Major Depressive DisorderPhase 3NCT00463242
A Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine (25 or 50 mg) in the Treatment of Major Depressive Disorder (MDD)
A Phase 3 study testing Agomelatine and paroxetine in people with Major Depressive Disorder, run by Novartis at 47 sites in 2 countries.
Trial summary
This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. 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 and paroxetine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 501 participants
- Where
- 47 sitesin 2 countries
- Study dates
- Mar 2007to Jun 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
- Male and female adults, 18 through 70 years of age, inclusive
- Diagnosis of Major Depressive Disorder according to DSM-IV criteria
- HAM-D17 total score > or = 22 at Screening and Baseline
Who cannot join
- History of non-response to paroxetine
- Patients who have been previously treated with agomelatine
- 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
- Female patients of childbearing potential who are not using effective contraception
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
47 sites in 2 countries.
47 sites in 2 countries
United States46 sites
Novartis Investigative Site
Augusta, Georgia, 30912
Novartis Investigative Site
Austin, Texas, 78756
Novartis Investigative Site
Baltimore, Maryland, 21205
Novartis Investigative Site
Baltimore, Maryland, 21208
Novartis Investigative Site
Bellevue, Washington, 98004
Novartis Investigative Site
Boca Raton, Florida, 33431
Novartis Investigative Site
Canton, Ohio, 44718
Novartis Investigative Site
Charlotte, North Carolina, 28211
Novartis Investigative Site
Colorado Springs, Colorado, 80909
Novartis Investigative Site
Corvallis, Oregon, 97330
Novartis Investigative Site
Dallas, Texas, 75230
Novartis Investigative Site
Durham, North Carolina, 27710
Novartis Investigative Site
Erie, Pennsylvania, 16506
Novartis Investigative Site
Fall River, Massachusetts, 02721
Novartis Investigative Site
Fort Myers, Florida, 33912
Novartis Investigative Site
Friendswood, Texas, 77546
Novartis Investigative Site
Herndon, Virginia, 20170
Novartis Investigative Site
Honolulu, Hawaii, 96813
Novartis Investigative Site
Houston, Texas, 77008
Novartis Investigative Site
Jacksonville, Florida, 32216
Novartis Investigative Site
Jacksonville, Florida, 32256
Novartis Investigative Site
Joliet, Illinois, 60435
Novartis Investigative Site
Lincoln, Nebraska, 68510
Novartis Investigative Site
Media, Pennsylvania, 19063
Novartis Investigative Site
Miami, Florida, 33143
Novartis Investigative Site
National City, California, 91950
Novartis Investigative Site
New York, New York, 10024
Novartis Investigative Site
Okemos, Michigan, 48864
Novartis Investigative Site
Orange, California, 92868
Novartis Investigative Site
Orlando, Florida, 32806
Novartis Investigative Site
Overland Park, Kansas, 66212
Novartis Investigative Site
Pasadena, California, 91105
Novartis Investigative Site
Philadelphia, Pennsylvania, 19104
Novartis Investigative Site
Phoenix, Arizona, 85016
Novartis Investigative Site
Pico Rivera, California, 90660
Novartis Investigative Site
Redlands, California, 92374
Novartis Investigative Site
Richmond, Virginia, 23230
Novartis Investigative Site
Rockville, Maryland, 20852
Novartis Investigative Site
Saint Charles, Missouri, 63301
Novartis Investigative Site
San Diego, California, 92120
Novartis Investigative Site
San Diego, California, 92126
Novartis Investigative Site
St Louis, Missouri, 63141
Novartis Investigative Site
Torrance, California, 90502
Novartis Investigative Site
Waukesha, Wisconsin, 53188
Novartis Investigative Site
Willingboro, New Jersey, 08046
Novartis Investigative Site
Winter Park, Florida, 32789
About this study
Official title: An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg
This study will evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.
- Conditions
- Major Depressive Disorder
- Being tested
- Agomelatine, paroxetine, 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
Either 25 mg or 50 mg agomelatine orally once daily
paroxetineDrug
Also called Paxil
placeboDrug
| Study group | Role | What they receive |
|---|---|---|
| Agomelatine | Experimental | Dosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began. Receives: Drug: Agomelatine |
| 2 | Active comparator | Not described Receives: Drug: paroxetine |
| 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.
Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale
Measured: 8 weeks
Secondary outcomes (4)
To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX).
Measured: 8 weeks
Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8.
Measured: 8 weeks
Proportion of patients with MDD who achieve remission,
Measured: 8 weeks
Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD).
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 posted20 Apr 2007 (estimated)
- Study startMar 2007
- Primary completionJun 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
- 501 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
- NCT00463242
- Sponsor's protocol ID
- CAGO178A2303
- Status last verified
- May 2012
- First submitted
- 19 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
- An 8-week, Multicenter, Randomized, Double-blind, Placebo- and Paroxetine-controlled Study of the Efficacy, Safety and Tolerability of Agomelatine 25 or 50 mg Given Once Daily in the Treatment of Major Depressive Disorder (MDD) Followed by a 52-week Open-label Treatment With Agomelatine 25 or 50 mg
- ClinicalTrials.gov ID
- NCT00463242
- Acronym / sponsor ID
- CAGO178A2303
- Conditions
- Major Depressive Disorder
- Keywords
- agomelatine, Major Depressive Disorder, MDD, depression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 501 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Mar 2007
- Primary completion
- Jun 2008 (actual)
- First posted
- 20 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 evaluate the efficacy, safety and tolerability of agomelatine 25 mg or 50 mg per day and will compare agomelatine and paroxetine tolerability. Eligible patients will receive double-blind study medication for 8 weeks. One week after completion of the double-blind treatment phase there will be a single follow-up visit.
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 |
|---|---|---|
| Agomelatine | Experimental | Drug: AgomelatineDosing for each subject in this extension study began with the same dose (25 mg or 50 mg of agomelatine orally once daily) the subject was receiving at the end of Week 8, the week before this study began. |
| 2 | Active comparator | Drug: paroxetine |
| 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 (3 listed)
- Male and female adults, 18 through 70 years of age, inclusive
- Diagnosis of Major Depressive Disorder according to DSM-IV criteria
- HAM-D17 total score > or = 22 at Screening and Baseline
Key exclusion criteria (8 listed)
- History of non-response to paroxetine
- Patients who have been previously treated with agomelatine
- 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
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 |
|---|---|---|
| AgomelatineEither 25 mg or 50 mg agomelatine orally once daily | Drug | Agomelatine |
| paroxetineAlso: Paxil | Drug | 2 |
| placebo | Drug | 3 |
Primary outcome
Change from Baseline to Week 8 on the total score Hamilton Depression Rating Scale
Time frame: 8 weeks
4 secondary outcomes
To demonstrate less sexual dysfunction in patients with MDD receiving agomelatine compared to paroxetine, as measured by the change from baseline to Week 8 on the total score of the Arizona Sexual Experience Scale (ASEX).
Time frame: 8 weeks
Proportion of patients who demonstrate clinical improvement where improvement is defined by a score of 1 or 2 on the Clinical Global Impression Improvement (CGI-I) scale at Week 8.
Time frame: 8 weeks
Proportion of patients with MDD who achieve remission,
Time frame: 8 weeks
Change from baseline to Week 8 on the total score and Anxiety subscale of the Hospital Anxiety and Depression Scale (HAD).
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 CAGO178A2303 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
47 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 and paroxetine in people with Major Depressive Disorder, run by Novartis at 47 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 47 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 Week 8 on the total score Hamilton Depression Rating Scale (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.