A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms
NCT ID: NCT01000805
Last Updated: 2012-01-13
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
528 participants
Study Classification
INTERVENTIONAL
Study Start Date
2009-11-30
Study Completion Date
2010-10-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Major Depressive Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
TRIPLE
Participants
Caregivers
Investigators
Study Groups
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Duloxetine
Group Type
EXPERIMENTAL
Duloxetine
Intervention Type
DRUG
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
Placebo
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Participants received placebo QD, po for 8 weeks.
Interventions
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Duloxetine
Participants received 30 mg duloxetine once daily (QD) by mouth (po) for 1 week followed by 60 mg QD, po for 7 weeks.
Intervention Type
DRUG
Placebo
Participants received placebo QD, po for 8 weeks.
Intervention Type
DRUG
Other Intervention Names
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LY248686
Cymbalta
Eligibility Criteria
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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
* 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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Beverly Hills, California, United States
Site Status
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Sherman Oaks, California, United States
Site Status
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Jacksonville, Florida, United States
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West Palm Beach, Florida, United States
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Indianapolis, Indiana, United States
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Lafayette, Indiana, United States
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Prairie Village, Kansas, United States
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Baltimore, Maryland, United States
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Cedarhurst, New York, United States
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New York, New York, United States
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Staten Island, New York, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Lake Jackson, Texas, United States
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Seattle, Washington, United States
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Brown Deer, Wisconsin, United States
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Arcachon, , France
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Élancourt, , France
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Strasbourg, , France
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Toulon, , France
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Aalen, , Germany
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Alzenau in Unterfranken, , Germany
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Dresden, , Germany
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Ellwangen, , Germany
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Hamburg, , Germany
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Hanover, , Germany
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Leipzig, , Germany
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Ponce, , Puerto Rico
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San Juan, , Puerto Rico
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Bucharest, , Romania
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Craiova, , Romania
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Iași, , Romania
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Târgovişte, , Romania
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Luleå, , Sweden
Site Status
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Lund, , Sweden
Site Status
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Malmo, , Sweden
Site Status
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Stockholm, , Sweden
Site Status
Countries
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United States
France
Germany
Puerto Rico
Romania
Sweden
References
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Dmitrienko A, Offen WW, Westfall PH. Gatekeeping strategies for clinical trials that do not require all primary effects to be significant. Stat Med. 2003 Aug 15;22(15):2387-400. doi: 10.1002/sim.1526.
Reference Type
BACKGROUND
Gaynor PJ, Gopal M, Zheng W, Martinez JM, Robinson MJ, Marangell LB. A randomized placebo-controlled trial of duloxetine in patients with major depressive disorder and associated painful physical symptoms. Curr Med Res Opin. 2011 Oct;27(10):1849-58. doi: 10.1185/03007995.2011.609539. Epub 2011 Aug 12.
Reference Type
DERIVED
Other Identifiers
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F1J-US-HMGR
Identifier Type: OTHER
Identifier Source: secondary_id
13399
Identifier Type: -
Identifier Source: org_study_id
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