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)
Public ClinicalTrials.gov record NCT00463242. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00463242
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 501 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 2007 (Type not available)
- Primary completion
- Jun 2008 (Actual)
- Completion
- Not listed
- Last update posted
- Dec 23, 2020
Started 2007
United States locations
- U.S. sites
- 46
- U.S. states
- 23
- U.S. cities
- 43
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Phoenix | Arizona | 85016 | — |
| Novartis Investigative Site | National City | California | 91950 | — |
| Novartis Investigative Site | Orange | California | 92868 | — |
| Novartis Investigative Site | Pasadena | California | 91105 | — |
| Novartis Investigative Site | Pico Rivera | California | 90660 | — |
| Novartis Investigative Site | Redlands | California | 92374 | — |
| Novartis Investigative Site | San Diego | California | 92120 | — |
| Novartis Investigative Site | San Diego | California | 92126 | — |
| Novartis Investigative Site | Torrance | California | 90502 | — |
| Novartis Investigative Site | Colorado Springs | Colorado | 80909 | — |
| Novartis Investigative Site | Boca Raton | Florida | 33431 | — |
| Novartis Investigative Site | Fort Myers | Florida | 33912 | — |
| Novartis Investigative Site | Jacksonville | Florida | 32216 | — |
| Novartis Investigative Site | Jacksonville | Florida | 32256 | — |
| Novartis Investigative Site | Miami | Florida | 33143 | — |
| Novartis Investigative Site | Orlando | Florida | 32806 | — |
| Novartis Investigative Site | Winter Park | Florida | 32789 | — |
| Novartis Investigative Site | Augusta | Georgia | 30912 | — |
| Novartis Investigative Site | Honolulu | Hawaii | 96813 | — |
| Novartis Investigative Site | Joliet | Illinois | 60435 | — |
| Novartis Investigative Site | Overland Park | Kansas | 66212 | — |
| Novartis Investigative Site | Baltimore | Maryland | 21205 | — |
| Novartis Investigative Site | Baltimore | Maryland | 21208 | — |
| Novartis Investigative Site | Rockville | Maryland | 20852 | — |
| Novartis Investigative Site | Fall River | Massachusetts | 02721 | — |
| Novartis Investigative Site | Okemos | Michigan | 48864 | — |
| Novartis Investigative Site | Saint Charles | Missouri | 63301 | — |
| Novartis Investigative Site | St Louis | Missouri | 63141 | — |
| Novartis Investigative Site | Lincoln | Nebraska | 68510 | — |
| Novartis Investigative Site | Willingboro | New Jersey | 08046 | — |
| Novartis Investigative Site | New York | New York | 10024 | — |
| Novartis Investigative Site | Charlotte | North Carolina | 28211 | — |
| Novartis Investigative Site | Durham | North Carolina | 27710 | — |
| Novartis Investigative Site | Canton | Ohio | 44718 | — |
| Novartis Investigative Site | Corvallis | Oregon | 97330 | — |
| Novartis Investigative Site | Erie | Pennsylvania | 16506 | — |
| Novartis Investigative Site | Media | Pennsylvania | 19063 | — |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19104 | — |
| Novartis Investigative Site | Austin | Texas | 78756 | — |
| Novartis Investigative Site | Dallas | Texas | 75230 | — |
| Novartis Investigative Site | Friendswood | Texas | 77546 | — |
| Novartis Investigative Site | Houston | Texas | 77008 | — |
| Novartis Investigative Site | Herndon | Virginia | 20170 | — |
| Novartis Investigative Site | Richmond | Virginia | 23230 | — |
| Novartis Investigative Site | Bellevue | Washington | 98004 | — |
| Novartis Investigative Site | Waukesha | Wisconsin | 53188 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00463242, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 23, 2020 · Synced Oct 22, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00463242 live on ClinicalTrials.gov.