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CompletedNCT00696774ARDENTUpdated Sep 8, 2010Results posted

Switching to Duloxetine in Patients With Depression

A Phase 4 interventional study of Duloxetine in Depressive Disorder, Major, sponsored by Eli Lilly and Company. Completed at 2 sites in Korea, Republic of. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-08.

Sponsored by Eli Lilly and Company · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
242
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Depressive Disorder, Major
03

In context

Depressive Disorder

4,845 studies on the registry are indexed under Depressive Disorder; 514 are open to participants now.

This study's enrollment of 242 is above the median of 80 across 3,999 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
242 participants (actual)

Study arms

  • Experimental
    Duloxetine

    Patients who met criteria in Study Period I (screening) were treated with duloxetine 60 milligrams (mg) once daily (QD) in an open-label manner for 4 weeks (Study Period II). Study Period II was considered the acute therapy period. Study Period III was a 4-week interval where patients who did not respond during Study Period II had their duloxetine doses optimized to 120 mg.

    Drug: Duloxetine

Interventions

  • DrugDuloxetine

    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.

    Also known as: LY248686, Cymbalta

06

What researchers measure

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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.

    Time frame: Baseline, 8 weeks

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

07

Results

Posted Aug 11, 2010

Participant flow

Period II
Participant flow — Period II
MilestoneRespondersNon-RespondersUnclassified
Started1159136
Completed115910
Not completed0036
Withdrew: Adverse event0015
Withdrew: Lost to follow-up004
Withdrew: Protocol violation0011
Withdrew: Withdrawal by subject004
Withdrew: Sponsor decision000
Withdrew: Lack of efficacy002
Period III
Participant flow — Period III
MilestoneRespondersNon-RespondersUnclassified
Started113880
Completed106810
Not completed770
Withdrew: Adverse event110
Withdrew: Lost to follow-up210
Withdrew: Protocol violation110
Withdrew: Withdrawal by subject120
Withdrew: Sponsor decision200
Withdrew: Lack of efficacy020

Outcome measures

PrimaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
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 (-2.83 to -1.87)-1.69 (-2.18 to 1.21)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · p = 0.005 · Mean difference (final values): -0.66 · 95% CI -1.12 to -0.20Least Squares Mean Difference = Responders - Non-Responders.
SecondaryPercentage 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
Reported as:
Number · Percentage of participants
Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks
Percentage of participantsDuloxetine
Week 4 (n=193)56.0 (48.7 to 63.1)
Week 8 (n=179)73.7 (66.7 to 80.0)
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline HAMD-17 Total Score at 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Change From Baseline HAMD-17 Total Score at 8 Weeks-15.64 (-16.86 to -14.41)-9.79 (-11.10 to -8.47)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -5.85 · 95% CI -7.34 to -4.36Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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.

Time frame:
Baseline, 8 weeks
Reported as:
Least squares mean · Units on a scale
Change From Baseline HAMD-17 Core Subscale at 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Change From Baseline HAMD-17 Core Subscale at 8 Weeks-6.87 (-7.41 to -6.33)-4.40 (-4.99 to -3.81)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -2.47 · 95% CI -3.13 to -1.81Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline HAMD-17 Maier Subscale at 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Change From Baseline HAMD-17 Maier Subscale at 8 Weeks-8.58 (-9.25 to -7.90)-5.29 (-6.01 to -4.56)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -3.29 · 95% CI -4.10 to -2.48Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks-5.29 (-5.84 to -4.73)-3.07 (-3.68 to -2.47)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -2.22 · 95% CI -2.89 to -1.54Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks-5.51 (-5.98 to -5.05)-3.63 (-4.14 to -3.13)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -1.88 · 95% CI -2.45 to -1.30Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks-2.27 (-2.59 to -1.96)-1.31 (-1.64 to -0.97)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -0.97 · 95% CI -1.31 to -0.63Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks-12.97 (-14.37 to -11.56)-8.55 (-10.04 to -7.06)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -4.42 · 95% CI -6.04 to -2.80Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks-2.52 (-2.75 to -2.30)-1.40 (-1.65 to -1.14)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -1.13 · 95% CI -1.42 to -0.84Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks-2.56 (-3.13 to -1.99)-2.14 (-2.75 to -1.53)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -0.42 · 95% CI -1.08 to -0.24Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks2.12 (1.85 to 2.38)2.61 (2.33 to 2.90)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -0.49 · 95% CI -0.81 to -0.18Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Week 40.03 (-1.84 to 1.90)-0.78 (-2.76 to 1.21)
Week 81.08 (-0.90 to 3.05)-0.29 (-2.42 to 1.84)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): 0.81 · 95% CI -0.99 to 2.60Least Squares Mean Difference = Responders - Non-Responders.
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): 1.36 · 95% CI -0.69 to 3.42Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Week 417.64 (12.88 to 22.39)2.59 (-2.16 to 7.34)
Week 818.67 (13.37 to 23.97)8.19 (2.65 to 13.73)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): 15.05 · 95% CI 10.63 to 19.47Least Squares Mean Difference = Responders - Non-Responders.
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): 10.48 · 95% CI 4.72 to 16.24Least Squares Mean Difference = Responders - Non-Responders.
SecondaryChange 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
Reported as:
Least squares mean · Units on a scale
Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks
Units on a scaleDuloxetine RespondersDuloxetine Non-Responders
Week 4-8.38 (-10.26 to -6.50)-2.49 (-4.42 to -0.57)
Week 8-9.95 (-11.91 to -7.99)-5.36 (-7.40 to -3.32)
Statistical analysis
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -5.88 · 95% CI -7.75 to -4.02Least Squares Mean Difference = Responders - Non-Responders.
  • Duloxetine Responders vs Duloxetine Non-Responders · Adjusted Repeated Measures Analysis · Mean difference (final values): -4.59 · 95% CI -6.65 to -2.54Least Squares Mean Difference = Responders - Non-Responders.

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Duloxetine Responders—0/115 (0%)71/115 (61.7%)
Duloxetine Non-Responders—2/91 (2.2%)59/91 (64.8%)
Unclassified—0/35 (0%)22/35 (62.9%)
Most frequent serious events
Most frequent serious events
EventDuloxetine RespondersDuloxetine Non-RespondersUnclassified
DepressionPsychiatric disorders0/1151/910/35
DermatitisSkin and subcutaneous tissue disorders0/1151/910/35
Most frequent other events
Showing 10 of 17
Most frequent other events
EventDuloxetine RespondersDuloxetine Non-RespondersUnclassified
NauseaGastrointestinal disorders20/11515/917/35
HeadacheNervous system disorders15/11515/912/35
Dry mouthGastrointestinal disorders12/11514/910/35
DizzinessNervous system disorders15/11510/915/35
ConstipationGastrointestinal disorders13/1159/911/35
InsomniaPsychiatric disorders10/11510/911/35
FatigueGeneral disorders3/1157/913/35
SomnolenceNervous system disorders8/1157/913/35
AnxietyPsychiatric disorders3/1156/910/35
Abdominal pain upperGastrointestinal disorders1/1152/912/35

Baseline characteristics

Age Continuous
Age Continuous(years)Duloxetine RespondersDuloxetine Non-RespondersUnclassifiedTotal
Mean43.5 ± 12.945.6 ± 12.547.4 ± 10.644.9 ± 12.5
Sex: Female, Male
Sex: Female, Male(Participants)Duloxetine RespondersDuloxetine Non-RespondersUnclassifiedTotal
Female886430182
Male2727660
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)Duloxetine RespondersDuloxetine Non-RespondersUnclassifiedTotal
Caucasian676617150
East Asian43231278
African1023
Hispanic2237
West Asian2024
Region of Enrollment
Region of Enrollment(participants)Duloxetine RespondersDuloxetine Non-RespondersUnclassifiedTotal
Korea, Republic of1811938
Brazil9111333
China2513341
Canada635611130
Had Major Depressive Disorder (MDD) Hospitalizations in the Past 24 Months
Had Major Depressive Disorder (MDD) Hospitalizations in the Past 24 Months(participants)Duloxetine RespondersDuloxetine Non-RespondersUnclassifiedTotal
Yes85215
No1078634227
Had Previous MDD in the Past 24 Months
Had Previous MDD in the Past 24 Months(participants)Duloxetine RespondersDuloxetine Non-RespondersUnclassifiedTotal
Yes795424157
No36371285
Had at Least One Historical Illness
Had at Least One Historical Illness(participants)Duloxetine RespondersDuloxetine Non-RespondersUnclassifiedTotal
Yes44321591
No715921151
Previous Treatment
Previous Treatment(participants)Duloxetine RespondersDuloxetine Non-RespondersUnclassifiedTotal
SSRI836925177
SNRI3121961
Missing or Unknown1124

17 further baseline measures are reported on the registry.

08

Study locations

2 sites
  • 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 City, 471-701, Korea, Republic of
  • 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, 136 705, Korea, Republic of
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 8, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00696774
Lead sponsor
Eli Lilly and Company
First posted
Jun 13, 2008
Start date
Jun 2008
Primary completion
Jul 2009
Completion
Jul 2009
Results posted
Aug 11, 2010
Last update
Sep 8, 2010

Study contacts

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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