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COMPLETED Phase 3

Safety and Efficacy of Levomilnacipran ER (F2695 SR) in Major Depressive Disorder

NCT00969709 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 724 participants
Start Date 2009-09
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 NCT00969709

The ClinicalTrials.gov registry entry for NCT00969709 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 724 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 1 condition, with Major Depressive Disorder 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: NCT00969709 reports 20 study locations spanning 9 distinct geographic areas — top geographies include Florida, California, Arizona. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT00969709?

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 NCT00969709?

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 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.

Related

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