Phase 4
Completed N=528
A Study of Duloxetine in Major Depressive Disorder (MDD) and Associated Painful Symptoms
Source: ClinicalTrials.gov NCT01000805 ↗Enrolled (actual)
528
Serious AEs
1.1%
Results posted
Jan 2012
Primary outcomePrimary: Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-week Treatment Period — -1.93; -1.31 units on a scale — p=<0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Brief Pain Inventory-Short Form (BPI-SF) Average Pain Score During the 8-week Treatment Period |
-1.93; -1.31 | <0.001 sig |
| PRIMARY Change From Baseline in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 8 |
-16.77; -12.73 | <0.001 sig |
| SECONDARY Change From Baseline in the Sheehan Disability Scale (SDS) Total and Item Scores at Week 8 |
-2.82; -2.36; -3.04; -2.31; -3.02; -2.49 | 0.112 |
| SECONDARY Change From Baseline in the Percentage of Participants Achieving Remission up to Week 8 |
47.0; 32.8 | 0.001 sig |
| SECONDARY Percentage of Participants Achieving Remission up to Week 8 |
29.5; 18.7 | 0.0082 sig |
| SECONDARY Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 4 |
-14.15; -10.49 | <0.001 sig |
| SECONDARY Change From Baseline in Montgomery Asberg Depression Rating Scale (MADRS) Total Score at Week 2 |
-9.90; -7.71 | 0.001 sig |
| SECONDARY Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 8 |
-2.25; -1.60; -1.48; -0.86; -1.93; -1.31 | <0.001 sig |
| SECONDARY Patient's Global Impressions of Improvement Scale (PGI-I) at Week 8 |
2.56; 3.04 | <0.001 sig |
| SECONDARY Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on the Columbia Suicide Severity Rating Scale (C-SSRS) During the Double-blind Treatment Phase |
26; 41; 1; 0; 2; 0 | 0.293 |
| SECONDARY Change From Baseline in Pulse Rate up to Week 8 |
1.58; -1.34; 1.71; -0.70 | <0.001 sig |
| SECONDARY Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) Up to Week 8 |
1.38; -0.52; 0.52; 0.05; 1.41; -0.12 | 0.083 |
| SECONDARY Change From Baseline in Weight up to Week 8 |
-0.77; 0.19; -0.74; 0.14 | <0.001 sig |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01000805). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.