Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression
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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: NCT00042575 |
Recruitment Status :
Completed
First Posted : August 5, 2002
Last Update Posted : July 19, 2006
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The Purposes of this Study are to determine:
The safety of duloxetine and any side effects that might be associated with it.
Whether duloxetine can help patients with major depression.
It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.
Duloxetine might not have any good effects for you.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Major Depressive Disorder | Drug: Duloxetine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 120 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression |
Study Start Date : | June 2002 |
Study Completion Date : | August 2002 |


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, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- You must be at least 18 years old.
- You must be diagnosed with major depressive disorder
- You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 8 weeks.
Exclusion Criteria:
- You are a woman and are pregnant or breastfeeding.
- You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder.
- You have a history of alcohol or drug dependence or abuse within the past 6 months.
- You are allergic to the study drug or you have experienced allergic reactions when taking several medications at once.
- You have a serious medical illness.

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): NCT00042575
United States, Connecticut | |
Trumbull, Connecticut, United States | |
United States, Indiana | |
Lafayette, Indiana, United States | |
United States, Maryland | |
Gaithersburg, Maryland, United States | |
United States, Massachusetts | |
Belmont, Massachusetts, United States | |
United States, Nebraska | |
Omaha, Nebraska, United States | |
United States, New Mexico | |
Albuquerque, New Mexico, United States | |
United States, New York | |
Staten Island, New York, United States | |
United States, Utah | |
Salt Lake City, Utah, United States | |
United States, Washington | |
Bellevue, Washington, United States |
ClinicalTrials.gov Identifier: | NCT00042575 |
Other Study ID Numbers: |
6475 F1J-US-HMBY |
First Posted: | August 5, 2002 Key Record Dates |
Last Update Posted: | July 19, 2006 |
Last Verified: | July 2006 |
Sad, blue, lack of energy, depressed, hopelessness, guilt |
Depressive Disorder Depressive Disorder, Major Mood Disorders Mental Disorders 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 |