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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Duloxetine Hydrochloride

Criteria

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• Previously completed or withdrawn from this study or any other study investigating duloxetine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

• 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