Major Depressive DisorderPhase 3NCT00411099
Efficacy, Safety and Tolerability of Agomelatine in the Treatment of Major Depressive Disorder
A Phase 3 study testing agomelatine in people with Major Depressive Disorder, run by Novartis at 44 sites in 2 countries.
Trial summary
This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label 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
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 508 participants
- Where
- 44 sitesin 2 countries
- Study dates
- Dec 2006to Jan 2008
- 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
- Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
- HAM-D17 total score > or = 22 at Screening and Baseline
- CGI-Severity score > or = 4 at Screening and Baseline
- Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase
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
- Concomitant psychotropic medication, including herbal preparations and melatonin
- Psychotherapy of any type
- Female patients of childbearing potential who are not using effective contraception
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
44 sites in 2 countries.
44 sites in 2 countries
United States42 sites
Novartis Investigative Site
Albuquerque, New Mexico, 87102
Novartis Investigative Site
Atlanta, Georgia, 30308
Novartis Investigative Site
Atlanta, Georgia, 30329
Novartis Investigative Site
Austin, Texas, 78754
Novartis Investigative Site
Beachwood, Ohio, 44122
Novartis Investigative Site
Bennington, Vermont, 05201
Novartis Investigative Site
Bothell, Washington, 98011
Novartis Investigative Site
Bradenton, Florida, 34208
Novartis Investigative Site
Brooklyn, New York, 11235
Novartis Investigative Site
Cerritos, California, 90703
Novartis Investigative Site
City of Saint Peters, Missouri, 63376
Novartis Investigative Site
Cromwell, Connecticut, 06416
Novartis Investigative Site
Dallas, Texas, 75231
Novartis Investigative Site
Dayton, Ohio, 45408
Novartis Investigative Site
El Centro, California, 92243
Novartis Investigative Site
Eugene, Oregon, 97404
Novartis Investigative Site
Farmington Hills, Michigan, 48336
Novartis Investigative Site
Garden Grove, California, 92845
Novartis Investigative Site
Hamden, Connecticut, 06518
Novartis Investigative Site
Houston, Texas, 77007
Novartis Investigative Site
Irvine, California, 92618
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Lafayette, California, 94549
Novartis Investigative Site
Little Rock, Arkansas, 72205
Novartis Investigative Site
Maitland, Florida, 32751
Novartis Investigative Site
Marietta, Georgia, 30060
Novartis Investigative Site
Midlothian, Virginia, 23112
Novartis Investigative Site
Nashville, Tennessee, 37203
Novartis Investigative Site
New York, New York, 10021
Novartis Investigative Site
North Charleston, South Carolina, 29406
Novartis Investigative Site
Overland Park, Kansas, 66212
Novartis Investigative Site
Pittsfield, Massachusetts, 01201
Novartis Investigative Site
Port Charlotte, Florida, 33952
Novartis Investigative Site
Princeton, New Jersey, 08540
Novartis Investigative Site
Rochester Hills, Michigan, 48307
Novartis Investigative Site
Rockville, Maryland, 20852
Novartis Investigative Site
Salisbury, Maryland, 21801
Novartis Investigative Site
Salt Lake City, Utah, 84107
Novartis Investigative Site
San Diego, California, 92126
Novartis Investigative Site
Scottsdale, Arizona, 85251
Novartis Investigative Site
Temecula, California, 92591
Novartis Investigative Site
Tulsa, Oklahoma, 74136
Puerto Rico2 sites
Novartis Investigative Site
Bayamón, 00959
Novartis Investigative Site
Rio Piedras
About this study
Official title: An 8-week, Randomized, Double-blind, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2301E)
This study will assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label phase.
- 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.
To evaluate the change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
Measured: 8 weeks
Secondary outcomes (5)
To evaluate the 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
To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17
Measured: 8 weeks
To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8
Measured: 8 weeks
To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17
Measured: 8 weeks
To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8
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 posted13 Dec 2006 (estimated)
- Study startDec 2006
- Primary completionJan 2008
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 508 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411099
- Sponsor's protocol ID
- CAGO178A2301
- Status last verified
- May 2012
- First submitted
- 11 Dec 2006
- 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, Fixed Dosage, Placebo-controlled, Parallel-group, Multi-center Study of the Efficacy, Safety and Tolerability of Agomelatine 25 mg and 50 mg in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week, Open-label Extension (CAGO178A2301E)
- ClinicalTrials.gov ID
- NCT00411099
- Acronym / sponsor ID
- CAGO178A2301
- Conditions
- Major Depressive Disorder
- Keywords
- agomelatine, major depressive disorder, MDD, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 508 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jan 2008 (actual)
- First posted
- 13 Dec 2006 (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 assess efficacy, safety and tolerability of agomelatine (AGO178) 25 mg and 50 mg in patients with Major Depressive Disorder (MDD). This study includes an 8-week double-blind phase and a 52-week open-label 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 |
|---|---|---|
| 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)
- Diagnosis of Major Depressive Disorder, single or recurrent episode, according to DSM-IV criteria
- HAM-D17 total score > or = 22 at Screening and Baseline
- CGI-Severity score > or = 4 at Screening and Baseline
- Only patients who complete the core protocol are eligible to participate in the Open-Label Extension Phase
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
- 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 | Drug | 1, 2 |
| placebo | Drug | 3 |
Primary outcome
To evaluate the change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17)
Time frame: 8 weeks
5 secondary outcomes
To evaluate the 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
To evaluate the proportion of patients who achieve remission at Week 8, where remission is defined by a total score of < or =7 on the HAM-D17
Time frame: 8 weeks
To evaluate efficacy with respect to the proportion of patients who demonstrate clinical response, where response is defined by a reduction of at least 50% in the baseline HAM-D17 at week 8
Time frame: 8 weeks
To evaluate the change from baseline to week 8 on the subscale scores (Maier, anxiety, retardation and sleep) of the clinician-rated HAM-D17
Time frame: 8 weeks
To evaluate subjective sleep (onset and quality), as measured by the scores on the Leeds Sleep Evaluation Questionnaire (LSEQ) at week 8
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.
- Results for CAGO178A2301 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
44 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 in people with Major Depressive Disorder, run by Novartis at 44 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 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 44 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?
To evaluate the change from Baseline to Week 8 on the total score of the clinician rated 17-Item Hamilton Depression Rating Scale (HAM-D17) (time frame: 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.