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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
242
Study Period II (Acute Therapy): 60 mg capsules, QD, for 4 weeks. Study Period III (Optimization): Responder group - 60 mg capsules, QD, for 4 weeks more. Non-responder group - 120 mg capsules, QD, for 4 weeks more.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Guri-si, South Korea
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Seoul, South Korea
Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks
BPI-SF interference score asks about the degree to which pain interferes with mood, walking and other physical activity, work, social activity, relations with others, and sleep. BPI-SF interference score ranges from 0 (no interference) to 10 (interferes completely). Response is defined as a \>=50% reduction in the Maier subscale score from baseline. The Maier subscale (Items 1,2,7,8,9,10) represents "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.
Time frame: Baseline, 4 weeks
Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks
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.
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline HAMD-17 Total Score at 8 Weeks
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.
Time frame: Baseline, 8 weeks
Change From Baseline HAMD-17 Core Subscale at 8 Weeks
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.
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Time frame: Baseline, 8 weeks
Change From Baseline HAMD-17 Maier Subscale at 8 Weeks
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.
Time frame: Baseline, 8 weeks
Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks
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.
Time frame: Baseline, 8 weeks
Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks
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.
Time frame: Baseline, 8 weeks
Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks
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.
Time frame: Baseline, 8 weeks
Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks
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.
Time frame: Baseline, 8 weeks
Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks
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.
Time frame: Baseline, 8 weeks
Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks
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.
Time frame: Baseline, 8 weeks
Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks
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.
Time frame: 8 weeks
Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks
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.
Time frame: Baseline, 4 Weeks, 8 weeks
Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks
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.
Time frame: Baseline, 4 weeks, 8 weeks
Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks
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.
Time frame: Baseline, 4 weeks, 8 weeks