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NCT01085812 · ClinicalTrials.gov registry record · Phase 3
Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder
A Phase 3 study of Depression and Major Depressive Disorder, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 734
- Enrollment target
- 20
- Study locations
NCT01085812: Completed Phase 3 study of Depression and Major Depressive Disorder, sponsored by Forest Laboratories.
NCT01085812 is a Phase 3 study of Depression and Major Depressive Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 734 participants, roughly in line with the 785-participant average among 679 other Depression trials with a reported enrollment target. The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01085812, a Phase 3 study of Depression and Major Depressive Disorder, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 734 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).
Primary Outcome
Number of days until patients meet relapse criteria. Relapse was defined as 1 or more of the following: 1. MADRS total score of at least 22 at 2 consecutive visits 2. Increase of 2 or more points in CGI-I score compared with the CGI-I score at Visit 9 at 2 consecutive visits 3. Premature discontinuation due to insufficient therapeutic response 4. MADRS item 10 score of at least 4
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Levomilnacipran ER
Study Locations (20)
California
- Forest Investigative Site #023 - Beverly Hills
- Forest Investigative Site #017 - Encino
- Forest Investigative Site #021 - Garden Grove
- Forest Investigative Site #025 - Newport Beach
- Forest Investigative Site #030 - Orange
- Forest Investigative Site #002 - San Diego
- Forest Investigative Site #003 - Sherman Oaks
Florida
- Forest Research Institute #001 - Bonita Springs
- Forest Investigative Site #015 - Fort Myers
- Forest Investigative Site #029 - Maitland
- Forest Investigative Site #005 - North Miami
- Forest Investigative Site #016 - Orlando
- Forest Investigative Site #004 - South Miami
Illinois
- Forest Investigative Site #022 - Chicago
- Forest Investigative Site #006 - Chicago
Georgia
- Forest Investigative Site #014 - Atlanta
Kansas
- Forest Investigative Site #009 - Prairie Village
Maryland
- Forest Investigative Site #013 - Baltimore
Massachusetts
- Forest Investigative Site #010 - Boston
Missouri
- Forest Investigative Site #012 - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 734 participants |
| Start Date | 2010-03 |
| Est. Completion | 2011-10 |
| Phase | Phase 3 |
What the finished NCT01085812 record still lists
NCT01085812 is an interventional study that assigns participants to a tested intervention. The registered 734 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 785-participant average among 679 other Depression trials with a reported enrollment target.
The record links to 2 conditions, with Depression appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01085812 names 20 study sites across 8 states, led by California, Florida, Illinois.
Frequently Asked Questions
What is clinical trial NCT01085812 about?
NCT01085812 is a clinical study titled "Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder". The purpose of this study is to evaluate the safety and efficacy of Levomilnacipran ER relative to placebo in the prevention of depression relapse in patients with major depressive disorder (MDD).
What is the current status of trial NCT01085812?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 734 participants. The study started on 2010-03. Estimated completion is 2011-10.
What conditions does trial NCT01085812 study?
This clinical trial studies the following conditions: Depression, Major Depressive Disorder.
What interventions are being tested in trial NCT01085812?
The interventions under investigation include: Placebo (DRUG), Levomilnacipran ER (DRUG).
Who is sponsoring clinical trial NCT01085812?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01085812 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Depression
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01085812's enrollment target sits among peer trials
734 55th of 679 higher than 625 of 679 other Depression trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Depression trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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