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COMPLETED Phase 3

Relapse-Prevention Study With Levomilnacipran ER (F2695 SR) in Patients With Major Depressive Disorder

NCT01085812 · View on ClinicalTrials.gov ↗

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

32 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01085812

The ClinicalTrials.gov registry entry for NCT01085812 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 734 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Forest Laboratories, which has 32 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01085812 reports 20 study locations spanning 8 distinct geographic areas — top geographies include California, Florida, Illinois. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01085812?

The interventions under investigation include: Placebo (DRUG), Levomilnacipran ER (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01085812?

This trial is sponsored by Forest Laboratories, which has 32 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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