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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 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.

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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).

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

FieldValue
Enrollment Target 734 participants
Start Date 2010-03
Est. Completion 2011-10
Phase Phase 3

Sponsor

Forest Laboratories

145 total trials

What the Registry Record Tells You About NCT01085812

The ClinicalTrials.gov registry entry for NCT01085812 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 734 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 785-participant average among 679 other Depression trials with a reported enrollment target. The listed sponsor is Forest Laboratories, which has 145 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.