Major Depressive DisorderPhase 3NCT01110889
Efficacy, Safety and Tolerability of Agomelatine Sublingual Tablets in the Treatment of Major Depressive Disorder
A Phase 3 study testing Agomelatine (AGO178C) in people with Major Depressive Disorder, run by Novartis Pharmaceuticals at 48 sites in 2 countries.
Trial summary
The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- Agomelatine (AGO178C)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 582 participants
- Where
- 48 sitesin 2 countries
- Study dates
- May 2010to Jul 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with 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
- 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.
- Concomitant psychotropic medication, including herbal preparations and melatonin.
- Psychotherapy of any type.
- 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
48 sites in 2 countries.
48 sites in 2 countries
United States47 sites
Neurological Associates Of Albany, P.C.
Albany, New York, 12208
Albuquerque Neuroscience
Albuquerque, New Mexico, 87109
Lehigh Center for Clinical Research
Allentown, Pennsylvania, 18104
Atlanta Center for Medical Research
Atlanta, Georgia, 30308
University of Colorado Denver
Aurora, Colorado, 80045
Northwest Clinical Research Center
Bellevue, Washington, 98007
Southwestern Research Institute
Beverly Hills, California, 90210
Birmingham Psychiatry
Birmingham, Alabama, 25226
Neurobehavioral Research Inc.
Cedarhurst, New York, 11516
Rush University Medical Center
Chicago, Illinois, 60612
The Ohio State University - Harding Hospital
Columbus, Ohio, 43210
KRK Medical Research
Dallas, Texas, 75230
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Midwest Clinical Research Center
Dayton, Ohio, 45417
Western Affiliated Research Institute
Denver, Colorado, 80204
InSite Clinical Research
DeSoto, Texas, 75115
Mountain West Clinical Trials
Eagle, Idaho, 83616
Pharmacology Research Institute
Encino, California, 91316
Odyssey Research Services
Fargo, North Dakota, 58104
Psychiatric Consultants
Franklin, Tennessee, 37067
Mood & Anxiety Research
Fresno, California, 93720
Comprehensive Psychiatric Associates
Gladstone, Missouri, 64114
Clinical Research Institute of South Florida
Hialeah, Florida, 33013
Hawaii Clinical Research Center
Honolulu, Hawaii, 96813
Texas Center for Drug Development
Houston, Texas, 77081
Florida Clinical Research Center LLC
Maitland, Florida, 32751
Northwest Behavioral Research Center
Marietta, Georgia, 30060
Sunstone Medical Research, LLC
Medford, Oregon, 97504
Clinical Trials Management
Metairie, Louisiana, 70006
Excell Research, Inc
Oceanside, California, 92056
IPS Research Company
Oklahoma City, Oklahoma, 73103
Cutting Edge Research
Oklahoma City, Oklahoma, 73116
CNS Healthcare
Orlando, Florida, 32806
Psychiatric Associates
Overland Park, Kansas, 66211
Broward Research Group
Pembroke Pines, Florida, 33026
Cnri-La, Llc
Pico Rivera, California, 90660
Quantum Lab. N. Broward Memory Disorder Center
Pompano Beach, Florida, 33064
CTT Clinical Trials Technology
Prairie Village, Kansas, 66206
Psychopharmacology Research Association of Princeton
Princeton, New Jersey, 08540
Alliance Research Group, LLC
Richmond, Virginia, 23230
Finger Lakes Clinical Research
Rochester, New York, 14618
CNRI San Diego
San Diego, California, 92102
University of California San Diego Medical Center
San Diego, California, 92103
Montefiore Medical Center
The Bronx, New York, 10467
Bio Behavioral Health
Toms River, New Jersey, 08755
Mount Auburn Medical Associates
Watertown, Massachusetts, 02472
Coastal Research Associates
Weymouth, Massachusetts, 02190
About this study
Official title: An 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)
The study will assess efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.
- Conditions
- Major Depressive Disorder
- Being tested
- Agomelatine (AGO178C), Placebo
- 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.
Agomelatine (AGO178C)Drug
Agomelatine (AGO178C)Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| AGO178C 0.5 mg /day | Experimental | Not described Receives: Drug: Agomelatine (AGO178C) |
| AGO178C 1 mg / day | Experimental | Not described Receives: Drug: Agomelatine (AGO178C) |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
Measured: Baseline and 8 weeks
Secondary outcomes (5)
Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8
Measured: 8 weeks
Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint
Measured: 8 weeks
Proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale
Measured: 8 weeks
Proportion of patients who achieve remission
Measured: 8 weeks
Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2010 (estimated)
- Study startMay 2010
- Primary completionJul 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 582 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
- NCT01110889
- Sponsor's protocol ID
- CAGO178C2301
- Status last verified
- Feb 2013
- First submitted
- 23 Apr 2010
- Last updated
- 23 Dec 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An 8-week, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy and Safety of Agomelatine 0.5 mg and 1 mg Sublingual Tablets Administered Once Daily in Patients With Major Depressive Disorder (MDD)
- ClinicalTrials.gov ID
- NCT01110889
- Acronym / sponsor ID
- CAGO178C2301
- Conditions
- Major Depressive Disorder
- Keywords
- Agomelatine, Major Depressive Disorder, MDD, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 582 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- First posted
- 27 Apr 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 efficacy, safety and tolerability of 0.5 mg/day and 1 mg/day of sublingual (under the tongue) formulation of agomelatine in patients with Major Depressive Disorder. This study includes an 8-week double-blind phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AGO178C 0.5 mg /day | Experimental | Drug: Agomelatine (AGO178C) |
| AGO178C 1 mg / day | Experimental | Drug: Agomelatine (AGO178C) |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with diagnosis of MDD, single or recurrent episode, according to DSM-IV criteria.
- Current episode ≥4 weeks.
- CGI-Severity score ≥4 at Screening and Baseline.
Key exclusion criteria (8 listed)
- 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.
- Concomitant psychotropic medication, including herbal preparations and melatonin.
- Psychotherapy of any type.
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 |
|---|---|---|
| Agomelatine (AGO178C) | Drug | AGO178C 0.5 mg /day |
| Agomelatine (AGO178C) | Drug | AGO178C 1 mg / day |
| Placebo | Drug | Placebo |
Primary outcome
Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale
Time frame: Baseline and 8 weeks
5 secondary outcomes
Effect on subjective sleep, as measured by the score of the Leeds Sleep Evaluation Questionnaire (LSEQ) domain "quality of sleep" at Week 8
Time frame: 8 weeks
Proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the Baseline clinician-rated HAM-D total score at Week 8 endpoint
Time frame: 8 weeks
Proportion of patients who demonstrate clinical improvement at Week 8, where improvement is defined by a score of 1 or 2 on the CGI-I scale
Time frame: 8 weeks
Proportion of patients who achieve remission
Time frame: 8 weeks
Safety and tolerability by adverse events and serious adverse events, and assessment of suicidal ideation and behavior by Columbia Suicide Severity Rating Scale.
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
- https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=6663Link 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
48 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 Agomelatine (AGO178C) in people with Major Depressive Disorder, run by Novartis Pharmaceuticals at 48 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 3 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: finished, as of the sponsor's last update on 23 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 48 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline to endpoint at Week 8 using the total score of the Hamilton Depression Rating Scale (time frame: Baseline and 8 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 23 Dec 2020.