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

December 16, 2020 updated by: Novartis Pharmaceuticals

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

837

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • Ponce, Puerto Rico, 00731
        • Centro de Investigacion Clinica Psiquiatrica
      • San Juan, Puerto Rico, 00918
        • INSPIRA Clinical Research
      • San Juan, Puerto Rico, 00907
        • Dharma Institute and Research Center
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Arizona
      • Glendale, Arizona, United States, 85308
        • Advanced Research Associates
      • Scottsdale, Arizona, United States, 85254
        • Southwest Health Ltd dba The Mollen Clinic
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Study Centers, LLC
    • California
      • Beverly Hills, California, United States, 90210
        • Southwestern Research Institute
      • Cerritos, California, United States, 90703
        • Comprehensive Neuroscience
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research, Inc
      • Garden Grove, California, United States, 92845
        • Collaborative NeuroScience Network
      • Newport Beach, California, United States, 92660
        • Pharmacology Research Institute
      • Orange, California, United States, 92868
        • Pacific Clinical Research Medical Group
      • San Diego, California, United States, 92103
        • University of California, San Diego Medical Center
      • San Diego, California, United States, 92102
        • CNRI-San Diego, LLC
      • Santa Ana, California, United States, 92701
        • Neuropsychiatric Research Center of Orange County
      • Temecula, California, United States, 92591
        • Viking Clinical Research Center
      • Torrance, California, United States, 90502
        • Collaborative Neuroscience
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Denver, Colorado, United States, 80209
        • Western Affiliated Research Institute
    • Connecticut
      • Middletown, Connecticut, United States, 06457
        • Middlesex Hospital
    • Florida
      • Altamonte Springs, Florida, United States, 32701
        • Clinical Studies
      • Bradenton, Florida, United States, 34208
        • Florida Clinical Research Center, LLC
      • Coral Gables, Florida, United States, 33134
        • Arocha Research Center
      • Coral Springs, Florida, United States, 33067
        • CNS Clinical Research
      • Destin, Florida, United States, 32541
        • Sjs Clinical Research
      • Hallandale Beach, Florida, United States, 33009
        • MD Clinical
      • Jacksonville, Florida, United States, 32216
        • CNS Healthcare
      • Maitland, Florida, United States, 34201
        • Florida Clinical Research Center
      • Orlando, Florida, United States, 32806
        • CNS Healthcare
      • Pompano Beach, Florida, United States, 33064
        • Quantum Lab. at N. Broward Memory Disorder Center
      • Saint Petersburg, Florida, United States, 33716
        • Comprehensive NeuroScience, Inc.
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
      • West Palm Beach, Florida, United States, 33407
        • Janus Center For Psychiatric Research
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
      • Atlanta, Georgia, United States, 30306
        • Emory University
      • Marietta, Georgia, United States, 30060
        • Northwest Behavioral Research Center
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Hawaii Clinical Research Center
    • Illinois
      • Hoffman Estates, Illinois, United States, 60169
        • Alexian Brothers Center for Psychiatric Research
      • Joliet, Illinois, United States, 60435
        • Joliet Center for Clinical Research
      • Libertyville, Illinois, United States, 60048
        • Capstone Clinical Research
      • Skokie, Illinois, United States, 60076
        • Rush University Medical Center
    • Indiana
      • Newburgh, Indiana, United States, 47630
        • Deaconess Clinic Gateway
    • Maryland
      • Pikesville, Maryland, United States, 21208
        • PharmaSite Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Boston Clinical Trials
      • Watertown, Massachusetts, United States, 02472
        • Mount Auburn Medical Associates
      • Weymouth, Massachusetts, United States, 02190
        • Coastal Research Associates
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Michigan State University
      • Grand Rapids, Michigan, United States, 49548
        • Pine Rest Christian Mental Health Services
      • Rochester Hills, Michigan, United States, 48307
        • Rochester Center for Behavioral Medicine
    • Missouri
      • Gladstone, Missouri, United States, 64118
        • Comprehensive Psychiatric Associates
    • New Jersey
      • Piscataway, New Jersey, United States, 08854
        • Robert Wood Johnson Medical School
      • Toms River, New Jersey, United States, 08755
        • Bio Behavioral Health
      • Willingboro, New Jersey, United States, 08046
        • CRI Worldwide
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Albuquerque Neuroscience
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center
      • Brooklyn, New York, United States, 11235
        • Social Psychiatry Research, Inc./ SPRI
      • Cedarhurst, New York, United States, 11516
        • Neurobehavioral Research, Inc.
      • New York, New York, United States, 10128
        • The Medical Research Network, LLC
      • New York, New York, United States, 10021
        • Eastside Comprehensive Medical Service
      • New York, New York, United States, 10023
        • Medical & Behavior Health Research
      • Staten Island, New York, United States, 10312
        • Richmond Behavioral Associates
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • PharmQuest
      • Raleigh, North Carolina, United States, 27607
        • Zarzar Psychiatric Associates
      • Winston-Salem, North Carolina, United States, 27103
        • Piedmont Medical Research Associates, Inc.
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Odyssey Research Services
    • Ohio
      • Canton, Ohio, United States, 44718
        • Neuro Behavioral Clinical Research
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44130
        • North Star Medical Research
      • Columbus, Ohio, United States, 43210
        • The Ohio State Universtiy - Harding Hospital
      • Toledo, Ohio, United States, 43623
        • Neurology & Neuroscience Center Of Ohio
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73116
        • Cutting Edge Research
      • Oklahoma City, Oklahoma, United States, 73112
        • SP Research
      • Oklahoma City, Oklahoma, United States, 73103
        • IPS Research
    • Oregon
      • Medford, Oregon, United States, 97504
        • Sunstone Medical Research, LLC
      • Portland, Oregon, United States, 97210
        • Oregon Center for Clinical Investigations
      • Portland, Oregon, United States, 97210
        • Summit Research
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center for Clinical Research
      • Media, Pennsylvania, United States, 19063
        • Suburban Research Associates
      • Philadelphia, Pennsylvania, United States, 19139
        • CRI Worldwide, LLC
    • South Carolina
      • Charleston, South Carolina, United States, 29406
        • Medical University of South Carolina
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Clinical Neuroscience Solutions, Inc.
      • Memphis, Tennessee, United States, 38119
        • Research Strategies of Memphis
      • Nashville, Tennessee, United States, 37203
        • Clinical Research Associates
    • Texas
      • Arlington, Texas, United States, 76011
        • Millwood Hospital
      • Dallas, Texas, United States, 75231
        • FutureSearch Trials of Dallas
      • DeSoto, Texas, United States, 75115
        • InSite Clinical Research
      • Houston, Texas, United States, 77081
        • Texas Center for Drug Development
      • Houston, Texas, United States, 77007
        • Bayou City Research Limited
      • Houston, Texas, United States, 77008
        • Claghorn Lesem Research Clinic, Inc.
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trials
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Radiant Research
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Mood Disorders Clinic
    • Virginia
      • Richmond, Virginia, United States, 23230
        • Alliance Research Group, LLC
    • Washington
      • Bellevue, Washington, United States, 98007
        • Northwest Clinical Research Center
      • Spokane, Washington, United States, 99204
        • Frontier Institute
    • Wisconsin
      • Waukesha, Wisconsin, United States, 53188
        • Independent Psychiatric Consultants

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Agomelatine (AGO178) 0.5 mg
Drug: AGO178
Experimental: Agomelatine (AGO178) 1 mg
Drug: AGO178

What is the study measuring?

Primary Outcome Measures

Outcome 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
Time Frame: 52 weeks
52 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
Time Frame: Week 6, 8, 12, 28, 36 and 52
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
Time Frame: 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
Time Frame: Week 52
Week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

June 30, 2010

First Submitted That Met QC Criteria

July 1, 2010

First Posted (Estimate)

July 2, 2010

Study Record Updates

Last Update Posted (Actual)

December 24, 2020

Last Update Submitted That Met QC Criteria

December 16, 2020

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAGO178C2399

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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