A Study in Depression and Associated Painful Physical Symptoms

Lilly

Status and phase

Completed

Phase 4

Conditions

Major Depressive Disorder

Treatments

Drug: Duloxetine

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01070329

13630

F1J-US-HMGU (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

527 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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 the Mini International Neuropsychiatric Interview (MINI)
Montgomery-Asberg Depression Rating Scale (MADRS) total score 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
A Clinical Global Impression of Severity (CGI-S) score greater than or equal to 4 during the Screening Phase
Written informed consent

Key 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
Have previously completed or withdrawn from this study or any other study investigating duloxetine (unless no study drug was received)
Women of child-bearing potential who are not using a medically accepted means of contraception
Have any current (within past 6 months) DSM-IV-TR primary Axis I diagnosis other than MDD
Have a history of alcohol abuse and/or substance abuse or dependence within 1 year prior to being screened for the study
Have any prior history of bipolar disorder, psychosis, or schizophrenia
Have an Axis II disorder that would interfere with study compliance
Lack of response of any episode of major depression (lifetime of subject) to two or more adequate courses of antidepressant therapy, at a clinically appropriate dose for at least 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
Have a serious medical illness, including any cardiovascular, hepatic, renal, respiratory, hematologic, endocrinologic, or neurologic disease, or clinically significant laboratory abnormality that is not stabilized or is anticipated to require intervention, hospitalization, or use of an excluded medication during the study
History of a serious suicide attempt or subject judged clinically to be at serious suicidal risk
Requires continuous use of analgesics for 6 or more months because of chronic pain
Has 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 after discontinuation of study drug
Abnormal thyroid stimulating hormone
Has epilepsy or history of seizure disorder or received treatment with anticonvulsant medication for epilepsy or seizures