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NCT00969150 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Forest Laboratories.

Completed
Registry status
Phase 3
Development phase
362
Enrollment target

NCT00969150: Completed Phase 3 study, sponsored by Forest Laboratories.

NCT00969150 is a Phase 3 study that has completed, run by Forest Laboratories. The registered enrollment target is 362 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00969150, a Phase 3 study, has completed, sponsored by Forest Laboratories.

COMPLETED
Registry status
Phase 3
Development phase
362 participants
Enrollment target

Study Summary

The purpose of this study is to evaluate the efficacy, safety, and tolerability of Levomilnacipran ER versus placebo in the treatment of outpatients with major depressive disorder.

Primary Outcome

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) to

Interventions

  • DRUG Placebo
  • DRUG Levomilnacipran ER

Trial Details

FieldValue
Enrollment Target 362 participants
Start Date 2009-09
Phase Phase 3
Forest Laboratories

145 total trials

What the finished NCT00969150 record still lists

NCT00969150 is an interventional study that assigns participants to a tested intervention. The registered 362 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (53% lower).

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT00969150 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00969150 about?

NCT00969150 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 versus placebo in the treatment of outpatients with major depressive disorder.

What is the current status of trial NCT00969150?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 362 participants. The study started on 2009-09.

What interventions are being tested in trial NCT00969150?

The interventions under investigation include: Placebo (DRUG), Levomilnacipran ER (DRUG).

Who is sponsoring clinical trial NCT00969150?

This trial is sponsored by Forest Laboratories, which has 145 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00969150's enrollment target sits among peer trials

362 1007th of 2000 higher than 993 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00969150, the US trial registry maintained by the National Library of Medicine. NCT00969150 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.