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

Protocol F1J-US-HMBY Dose Escalation, Double-Blind Treatment With Duloxetine Hydrochloride Once Daily Dosing for Evaluation of Safety in Major Depression

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Drug: Duloxetine

• Study Type: Interventional
• Enrollment: 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Trumbull, Connecticut, United States
  • Indiana
    • Lafayette, Indiana, United States
  • Maryland
    • Gaithersburg, Maryland, United States
  • Massachusetts
    • Belmont, Massachusetts, United States
  • Nebraska
    • Omaha, Nebraska, United States
  • New Mexico
    • Albuquerque, New Mexico, United States
  • New York
    • Staten Island, New York, United States
  • Utah
    • Salt Lake City, Utah, United States
  • Washington
    • Bellevue, Washington, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

General Publications

• 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. doi: 10.1002/da.20209.

Study record dates

Study Major Dates

• Study Start: June 1, 2002
• Study Completion: August 1, 2002

Study Registration Dates

• First Submitted: July 31, 2002
• First Submitted That Met QC Criteria: August 2, 2002
• First Posted (Estimate): August 5, 2002

Study Record Updates

• Last Update Posted (Estimate): July 19, 2006
• Last Update Submitted That Met QC Criteria: July 18, 2006
• Last Verified: July 1, 2006

More Information

Terms related to this study

• Keywords: Sad, blue, lack of energy, depressed, hopelessness, guilt
• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder; Depressive Disorder, Major; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Antidepressive Agents; Dopamine Agents; Serotonin and Noradrenaline Reuptake Inhibitors; Duloxetine Hydrochloride
• Other Study ID Numbers: 6475; F1J-US-HMBY