Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00036309 |
Recruitment Status :
Completed
First Posted : May 9, 2002
Last Update Posted : July 19, 2006
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Depressive Disorder | Drug: Duloxetine Hydrochloride | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Official Title: | Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder |
Study Start Date : | May 2002 |
Study Completion Date : | July 2003 |


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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00036309
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 |
ClinicalTrials.gov Identifier: | NCT00036309 |
Other Study ID Numbers: |
4445 F1J-MC-HMBC |
First Posted: | May 9, 2002 Key Record Dates |
Last Update Posted: | July 19, 2006 |
Last Verified: | July 2006 |
Major Depressive Disorder Diagnostic and Statistical Manual of Mental Disorders Fourth Edition-defined major depressive disorder without psychotic features |
Disease Depressive Disorder Depression Depressive Disorder, Major Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents |