A Randomised, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Orvepitant in Subjects With Major Depressive Disorder
Public ClinicalTrials.gov record NCT00880048. 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.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a 6-week, randomised, multicenter, double-blind, placebo controlled, fixed dose parallel group study to assess the efficacy and safety of orvepitant (30 and 60 mg/day) versus placebo in subjects with a diagnosis of a Major Depressive Disorder, whose symptoms are considered moderate or severe. Following an initial screening visit, subjects fulfilling the study inclusion and exclusion criteria will enter a pre-treatment screening phase to permit evaluation of the laboratory and ECG assessments and to confirm eligibility for inclusion into the study. This screening phase will be a minimum of 7 days, but no longer than 21 days. At the completion of the screening period, eligible subjects will be randomised at the baseline visit to receive either orvepitant 30mg/day, orvepitant 60mg/day or placebo (equal chance of receiving any of the three possible treatments, i.e., a 1:1:1 ratio) for a six-week double-blind treatment phase. Those subjects randomised to receive placebo will receive study medication identical in appearance to that received by subjects assigned to receive orvepitant 30 or 60mg/day. Efficacy will be assessed via standard depression symptom and severity rating scales or questionaires. The Hamilton Depression Rating Scale (HAM-D) will be used as the primary measure. Secondary efficacy endpoints include the Quick Inventory of Depressive Symptomatology (QIDS-SR) and the Clinical Global Impression- Global Improvement and Severity of Illness Scale (CGI-I and CGI-S, respectively). Safety will be assessed by monitoring for adverse events (side effects) and through periodic laboratory evaluations (blood tests), vital signs assessments (e.g., blood pressure, heart rate, temperature) and heart function measurements (electrocardiograms, or ECGs).
Study identification
- NCT ID
- NCT00880048
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 343 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 64 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 10, 2009
- Primary completion
- Jun 20, 2010
- Completion
- Jun 20, 2010
- Last update posted
- Oct 12, 2017
2009 – 2010
United States locations
- U.S. sites
- 27
- U.S. states
- 19
- U.S. cities
- 26
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85020 | — |
| GSK Investigational Site | Little Rock | Arkansas | 72223 | — |
| GSK Investigational Site | Orange | California | 92868 | — |
| GSK Investigational Site | Denver | Colorado | 80239 | — |
| GSK Investigational Site | Norwich | Connecticut | 06360 | — |
| GSK Investigational Site | Jacksonville | Florida | 32216 | — |
| GSK Investigational Site | Orlando | Florida | 32806 | — |
| GSK Investigational Site | Winter Park | Florida | 32789 | — |
| GSK Investigational Site | Springfield | Illinois | 62711 | — |
| GSK Investigational Site | Rockville | Maryland | 20852 | — |
| GSK Investigational Site | Weymouth | Massachusetts | 02190 | — |
| GSK Investigational Site | Saint Charles | Missouri | 63301 | — |
| GSK Investigational Site | Willingboro | New Jersey | 08046 | — |
| GSK Investigational Site | Brooklyn | New York | 11235 | — |
| GSK Investigational Site | Dayton | Ohio | 45408 | — |
| GSK Investigational Site | Garfield Heights | Ohio | 44125 | — |
| GSK Investigational Site | Portland | Oregon | 97210 | — |
| GSK Investigational Site | Salem | Oregon | 97301 | — |
| GSK Investigational Site | Emmaus | Pennsylvania | 18049 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19131 | — |
| GSK Investigational Site | Philadelphia | Pennsylvania | 19139 | — |
| GSK Investigational Site | Columbia | South Carolina | 29201 | — |
| GSK Investigational Site | Austin | Texas | 78756 | — |
| GSK Investigational Site | Dallas | Texas | 75231 | — |
| GSK Investigational Site | San Antonio | Texas | 78229-3815 | — |
| GSK Investigational Site | Charlottesville | Virginia | 22903 | — |
| GSK Investigational Site | Milwaukee | Wisconsin | 53226 | — |
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 5 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00880048, 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 Oct 12, 2017 · Synced Sep 3, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00880048 live on ClinicalTrials.gov.