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NCT00969709 · ClinicalTrials.gov registry record · Phase 3
Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder
A Phase 3 study of Major Depressive Disorder, sponsored by Forest Laboratories.
- Completed
- Registry status
- Phase 3
- Development phase
- 724
- Enrollment target
- 20
- Study locations
NCT00969709: Completed Phase 3 study of Major Depressive Disorder, sponsored by Forest Laboratories.
NCT00969709 is a Phase 3 study of Major Depressive Disorder that has completed, run by Forest Laboratories. The registered enrollment target is 724 participants, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (94% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00969709, a Phase 3 study of Major Depressive Disorder, has completed, sponsored by Forest Laboratories.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 724 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.
Primary Outcome
The MADRS was used to assess depressive symptomatology during the past week. Patients are rated on 10 items to assess feelings of sadness, lassitude, pessimism, inner tension, suicidality, reduced sleep or appetite, difficulty concentrating, and lack of interest. Each item of the 10 items are scored on a 7-point scale. A score of 0 indicates the absence of symptoms,and a score of 6 indicates symptoms of maximum severity. The total MADRS score for this measure ranges from 0 (absence of symptoms)
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Levomilnacipran ER
Study Locations (20)
Florida
- Forest Investigative Site - Coral Springs
- Forest Investigative Site - Fort Myers
- Forest Investigative Site - Hallandale
- Forest Investigative Site - Jacksonville
- Forest Investigative Site - Orlando
- Forest Investigative Site - West Palm Beach
California
- Forest Investigative Site - Beverly Hills
- Forest Investigative Site - Costa Mesa
- Forest Investigative Site - Escondido
- Forest Investigative Site - Oceanside
- Forest Investigative Site - Sherman Oaks
Arizona
- Forest Investigative Site - Phoenix
- Forest Investigative Site - Scottsdale
Maryland
- Forest Investigative Site - Baltimore
- Forest Investigative Site - Rockville
Colorado
- Forest Investigative Site - Denver
Connecticut
- Forest Investigative Site - Cromwell
Illinois
- Forest Investigative Site - Hoffman Estates
Kansas
- Forest Investigative Site - Wichita
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 724 participants |
| Start Date | 2009-09 |
| Phase | Phase 3 |
What the finished NCT00969709 record still lists
NCT00969709 is an interventional study that assigns participants to a tested intervention. The registered 724 participants enrollment target is mid-sized for trials with a published cap, above the 374-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (94% higher).
The record links to 1 condition, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT00969709 names 20 study sites across 9 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT00969709 about?
NCT00969709 is a clinical study titled "Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder". The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER fixed doses versus placebo in the treatment of outpatients with major depressive disorder.
What is the current status of trial NCT00969709?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 724 participants. The study started on 2009-09.
What conditions does trial NCT00969709 study?
This clinical trial studies the following conditions: Major Depressive Disorder.
What interventions are being tested in trial NCT00969709?
The interventions under investigation include: Placebo (DRUG), Levomilnacipran ER (DRUG).
Who is sponsoring clinical trial NCT00969709?
This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00969709 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Major Depressive Disorder
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 NCT00969709's enrollment target sits among peer trials
724 18th of 282 higher than 265 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder 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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