Phase 4
Completed N=242
Switching to Duloxetine in Patients With Depression
Depressive Disorder, Major
Source: ClinicalTrials.gov NCT00696774 ↗
Enrolled (actual)
242
Serious AEs
0.8%
Results posted
Aug 2010
Primary outcomePrimary: Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks — -2.35; -1.69 Units on a scale — p=0.005
Summary
The purpose of this study is to help answer the following research question: Whether switching to duloxetine improves depressed mood when current treatment did not work well for patients with depression.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks |
-2.35; -1.69 | 0.005 sig |
| SECONDARY Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks |
56.0; 73.7 | — |
| SECONDARY Change From Baseline HAMD-17 Total Score at 8 Weeks |
-15.64; -9.79 | — |
| SECONDARY Change From Baseline HAMD-17 Core Subscale at 8 Weeks |
-6.87; -4.40 | — |
| SECONDARY Change From Baseline HAMD-17 Maier Subscale at 8 Weeks |
-8.58; -5.29 | — |
| SECONDARY Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks |
-5.29; -3.07 | — |
| SECONDARY Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks |
-5.51; -3.63 | — |
| SECONDARY Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks |
-2.27; -1.31 | — |
| SECONDARY Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks |
-12.97; -8.55 | — |
| SECONDARY Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks |
-2.52; -1.40 | — |
| SECONDARY Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks |
-2.56; -2.14 | — |
| SECONDARY Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks |
2.12; 2.61 | — |
| SECONDARY Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks |
0.03; -0.78; 1.08; -0.29 | — |
| SECONDARY Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks |
17.64; 2.59; 18.67; 8.19 | — |
| SECONDARY Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks |
-8.38; -2.49; -9.95; -5.36 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female outpatients aged 18 years or older who meet criteria for Major Depressive Disorder (MDD).
- Currently receiving a selective serotonin reuptake inhibitor (SSRI) or a serotonin-norepinephrine reuptake inhibitor (SNRI) class of antidepressant for at least a month for the treatment of depression.
- Females of child-bearing potential (not surgically sterilized and between menarche and 1 year postmenopause) to test negative for pregnancy based on a urine pregnancy test and to agree to use a reliable method of birth control.
Exclusion Criteria
- Women who are pregnant or plan to be pregnant or are breastfeeding.
- To have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication.
- Diagnosed with treatment resistant depression.
- History of bipolar disorder, schizophrenia, or other psychotic disorders.
- To have previously taken duloxetine that didn't work.
- Judged to be at serious suicidal risk in the opinion of the investigator and/or score >=3 on Item 3 (suicide) of the 17-Item Hamilton Depression Rating Scale (HAMD-17) at screening (Visit 1) or baseline (Visit 2).
- A serious medical illness that may need treatment during the study.
- Taking certain medications that are not allowed in this study.
- To have a history of alcohol and/or drug abuse or dependence within the past year.
- To have uncontrolled narrow-angle glaucoma.
- To have allergic reactions to many medicines.
- To have undergone "shock" therapy (Electroconvulsive Therapy) or "magnet" treatment (Transcranial Magnetic Stimulation) within the past year.
- To initiate "talk therapy" (psychotherapy) just before or during the study.
- To have chronic pain and you have been taking medicine for it for the last 6 months.
- To have certain liver diseases.
- To have kidney disease or undergoing dialysis.
- Abnormal thyroid stimulating hormone (TSH) concentration.
Data sourced from ClinicalTrials.gov (NCT00696774). 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.