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A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms | Clinical Trials | Clareo Health

COMPLETEDPHASE4

A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms

A Phase 4, 8-Week, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients With Major Depressive Disorder and Associated Painful Physical Symptoms

NCT01000805•Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to find out if 60 mg of duloxetine given once a day by mouth for 8 weeks to patients diagnosed with major depressive disorder, who also report associated painful physical symptoms, is better than placebo when treating depression and its associated painful symptoms.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Meets criteria for Major Depressive Disorder (MDD) as defined by Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and confirmed by Mini International Neuropsychiatric Interview (MINI)
•Montgomery-Asberg Depression Rating Scale (MADRS) total score of greater than or equal to 20 during the Screening Phase
•At least 1 previous episode of depression
•Painful physical symptoms with a score greater than or equal to 3 on the Brief Pain Inventory-Short Form (BPI-SF) average pain question during the Screening Phase
•A Clinical Global Impression of Severity (CGI-S) score of greater than or equal to 4 during the Screening Phase
•Written informed consent

Exclusion Criteria

•Currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an off-label use of an investigational drug or device
•Previously completed or withdrawn from this study or any other study investigating duloxetine
•Women of child-bearing potential who are not using a medically accepted means of contraception
•Any current (within the past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD
•History of alcohol abuse or dependence within 1 year immediately prior to being screened for the study
•Any prior history of bipolar disorder, psychosis, or schizophrenia
•Have an Axis II disorder that would interfere with study compliance
•Lack of a response of any (lifetime of subject) episode of major depression greater than or equal to 2 adequate courses of antidepressant therapy, defined as a clinically appropriate dose for a minimum of 4 weeks or, alternatively, in the judgment of the investigator, the subject meets criteria for treatment-resistant depression
•Have previously received treatment of MDD or Generalized Anxiety Disorder (GAD) with an adequate trial of duloxetine and did not respond or could not tolerate duloxetine
•Diagnosis of acute liver injury or severe cirrhosis
+17 more criteria

Locations (37)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Beverly Hills, California, United States

Sherman Oaks, California, United States

Jacksonville, Florida, United States

West Palm Beach, Florida, United States

Indianapolis, Indiana, United States

Lafayette, Indiana, United States

Prairie Village, Kansas, United States

Baltimore, Maryland, United States

Cedarhurst, New York, United States

New York, New York, United States

Key Dates

Start Date

November 1, 2009

Primary Completion Date

October 1, 2010

Completion Date

October 1, 2010

Last Updated

January 13, 2012

Enrollment

528

ACTUAL participants

Conditions

Major Depressive Disorder

Interventions

Duloxetine

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms

Inclusion Criteria

Exclusion Criteria

A Phase 2 Study of Zelquistinel or Placebo for the Reduction of Symptoms of Major Depressive Disorder

A Study of a Deuterated Psilocin Analog (CYB003) in Humans With Major Depressive Disorder

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Virtual Reality-Based Mindfulness as an Adjunct to Treatment as Usual in Treatment-Resistant Depression