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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00036309
First received: May 8, 2002
Last updated: July 18, 2006
Last verified: July 2006
  Purpose

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.


Condition Intervention Phase
Depressive Disorder
Drug: Duloxetine Hydrochloride
Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Study Start Date: May 2002
Estimated Study Completion Date: July 2003
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00036309

Locations
United States, North Carolina
For information on a site near you, call our call center at 1-877-CTLILLY (1-877-285-4559)
Durham, North Carolina, United States
Sponsors and Collaborators
Eli Lilly and Company
  More Information

No publications provided by Eli Lilly and Company

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00036309     History of Changes
Other Study ID Numbers: 4445, F1J-MC-HMBC
Study First Received: May 8, 2002
Last Updated: July 18, 2006
Health Authority: United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:
Major Depressive Disorder
Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Disease
Behavioral Symptoms
Mental Disorders
Mood Disorders
Pathologic Processes
Duloxetine
Adrenergic Agents
Adrenergic Uptake Inhibitors
Analgesics
Antidepressive Agents
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Sensory System Agents
Serotonin Agents
Serotonin Uptake Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014