Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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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:
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| 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
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
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:
|
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 |
ClinicalTrials.gov processed this record on September 27, 2016