Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression - Full Text View

Purpose

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	Intervention	Phase
Major Depressive Disorder	Drug: Duloxetine	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: 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

Resource links provided by NLM:

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:


Estimated Enrollment:	120
Study Start Date:	June 2002
Estimated Study Completion Date:	August 2002

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

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: NCT00042575

Locations


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

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):

Wohlreich MM, Mallinckrodt CH, Prakash A, Watkin JG, Carter WP. Duloxetine for the treatment of major depressive disorder: safety and tolerability associated with dose escalation. Depress Anxiety. 2007;24(1):41-52.


ClinicalTrials.gov Identifier:	NCT00042575 History of Changes
Other Study ID Numbers:	6475, F1J-US-HMBY
Study First Received:	July 31, 2002
Last Updated:	July 18, 2006
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:


Sad, blue, lack of energy, depressed, hopelessness, guilt

Additional relevant MeSH terms:


Depressive Disorder, Major Depressive Disorder Mental Disorders Mood Disorders 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 March 03, 2015