Major Depressive DisorderPhase 3NCT01156415
Open-label Long Term (52 Weeks) Safety and Tolerability of Agomelatine Sublingual Tablets in Major Depressive Disorder (MDD)
A Phase 3 study testing AGO178 in people with Major Depressive Disorder, run by Novartis Pharmaceuticals at 98 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 71 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- AGO178
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 837 participants
- Where
- 98 sitesin 2 countries
- Study dates
- Jun 2010to Oct 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 71 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
- 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.
Trial locations and contacts
98 sites in 2 countries.
98 sites in 2 countries
United States95 sites
Neurological Associates Of Albany
Albany, New York, 12208
Albuquerque Neuroscience
Albuquerque, New Mexico, 87109
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
Clinical Studies
Altamonte Springs, Florida, 32701
Millwood Hospital
Arlington, Texas, 76011
Emory University
Atlanta, Georgia, 30306
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
University of Colorado
Aurora, Colorado, 80045
Northwest Clinical Research Center
Bellevue, Washington, 98007
Southwestern Research Institute
Beverly Hills, California, 90210
University of Alabama at Birmingham
Birmingham, Alabama, 35294
Boston Clinical Trials
Boston, Massachusetts, 02135
Florida Clinical Research Center, LLC
Bradenton, Florida, 34208
Social Psychiatry Research, Inc./ SPRI
Brooklyn, New York, 11235
Neuro Behavioral Clinical Research
Canton, Ohio, 44718
Neurobehavioral Research, Inc.
Cedarhurst, New York, 11516
Comprehensive Neuroscience
Cerritos, California, 90703
Medical University of South Carolina
Charleston, South Carolina, 29406
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219
North Star Medical Research
Cleveland, Ohio, 44130
The Ohio State Universtiy - Harding Hospital
Columbus, Ohio, 43210
Arocha Research Center
Coral Gables, Florida, 33134
CNS Clinical Research
Coral Springs, Florida, 33067
ATP Clinical Research, Inc
Costa Mesa, California, 92626
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Western Affiliated Research Institute
Denver, Colorado, 80209
InSite Clinical Research
DeSoto, Texas, 75115
Sjs Clinical Research
Destin, Florida, 32541
Michigan State University
East Lansing, Michigan, 48824
Odyssey Research Services
Fargo, North Dakota, 58104
Collaborative Neuroscience Network
Garden Grove, California, 92845
Comprehensive Psychiatric Associates
Gladstone, Missouri, 64118
Advanced Research Associates
Glendale, Arizona, 85308
Pine Rest Christian Mental Health Services
Grand Rapids, Michigan, 49548
Pharmquest
Greensboro, North Carolina, 27408
MD Clinical
Hallandale, Florida, 33009
Alexian Brothers Center for Psychiatric Research
Hoffman Estates, Illinois, 60169
Hawaii Clinical Research Center
Honolulu, Hawaii, 96813
Bayou City Research Limited
Houston, Texas, 77007
Claghorn Lesem Research Clinic, Inc.
Houston, Texas, 77008
Texas Center for Drug Development
Houston, Texas, 77081
CNS Healthcare
Jacksonville, Florida, 32216
Joliet Center for Clinical Research
Joliet, Illinois, 60435
Capstone Clinical Research
Libertyville, Illinois, 60048
Clinical Study Centers, LLC
Little Rock, Arkansas, 72205
Florida Clinical Research Center
Maitland, Florida, 34201
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Sunstone Medical Research, LLC
Medford, Oregon, 97504
Suburban Research Associates
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
Research Strategies of Memphis
Memphis, Tennessee, 38119
Middlesex Hospital
Middletown, Connecticut, 06457
Clinical Research Associates
Nashville, Tennessee, 37203
Eastside Comprehensive Medical Service
New York, New York, 10021
Medical & Behavior Health Research
New York, New York, 10023
The Medical Research Network, LLC
New York, New York, 10128
Deaconess Clinic Gateway
Newburgh, Indiana, 47630
Pharmacology Research Institute
Newport Beach, California, 92660
IPS Research
Oklahoma City, Oklahoma, 73103
SP Research
Oklahoma City, Oklahoma, 73112
Cutting Edge Research
Oklahoma City, Oklahoma, 73116
Pacific Clinical Research Medical Group
Orange, California, 92868
CNS Healthcare
Orlando, Florida, 32806
CRI Worldwide, LLC
Philadelphia, Pennsylvania, 19139
Pharmasite Research
Pikesville, Maryland, 21208
Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
Quantum Lab. at N. Broward Memory Disorder Center
Pompano Beach, Florida, 33064
Oregon Center for Clinical Investigations
Portland, Oregon, 97210
Summit Research
Portland, Oregon, 97210
Zarzar Psychiatric Associates
Raleigh, North Carolina, 27607
Alliance Research Group, LLC
Richmond, Virginia, 23230
Rochester Center for Behavioral Medicine
Rochester Hills, Michigan, 48307
Radiant Research
Salt Lake City, Utah, 84107
University of Utah Mood Disorders Clinic
Salt Lake City, Utah, 84132
CNRI-San Diego, LLC
San Diego, California, 92102
University of California, San Diego Medical Center
San Diego, California, 92103
Neuropsychiatric Research Center of Orange County
Santa Ana, California, 92701
Southwest Health Ltd dba The Mollen Clinic
Scottsdale, Arizona, 85254
Rush University Medical Center
Skokie, Illinois, 60076
Miami Research Associates
South Miami, Florida, 33143
Frontier Institute
Spokane, Washington, 99204
Comprehensive NeuroScience, Inc.
St. Petersburg, Florida, 33716
Richmond Behavioral Associates
Staten Island, New York, 10312
Viking Clinical Research Center
Temecula, California, 92591
Montefiore Medical Center
The Bronx, New York, 10467
Neurology & Neuroscience Center of Ohio
Toledo, Ohio, 43623
Bio Behavioral Health
Toms River, New Jersey, 08755
Collaborative Neuroscience
Torrance, California, 90502
Mount Auburn Medical Associates
Watertown, Massachusetts, 02472
Independent Psychiatric Consultants
Waukesha, Wisconsin, 53188
Janus Center for Psychiatric Research
West Palm Beach, Florida, 33407
Coastal Research Associates
Weymouth, Massachusetts, 02190
Grayline Clinical Drug Trials
Wichita Falls, Texas, 76309
CRI Worldwide
Willingboro, New Jersey, 08046
Piedmont Medical Research Associates, Inc.
Winston-Salem, North Carolina, 27103
Puerto Rico3 sites
Centro de Investigacion Clinica Psiquiatrica
Ponce, 00731
Dharma Institute and Research Center
San Juan, 00907
INSPIRA Clinical Research
San Juan, 00918
About this study
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)
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.
- Conditions
- Major Depressive Disorder
- Being tested
- AGO178
- Keywords
- agomelatine, Major Depressive Disorder, MDD, depression
- Medical subject headings
- Depressive Disorder, Major, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AGO178Drug
AGO178Drug
| Study group | Role | What they receive |
|---|---|---|
| Agomelatine (AGO178) 0.5 mg | Experimental | Not described Receives: Drug: AGO178 |
| Agomelatine (AGO178) 1 mg | Experimental | Not described Receives: Drug: AGO178 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reports of adverse events, serious adverse events, changes in laboratory values, ECGs, vital signs, physical examination, and Columbia Suicidality Severity Rating Scale
Measured: 52 weeks
Secondary outcomes (4)
Change from Baseline to Week 6, 8, 12, 28, 36 and 52 on total score of the Hamilton Depression Rating Scale
Measured: 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
Measured: 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
Measured: 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
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2011
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 837 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01156415
- Sponsor's protocol ID
- CAGO178C2399
- Status last verified
- Mar 2013
- First submitted
- 30 Jun 2010
- Last updated
- 24 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01156415
- Acronym / sponsor ID
- CAGO178C2399
- Conditions
- Major Depressive Disorder
- Keywords
- agomelatine, Major Depressive Disorder, MDD, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 837 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Agomelatine (AGO178) 0.5 mg | Experimental | Drug: AGO178 |
| Agomelatine (AGO178) 1 mg | Experimental | Drug: AGO178 |
Who may qualify
- Ages
- 18 to 71 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
- Male and female adults, 18 through 70 years of age, inclusive.
- Diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
Key exclusion criteria (8 listed)
- 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.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AGO178 | Drug | Agomelatine (AGO178) 1 mg |
| AGO178 | Drug | Agomelatine (AGO178) 0.5 mg |
Primary outcome
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
4 secondary outcomes
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
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
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
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
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Results for CAGO178C2399 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
98 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AGO178 in people with Major Depressive Disorder, run by Novartis Pharmaceuticals at 98 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 98 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2020.