Major Depressive DisorderPhase 3NCT00467402
Efficacy, Safety and Tolerability of Agomelatine in the Prevention of Relapse of Major Depressive Disorder
A Phase 3 study testing agomelatine in people with Major Depressive Disorder, run by Novartis at 78 sites in United States.
Trial summary
This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 644 participants
- Where
- 78 sitesUnited States
- Study dates
- Apr 2007to Sep 2009
- 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
- Male and female adults, 18 through 70 years of age, inclusive
- Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
- A history of at least two previous episodes of Major Depression plus the current episode
- Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline
Who cannot join
- History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
- Any current Axis I disorder other than major depressive disorder which is the focus of treatment
- Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
- Use of any psychoactive medication after the screening visit
- Patients who have been previously treated with agomelatine
- Female patients of childbearing potential who are not using effective contraception
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
78 sites in 1 country.
78 sites in 1 country
United States78 sites
Novartis Investigative Site
Albuquerque, New Mexico, 87102
Novartis Investigative Site
Allentown, Pennsylvania, 18104
Novartis Investigative Site
Atlanta, Georgia, 30328
Novartis Investigative Site
Austin, Texas, 78754
Novartis Investigative Site
Austin, Texas, 78756
Novartis Investigative Site
Beverly Hills, California, 90210
Novartis Investigative Site
Birmingham, Alabama, 35226
Novartis Investigative Site
Boston, Massachusetts, 02135
Novartis Investigative Site
Bradenton, Florida, 34208
Novartis Investigative Site
Braintree, Massachusetts, 02184
Novartis Investigative Site
Buffalo, New York, 14215
Novartis Investigative Site
Chapel Hill, North Carolina, 27599
Novartis Investigative Site
Charleston, South Carolina, 29412
Novartis Investigative Site
Chicago, Illinois, 60611
Novartis Investigative Site
Chicago, Illinois, 60640
Novartis Investigative Site
Cleveland, Ohio, 44195
Novartis Investigative Site
Columbus, Ohio, 43210
Novartis Investigative Site
Coral Springs, Florida, 33065
Novartis Investigative Site
Costa Mesa, California, 92626
Novartis Investigative Site
DeSoto, Texas, 75115
Novartis Investigative Site
Edmonds, Washington, 98026
Novartis Investigative Site
Encino, California, 91316
Novartis Investigative Site
Farmington Hills, Michigan, 48336
Novartis Investigative Site
Fort Myers, Florida, 33912
Novartis Investigative Site
Gainesville, Florida, 32607
Novartis Investigative Site
Glendale, California, 91206
Novartis Investigative Site
Houston, Texas, 77007
Novartis Investigative Site
Houston, Texas, 77030
Novartis Investigative Site
Houston, Texas, 77042
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Kansas City, Missouri, 64111
Novartis Investigative Site
Kansas City, Missouri, 66160
Novartis Investigative Site
Lake Jackson, Texas, 77566
Novartis Investigative Site
Lansdale, Pennsylvania, 19446
Novartis Investigative Site
Libertyville, Illinois, 60048
Novartis Investigative Site
Los Angeles, California, 90024
Novartis Investigative Site
Memphis, Tennessee, 38119
Novartis Investigative Site
Milwaukee, Wisconsin, 53226
Novartis Investigative Site
Minneapolis, Minnesota, 55454
Novartis Investigative Site
Nashville, Tennessee, 37212
Novartis Investigative Site
New Orleans, Louisiana, 70114
Novartis Investigative Site
New York, New York, 10021
Novartis Investigative Site
New York, New York, 10029
Novartis Investigative Site
Newark, New Jersey, 07103
Novartis Investigative Site
Newport Beach, California, 92660
Novartis Investigative Site
Oceanside, California, 92056
Novartis Investigative Site
Omaha, Nebraska, 68198
Novartis Investigative Site
Overland Park, Kansas, 66211
Novartis Investigative Site
Peoria, Arizona, 85381
Novartis Investigative Site
Philadelphia, Pennsylvania, 19139
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15213
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15238
Novartis Investigative Site
Portland, Oregon, 97210
Novartis Investigative Site
Portland, Oregon, 97239
Novartis Investigative Site
Raleigh, North Carolina, 27609
Novartis Investigative Site
Rhododendron, Oregon, 97049
Novartis Investigative Site
Richmond, Virginia, 23230
Novartis Investigative Site
Rockville, Maryland, 20852
Novartis Investigative Site
Sacramento, California, 95817
Novartis Investigative Site
Seattle, Washington, 98104
Novartis Investigative Site
Sherman Oaks, California, 91403
Novartis Investigative Site
St Louis, Missouri, 63033
Novartis Investigative Site
St Louis, Missouri, 63044
Novartis Investigative Site
St Louis, Missouri, 63118
Novartis Investigative Site
St. Petersburg, Florida, 33702
Novartis Investigative Site
Temecula, California, 92591
Novartis Investigative Site
The Bronx, New York, 10467
Novartis Investigative Site
Toledo, Ohio, 43623
Novartis Investigative Site
Topeka, Kansas, 66606
Novartis Investigative Site
Towson, Maryland, 21204
Novartis Investigative Site
Towson, Maryland, 85724
Novartis Investigative Site
Tucson, Arizona, 85724
Novartis Investigative Site
Venice, Florida, 34285
Novartis Investigative Site
Virginia Beach, Virginia, 23230
Novartis Investigative Site
West Allis, Wisconsin, 53227
Novartis Investigative Site
West Palm Beach, Florida, 33407
Novartis Investigative Site
Wheat Ridge, Colorado, 80033
Novartis Investigative Site
Worcester, Massachusetts, 01605
About this study
Official title: A 52-week, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-label Treatment of 16-24 Weeks
This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.
- Conditions
- Major Depressive Disorder
- Being tested
- agomelatine, 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.
agomelatineDrug
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: agomelatine |
| 2 | Experimental | Not described Receives: Drug: agomelatine |
| 3 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to relapse, where relapse is defined by the occurrence of any one of the following:
Measured: Primary efficacy variable is measured from randomization to relapse
Hamilton Depression Rating Scale total score ≥16 at two consecutive visits;
Measured: Primary efficacy variable is measured from randomization to relapse
hospitalization due to depression;
Measured: Primary efficacy variable is measured from randomization to relapse
suicide attempt or suicide;
Measured: Primary efficacy variable is measured from randomization to relapse
discontinuation due to lack of efficacy according to Investigator judgment.
Measured: Primary efficacy variable is measured from randomization to relapse
Secondary outcomes (4)
Proportion of patients who demonstrate clinical improvement at the end of the double-blind continuation phase, where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale.
Measured: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Proportion of patients experiencing relapse during the double-blind continuation phase.
Measured: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Proportion of patients who achieve remission at the end of the double-blind continuation phase, where remission is defined by a total score of ≤7 on the HAM-D.
Measured: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores.
Measured: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2007 (estimated)
- Study startApr 2007
- Primary completionSep 2009
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 644 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00467402
- Sponsor's protocol ID
- CAGO178A2304
- Status last verified
- May 2012
- First submitted
- 27 Apr 2007
- 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
- A 52-week, Randomized, Double-blind, Placebo-controlled, Multi-center, Parallel-group Study of the Long-term Efficacy, Tolerability and Safety of Agomelatine 25 and 50 mg in the Prevention of Relapse of Major Depressive Disorder (MDD) Following Open-label Treatment of 16-24 Weeks
- ClinicalTrials.gov ID
- NCT00467402
- Acronym / sponsor ID
- CAGO178A2304
- Conditions
- Major Depressive Disorder
- Keywords
- agomelatine, Major Depressive Disorder, MDD, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 644 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Apr 2007
- Primary completion
- Sep 2009 (actual)
- First posted
- 30 Apr 2007 (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.
This study will demonstrate the efficacy of agomelatine (AGO178) 25 mg and 50 mg in the prevention of relapse in patients with Major Depressive Disorder (MDD). Eligible patients will undergo open-label treatment for 20 to 26 weeks, depending on response to treatment. Patients demonstrating stable response at the end of the open-label treatment phase will be assigned to receive agomelatine or placebo for 52 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: agomelatine |
| 2 | Experimental | Drug: agomelatine |
| 3 | 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 (4 listed)
- Male and female adults, 18 through 70 years of age, inclusive
- Diagnosis of Major Depressive Disorder, recurrent episode, according to Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria
- A history of at least two previous episodes of Major Depression plus the current episode
- Hamilton Depression Rating Scale (HAM-D17) total score ≥ 22 at Screening and Baseline
Key exclusion criteria (7 listed)
- History of bipolar disorder (I or II), schizophrenia, schizoaffective disorder, eating disorder, or obsessive compulsive disorder
- Any current Axis I disorder other than major depressive disorder which is the focus of treatment
- Substance or alcohol abuse in the last 30 days, dependence in the last 6 months
- Use of any psychoactive medication after the screening visit
- Patients who have been previously treated with agomelatine
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 | Drug | 1, 2 |
| placebo | Drug | 3 |
Primary outcome
Time to relapse, where relapse is defined by the occurrence of any one of the following:
Time frame: Primary efficacy variable is measured from randomization to relapse
Hamilton Depression Rating Scale total score ≥16 at two consecutive visits;
Time frame: Primary efficacy variable is measured from randomization to relapse
hospitalization due to depression;
Time frame: Primary efficacy variable is measured from randomization to relapse
suicide attempt or suicide;
Time frame: Primary efficacy variable is measured from randomization to relapse
discontinuation due to lack of efficacy according to Investigator judgment.
Time frame: Primary efficacy variable is measured from randomization to relapse
4 secondary outcomes
Proportion of patients who demonstrate clinical improvement at the end of the double-blind continuation phase, where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale.
Time frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Proportion of patients experiencing relapse during the double-blind continuation phase.
Time frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Proportion of patients who achieve remission at the end of the double-blind continuation phase, where remission is defined by a total score of ≤7 on the HAM-D.
Time frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
Change from randomization to the end of the double-blind continuation phase, on the Hospital Anxiety and Depression (HAD) total score and subscale scores.
Time frame: Secondary efficacy variables will be measured from randomization to the end of the Double-Blind continuation Phase
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.
- Results for CAGO178A2304 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.
The record lists no contact. Use the official record to reach the sponsor.
78 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing agomelatine in people with Major Depressive Disorder, run by Novartis at 78 sites in United States.
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 4 inclusion and 7 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 78 sites in United States. 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?
Time to relapse, where relapse is defined by the occurrence of any one of the following: (time frame: Primary efficacy variable is measured from randomization to relapse). The study lists 5 primary outcomes in all. 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.