Florida Clinical Research Center, LLC
  • Arocha Research Center
  • CNS Clinical Research
  • Sjs Clinical Research
  • MD Clinical
  • CNS Healthcare
  • Florida Clinical Research Center
  • CNS Healthcare
  • Quantum Lab. at N. Broward Memory Disorder Center
  • Comprehensive NeuroScience, Inc.
  • Miami Research Associates
  • Janus Center for Psychiatric Research
  • Emory University
  • Atlanta Center for Medical Research
  • Northwest Behavioral Research Center
  • Hawaii Clinical Research Center
  • Alexian Brothers Center for Psychiatric Research
  • Joliet Center for Clinical Research
  • Capstone Clinical Research
  • Rush University Medical Center
  • Deaconess Clinic Gateway
  • Pharmasite Research
  • Boston Clinical Trials
  • Mount Auburn Medical Associates
  • Coastal Research Associates
  • Michigan State University
  • Pine Rest Christian Mental Health Services
  • Rochester Center for Behavioral Medicine
  • Comprehensive Psychiatric Associates
  • Robert Wood Johnson Medical School
  • Bio Behavioral Health
  • CRI Worldwide
  • Albuquerque Neuroscience
  • Neurological Associates Of Albany
  • Montefiore Medical Center
  • Social Psychiatry Research, Inc./ SPRI
  • Neurobehavioral Research, Inc.
  • Eastside Comprehensive Medical Service
  • Medical & Behavior Health Research
  • The Medical Research Network, LLC
  • Richmond Behavioral Associates
  • Pharmquest
  • Zarzar Psychiatric Associates
  • Piedmont Medical Research Associates, Inc.
  • Odyssey Research Services
  • Neuro Behavioral Clinical Research
  • University of Cincinnati Medical Center
  • North Star Medical Research
  • The Ohio State Universtiy - Harding Hospital
  • Neurology & Neuroscience Center of Ohio
  • IPS Research
  • SP Research
  • Cutting Edge Research
  • Sunstone Medical Research, LLC
  • Oregon Center for Clinical Investigations
  • Summit Research
  • Lehigh Center for Clinical Research
  • Suburban Research Associates
  • CRI Worldwide, LLC
  • Medical University of South Carolina
  • Clinical Neuroscience Solutions, Inc.
  • Research Strategies of Memphis
  • Clinical Research Associates
  • Millwood Hospital
  • FutureSearch Trials of Dallas
  • InSite Clinical Research
  • Bayou City Research Limited
  • Claghorn Lesem Research Clinic, Inc.
  • Texas Center for Drug Development
  • Grayline Clinical Drug Trials
  • Radiant Research
  • University of Utah Mood Disorders Clinic
  • Alliance Research Group, LLC
  • Northwest Clinical Research Center
  • Frontier Institute
  • Independent Psychiatric Consultants
  • Centro de Investigacion Clinica Psiquiatrica
  • Dharma Institute and Research Center
  • INSPIRA Clinical Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Agomelatine (AGO178) 0.5 mg

Agomelatine (AGO178) 1 mg

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale
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
Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at 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

Full Information

First Posted
June 30, 2010
Last Updated
December 16, 2020
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01156415
Brief Title
Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
Official Title
A 52-week, Multi-center, Open-label Study of the Safety and Tolerability of Agomelatine Sublingual Tablets in Patients With Major Depressive Disorder (MDD)
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
agomelatine, Major Depressive Disorder, MDD, depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
837 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Agomelatine (AGO178) 0.5 mg
Arm Type
Experimental
Arm Title
Agomelatine (AGO178) 1 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
AGO178
Intervention Type
Drug
Intervention Name(s)
AGO178
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale
Time Frame
Week 6, 8, 12, 28, 36 and 52
Title
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
Time Frame
Week 6, 8, 12, 28, 36 and 52
Title
Overall illness severity as measured by change from Baseline on CGI-S (Clinical Global Impression of severity scale) at week 52
Time Frame
Week 52
Title
Patients' ability to function in daily life as measured by change from Baseline on total score of Sheehan Disability Scale at week 52
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
71 Years
Accepts Healthy Volunteers
No
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. Other protocol-defined inclusion/exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Pharmaceuticals
Organizational Affiliation
Novartis Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Advanced Research Associates
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85308
Country
United States
Facility Name
Southwest Health Ltd dba The Mollen Clinic
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85254
Country
United States
Facility Name
Clinical Study Centers, LLC
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southwestern Research Institute
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Facility Name
Comprehensive Neuroscience
City
Cerritos
State/Province
California
ZIP/Postal Code
90703
Country
United States
Facility Name
ATP Clinical Research, Inc
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Garden Grove
State/Province
California
ZIP/Postal Code
92845
Country
United States
Facility Name
Pharmacology Research Institute
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Pacific Clinical Research Medical Group
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
CNRI-San Diego, LLC
City
San Diego
State/Province
California
ZIP/Postal Code
92102
Country
United States
Facility Name
University of California, San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Neuropsychiatric Research Center of Orange County
City
Santa Ana
State/Province
California
ZIP/Postal Code
92701
Country
United States
Facility Name
Viking Clinical Research Center
City
Temecula
State/Province
California
ZIP/Postal Code
92591
Country
United States
Facility Name
Collaborative Neuroscience
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Western Affiliated Research Institute
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Middlesex Hospital
City
Middletown
State/Province
Connecticut
ZIP/Postal Code
06457
Country
United States
Facility Name
Clinical Studies
City
Altamonte Springs
State/Province
Florida
ZIP/Postal Code
32701
Country
United States
Facility Name
Florida Clinical Research Center, LLC
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34208
Country
United States
Facility Name
Arocha Research Center
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
CNS Clinical Research
City
Coral Springs
State/Province
Florida
ZIP/Postal Code
33067
Country
United States
Facility Name
Sjs Clinical Research
City
Destin
State/Province
Florida
ZIP/Postal Code
32541
Country
United States
Facility Name
MD Clinical
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
CNS Healthcare
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Florida Clinical Research Center
City
Maitland
State/Province
Florida
ZIP/Postal Code
34201
Country
United States
Facility Name
CNS Healthcare
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Quantum Lab. at N. Broward Memory Disorder Center
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Comprehensive NeuroScience, Inc.
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33716
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Janus Center for Psychiatric Research
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30306
Country
United States
Facility Name
Atlanta Center for Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Northwest Behavioral Research Center
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Hawaii Clinical Research Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Alexian Brothers Center for Psychiatric Research
City
Hoffman Estates
State/Province
Illinois
ZIP/Postal Code
60169
Country
United States
Facility Name
Joliet Center for Clinical Research
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Capstone Clinical Research
City
Libertyville
State/Province
Illinois
ZIP/Postal Code
60048
Country
United States
Facility Name
Rush University Medical Center
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60076
Country
United States
Facility Name
Deaconess Clinic Gateway
City
Newburgh
State/Province
Indiana
ZIP/Postal Code
47630
Country
United States
Facility Name
Pharmasite Research
City
Pikesville
State/Province
Maryland
ZIP/Postal Code
21208
Country
United States
Facility Name
Boston Clinical Trials
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Mount Auburn Medical Associates
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
Country
United States
Facility Name
Coastal Research Associates
City
Weymouth
State/Province
Massachusetts
ZIP/Postal Code
02190
Country
United States
Facility Name
Michigan State University
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Pine Rest Christian Mental Health Services
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49548
Country
United States
Facility Name
Rochester Center for Behavioral Medicine
City
Rochester Hills
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Comprehensive Psychiatric Associates
City
Gladstone
State/Province
Missouri
ZIP/Postal Code
64118
Country
United States
Facility Name
Robert Wood Johnson Medical School
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Bio Behavioral Health
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States
Facility Name
CRI Worldwide
City
Willingboro
State/Province
New Jersey
ZIP/Postal Code
08046
Country
United States
Facility Name
Albuquerque Neuroscience
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87109
Country
United States
Facility Name
Neurological Associates Of Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Social Psychiatry Research, Inc./ SPRI
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
Neurobehavioral Research, Inc.
City
Cedarhurst
State/Province
New York
ZIP/Postal Code
11516
Country
United States
Facility Name
Eastside Comprehensive Medical Service
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Medical & Behavior Health Research
City
New York
State/Province
New York
ZIP/Postal Code
10023
Country
United States
Facility Name
The Medical Research Network, LLC
City
New York
State/Province
New York
ZIP/Postal Code
10128
Country
United States
Facility Name
Richmond Behavioral Associates
City
Staten Island
State/Province
New York
ZIP/Postal Code
10312
Country
United States
Facility Name
Pharmquest
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Zarzar Psychiatric Associates
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Piedmont Medical Research Associates, Inc.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Odyssey Research Services
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Neuro Behavioral Clinical Research
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
North Star Medical Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44130
Country
United States
Facility Name
The Ohio State Universtiy - Harding Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Neurology & Neuroscience Center of Ohio
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
IPS Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
SP Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cutting Edge Research
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Sunstone Medical Research, LLC
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
Oregon Center for Clinical Investigations
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Summit Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97210
Country
United States
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Suburban Research Associates
City
Media
State/Province
Pennsylvania
ZIP/Postal Code
19063
Country
United States
Facility Name
CRI Worldwide, LLC
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19139
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc.
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Research Strategies of Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
Clinical Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Millwood Hospital
City
Arlington
State/Province
Texas
ZIP/Postal Code
76011
Country
United States
Facility Name
FutureSearch Trials of Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
InSite Clinical Research
City
DeSoto
State/Province
Texas
ZIP/Postal Code
75115
Country
United States
Facility Name
Bayou City Research Limited
City
Houston
State/Province
Texas
ZIP/Postal Code
77007
Country
United States
Facility Name
Claghorn Lesem Research Clinic, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
Texas Center for Drug Development
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
Facility Name
Radiant Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
University of Utah Mood Disorders Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Alliance Research Group, LLC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23230
Country
United States
Facility Name
Northwest Clinical Research Center
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Frontier Institute
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Independent Psychiatric Consultants
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Centro de Investigacion Clinica Psiquiatrica
City
Ponce
ZIP/Postal Code
00731
Country
Puerto Rico
Facility Name
Dharma Institute and Research Center
City
San Juan
ZIP/Postal Code
00907
Country
Puerto Rico
Facility Name
INSPIRA Clinical Research
City
San Juan
ZIP/Postal Code
00918
Country
Puerto Rico

12. IPD Sharing Statement

Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=7243
Description
Results for CAGO178C2399 from the Novartis Clinical Trials website
URL
http://depressiondrugstudy.com
Description
Click here for more information about this study:

Learn more about this trial

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

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