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OpenTrials
Completed

NCT Number: NCT00036309

Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

The purpose of this study is to determine if duloxetine is effective when compared to placebo in preventing recurrence of major depressive disorder in patients who have responded to open-label duloxetine treatment.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)

Durham, North Carolina, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed the informed consent
  • Meet criteria for major depressive disorder without psychotic features.
  • Have a level of understanding sufficient to provide informed consent and to communicate with the investigator and site personnel.
  • Have had at least one other major depressive episode prior to the one being experienced at study entry.
  • You are reliable and agree to keep all appointments for clinic visits, tests and procedures required by the protocol.

Exclusion criteria

  • You have had treatment with a drug within the last 30 days that has not received regulatory approval at the time of study entry.
  • Any women who are pregnant or breast feeding.
  • If you have any serious medical illnesses other than major depressive disorder.
  • If you have previously participated in a clinical trial for duloxetine.
  • Any previous or current diagnosis of bipolar, schizophrenia, or other psychotic disorders.

Treatment and study plan

duloxetine hydrochloride

Drug

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Important dates

Study start
2002
Study completion
2003
First posted
May 9, 2002
Registry last updated
Jul 19, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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