Status:
COMPLETED
A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms
Lead Sponsor:
Eli Lilly and Company
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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- Previously completed or withdrawn from this study or any other study investigating duloxetine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
- Uncontrolled narrow-angle glaucoma
- Positive urine drug screen for any substance of abuse.
- A serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or a clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention
- A history of substance abuse or dependence within 1 year before being screened for the study
- History of a serious suicide attempt or subject judged clinically to be at serious suicidal risk
- Require continuous use of opioid analgesics for 6 or more months because of chronic pain
- Pain of a known origin
- Meets criteria for fibromyalgia as defined by the American College of Rheumatology
- Experiences greater than or equal to 1 migraine headache per week
- Have had electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), or vagus nerve stimulation (VNS) within 1 year prior to being screened for the study
- Initiating, changing, or stopping psychotherapy within 6 weeks prior to being screened for the study or at any time during the study
- Investigator or subject anticipates initiating, changing, or stopping non-pharmacologic or alternative therapies for painful physical symptoms at any time during the study
- Are taking any excluded medications within 7 days prior to randomization with the exception of fluoxetine which cannot be taken within 30 days prior to randomization
- Treatment with a monoamine oxidase inhibitor (MAOI) within 14 days prior to randomization or have the potential need to use an MAOI during the study or within 5 days of discontinuing study drug
- Frequent and/or severe allergic reactions with multiple medications
- Abnormal thyroid stimulating hormone concentration
- Has epilepsy or history of seizure disorder or received treatment with anticonvulsant medication for epilepsy or seizures
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
528 Patients enrolled
Trial Details
Trial ID
NCT01000805
Start Date
November 1 2009
End Date
October 1 2010
Last Update
January 13 2012
Active Locations (37)
Enter a location and click search to find clinical trials sorted by distance.
1
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, 90210
2
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.
Sherman Oaks, California, United States, 91403
3
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.
Jacksonville, Florida, United States, 32216
4
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.
West Palm Beach, Florida, United States, 33407