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

This study has been completed.
Sponsor:
Information provided by:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT00042575
First received: July 31, 2002
Last updated: July 18, 2006
Last verified: July 2006
History of Changes
  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:

MedlinePlus related topics: Depression
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
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):

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:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Duloxetine
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
 Pharmacologic Actions
Serotonin Agents
Physiological Effects of Drugs
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013