Switching to Duloxetine in Patients With Depression (ARDENT)

• Mean baseline to endpoint change in Brief Pain Inventory-Modified Short Form interference scores (Item 5) between MAIER responders and non-responders patients [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• HAMD-17 Maier Subscale (Items 1, 2, 7, 8, 9, and 10) response: defined as ≥50% reduction from baseline [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

• Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks [ Time Frame: Baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  The Maier subscale (Items 1,2,7,8,9,10) represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Response is defined as a >=50% reduction in the Maier subscale score from baseline.
• Change From Baseline HAMD-17 Total Score at 8 Weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  The HAMD-17 total score measures depression severity. Each item was evaluated and scored using either a 5-point scale (e.g. absent, mild, moderate, severe, very severe) or a 3-point scale (e.g. absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline HAMD-17 Core Subscale at 8 Weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  The Core subscale (Items 1,2,3,7,8) evaluates "core" symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline HAMD-17 Maier Subscale at 8 Weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  The Maier subscale (Items 1,2,7,8,9,10) represents the "core" symptoms of depression. Total subscale scores range from 0 (normal) to 24 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifistations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  The Retardation Subscale (Items 1,7,8,14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation. Total subscale scores range from 0 (normal) to 14 (severe). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  The HAMA scale measures anxiety symptoms accompanying major depressive disorder (MDD). Each item of the 14-item HAMA was scored from 0 (not present) to 4 (very severe), with a resulting maximum total score of 56. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]
  A self-reported scale that measures the severity of pain based on the average pain experienced over the past 24-hours. The severity scores range from 0 (no pain) to 10 (pain as severe as you can imagine). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  A scale that measures the patient's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks [ Time Frame: Baseline, 4 Weeks, 8 weeks ] [ Designated as safety issue: No ]
  A 14-item patient-rated scale assesses medication-related changes in sexual activity/functioning. Items rated from 1 (never, low enjoyment/pleasure) to 5 (every day, great enjoyment/pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. Lower total scores are associated with diminished sexual functioning. Total scores <=47 (men) and <=41 (women) indicate global sexual dysfunction, with all phases of sexual response cycle affected. Factors used for adjustment for least squares means are in 'Other relevant information' section.
• Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks [ Time Frame: Baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  The TSQM is a participant-reported measure that best describes how the study medication makes them feel since the last study visit, assessing perceived effectiveness, severity of side effects, and convenience. Convenience, Effectiveness, Side-Effects, and Global Satisfaction scale scores range from 0 (extremely dissatisfied) to 100 (extremely satisfied). Factors used for adjustment for least squares means are listed in 'Other relevant information' section.
• Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks [ Time Frame: Baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]
  The SDS is completed by the patient and is used to assess the effect of the patient's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the patient's work/social/family life. Factors used for adjustment for least squares means are listed in 'Other relevant information' section.

• Depression severity: 17-item Hamilton Depression Rating Scale (HAMD17) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
• HAMD-17 Core Subscale (Items 1, 2, 3, 7, and 8): Core symptoms of depression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
• HAMD-17 Maier Subscale (Items 1, 2, 7, 8, 9, and 10): Core symptoms of depression [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
• Anxiety/Somatization subscale of the HAMD-17 (Items 10, 11, 12, 13, 15, and 17) evaluates severity of psychic and somatic manifestations of anxiety, as well as agitation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Retardation/Somatization subscale (Items 1, 7, 8, and 14) evaluates dysfunction in mood, work, and sexual activity, as well as overall motor retardation [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Sleep subscale of the HAMD-17 (Items 4, 5, and 6) evaluates initial, middle, and late insomnia [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Hamilton Anxiety Rating Scale (HAM-A) measures the presence and severity of anxiety [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• CGI-Severity: Clinical Global Impression - Severity [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Brief Pain Inventory: Modified Short Form (BPI-SF) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Patient Global Impression-Improvement (PGI - Improvement) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
• Changes in Sexual Functioning Questionnaire Clinical Version - CSFQ (Male and Female): Quality of Life [ Time Frame: At Baseline, 4 weeks post baseline and 8 weeks post baseline (or Early Discontinuation) ] [ Designated as safety issue: No ]
• TSQM - Treatment Satisfaction Questionnaire for Medication [ Time Frame: At Baseline, 4 weeks post baseline and 8 weeks post baseline (or Early Discontinuation) ] [ Designated as safety issue: No ]
• Sheehan Disability Scale [ Time Frame: At Baseline, 4 weeks post baseline and 8 weeks post baseline (or Early Discontinuation) ] [ Designated as safety issue: No ]

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.

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.