Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder

This study has been completed.

Sponsor:

Collaborator:

Boehringer Ingelheim Pharmaceuticals

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00105989

First received: March 18, 2005

Last updated: July 21, 2009

Last verified: July 2009

History of Changes

Results First Received: January 23, 2009

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition:	Depressive Disorder, Major
Interventions:	Drug: Duloxetine Drug: placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
The Acute - Open Label (Week 0-10) participants were reported in the Baseline Characteristics section of this results record.

Reporting Groups

	Description
Duloxetine	duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
Placebo	duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.

Participant Flow for 3 periods

Period 1: Acute - Open Label: Week 0-10

	Duloxetine	Placebo
STARTED	514	0
COMPLETED	413	0
NOT COMPLETED	101	0
Adverse Event	33	0
Withdrawal by Subject	24	0
Lack of Efficacy	17	0
Protocol Response Criteria Not Met	14	0
Protocol Violation	8	0
Lost to Follow-up	4	0
Physician Decision	0	0
Death	1	0
Recurrence Criteria Met	0	0
Unspecified - no reason reported	0	0

Period 2: Continuation - Open Label:Week 10-34

	Duloxetine	Placebo
STARTED	413	0
COMPLETED	288	0
NOT COMPLETED	125	0
Adverse Event	25	0
Withdrawal by Subject	50	0
Lack of Efficacy	15	0
Protocol Response Criteria Not Met	16	0
Protocol Violation	5	0
Lost to Follow-up	9	0
Physician Decision	3	0
Death	0	0
Recurrence Criteria Met	2	0
Unspecified - no reason reported	0	0

Period 3: Maintenance - Double-Blind:Week 34-86

	Duloxetine	Placebo
STARTED	146	142
COMPLETED	96	73
NOT COMPLETED	50	69
Adverse Event	6	3
Withdrawal by Subject	17	18
Lack of Efficacy	0	0
Protocol Response Criteria Not Met	0	0
Protocol Violation	5	4
Lost to Follow-up	4	0
Physician Decision	4	1
Death	0	0
Recurrence Criteria Met	14	43
Unspecified - no reason reported	0	0

Baseline Characteristics

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Reporting Groups

	Description
Duloxetine	duloxetine 60-120 mg QD

Baseline Measures

	Duloxetine
Number of Participants [units: participants]	514
Age [units: years] Mean ± Standard Deviation	47.6 ± 13.3
Gender [units: participants]
Female	359
Male	155
Region of Enrollment [units: participants]
United States	61
France	65
Russian Federation	99
Germany	161
Italy	73
Sweden	55
Race/Ethnicity [units: participants]
Caucasian	504
Hispanic	5
African	3
South Asian	1
East Asian	1
17-item Hamilton Depression Rating Scale (HAMD-17) Total Score ^[1] [units: units on a scale] Mean ± Standard Deviation	23.07 ± 3.57
Age at First Episode [units: years] Mean ± Standard Deviation	33.16 ± 13.38
Clinical Global Impressions - Severity (CGI-S) Total Score ^[2] [units: units on a scale] Mean ± Standard Deviation	4.49 ± 0.6
Duration of Current Episode [units: months] Mean ± Standard Deviation	4.02 ± 4.65
Duration of Last Episode [units: months] Mean ± Standard Deviation	6.14 ± 5.29
Height [units: centimeters] Mean ± Standard Deviation	167.6 ± 9.23
Number of Previous Episodes [units: previous episodes] Mean ± Standard Deviation	4.22 ± 3.48
Time Interval Between Episodes [units: months] Mean ± Standard Deviation	8.38 ± 6.78
Weight [units: kilograms] Mean ± Standard Deviation	74.7 ± 16.1

[1]	The 17-item HAMD measures depression severity. Each item was evaluated and scored using either a 5-point scale (absent, mild, moderate, severe, very severe) or a 3-point scale (absent, mild, marked). The total score of HAMD-17 may range from 0 (normal) to 52 (severe).
[2]	Measures severity of illness at the time of assessment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).

Outcome Measures

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1. Primary:

Percentage of Participants With Depressive Recurrence After Time (t) in Days [ Time Frame: Every Visit from Week 34 up to Week 86 (Maintenance Phase) ]

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2. Secondary:

Recurrence Count [ Time Frame: Every Visit from Week 35 up to Week 86 (Maintenance Phase) ]

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3. Secondary:

Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days [ Time Frame: Every Visit from Week 34 up to Week 86 (Maintenance Phase) ]

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4. Secondary:

Loss of Response at Any Time [ Time Frame: Every Visit from Week 35 up to Week 86 (Maintenance Phase) ]

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5. Secondary:

Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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6. Secondary:

Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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7. Secondary:

Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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8. Secondary:

Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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9. Secondary:

Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases [ Time Frame: Week 10 (Acute) and Week 34 (Continuation) ]

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10. Secondary:

Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase [ Time Frame: Week 86 (Maintenance Phase) ]

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11. Secondary:

Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

Show Outcome Measure 11

12. Secondary:

Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

Show Outcome Measure 12

13. Secondary:

Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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Measure Type	Secondary
Measure Title	Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
Measure Description	VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 100 millimeter (mm) line between two anchors (0 = no pain and 100 = very severe pain).
Time Frame	Week 0 and Week 10 (Acute) and Week 34 (Continuation)
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Number of enrolled patients in the Acute Phase with a baseline and at least one non-missing post-baseline measurement. Number of patients who entered Continuation phase with baseline and have at least 1 post-baseline measurement. Intent to Treat analysis.

Reporting Groups

	Description
Duloxetine - Acute Phase	duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
Duloxetine - Continuation Phase	duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)

Measured Values

	Duloxetine - Acute Phase	Duloxetine - Continuation Phase
Number of Participants Analyzed [units: participants]	450	410
Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase [units: units on a scale] Mean ± Standard Deviation
Overall Pain Baseline (N=450, N=410)	34.36 ± 26.16	17.29 ± 20.20
Overall Pain Change from Baseline to Endpoint	-16.34 ± 26.95	1.16 ± 21.33
Headache Baseline (N=450, N=410)	29.74 ± 28.08	14.80 ± 20.53
Headache Change from Baseline to Endpoint	-14.83 ± 28.04	0.04 ± 21.88
Back Pain Baseline (N=450, N=410)	28.79 ± 27.80	15.61 ± 22.63
Back Pain Change from Baseline to Endpoint	-13.64 ± 25.66	-0.00 ± 20.95
Shoulder Pain Baseline (N=446, N=410)	24.06 ± 27.23	13.49 ± 21.95
Shoulder Pain Change from Baseline to Endpoint	-10.47 ± 24.25	-0.39 ± 20.84
Interference-DailyActivities Baseline(N=445,N=410)	33.28 ± 28.31	15.59 ± 21.62
Intereference Change from Baseline to Endpoint	-16.79 ± 29.77	1.00 ± 21.43
Pain While Awake Baseline (N=446, N=410)	38.18 ± 29.29	19.22 ± 25.63
Pain While Awake Change from Baseline to Endpoint	-17.66 ± 31.22	0.06 ± 25.61

Statistical Analysis 1 for Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase

Groups ^[1]	Duloxetine - Acute Phase
Method ^[2]	t-test, 2 sided
P Value ^[3]	<0.001

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value for all Change from Baseline to Endpoint measures in the Acute Phase were <0.001.

Statistical Analysis 2 for Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase

Groups ^[1]	Duloxetine - Continuation Phase
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.273

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value for Overall Pain Change from Baseline to Endpoint.

Statistical Analysis 3 for Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase

Groups ^[1]	Duloxetine - Continuation Phase
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.968

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value for Headache Change from Baseline to Endpoint.

Statistical Analysis 4 for Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase

Groups ^[1]	Duloxetine - Continuation Phase
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.998

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value for Back Pain Change from Baseline to Endpoint.

Statistical Analysis 5 for Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase

Groups ^[1]	Duloxetine - Continuation Phase
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.703

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value for Shoulder Pain Change from Baseline to Endpoint.

Statistical Analysis 6 for Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase

Groups ^[1]	Duloxetine - Continuation Phase
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.346

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value for Interference with Daily Activities Change from Baseline to Endpoint.

Statistical Analysis 7 for Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase

Groups ^[1]	Duloxetine - Continuation Phase
Method ^[2]	t-test, 2 sided
P Value ^[3]	0.963

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	No text entered.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	t-test assesses if within treatment mean changes from baseline to endpoint are significantly different from zero.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	P-value for Pain While Awake Change from Baseline to Endpoint.

14. Secondary:

Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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15. Secondary:

Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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16. Secondary:

Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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17. Secondary:

Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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18. Secondary:

Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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19. Secondary:

Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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20. Secondary:

Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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21. Secondary:

Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases [ Time Frame: Week 0 through Week10 (Acute) through Week 34 (Continuation) ]

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22. Secondary:

Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase [ Time Frame: Week 34 through Week 86 (Maintenance Phase) ]

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23. Secondary:

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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24. Secondary:

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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25. Secondary:

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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26. Secondary:

Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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27. Secondary:

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males) [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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28. Secondary:

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females) [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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29. Secondary:

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males) [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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30. Secondary:

Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females) [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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31. Secondary:

Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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32. Secondary:

Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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33. Secondary:

Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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34. Secondary:

Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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35. Secondary:

Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases [ Time Frame: Week 0 and Week 10 (Acute) and Week 34 (Continuation) ]

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36. Secondary:

Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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37. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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38. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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39. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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40. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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41. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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42. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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43. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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44. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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45. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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46. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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47. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase [ Time Frame: Week 0 and Week 10 ]

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48. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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49. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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50. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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51. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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52. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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53. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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54. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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55. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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56. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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57. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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58. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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59. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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60. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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61. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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62. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase [ Time Frame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase) ]

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63. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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64. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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65. Secondary:

Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase [ Time Frame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase) ]

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66. Secondary:

Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase [ Time Frame: Every Visit from Week 0 up to Week 10 (Acute) ]

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67. Secondary:

Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase [ Time Frame: Every Visit from Week 10 up to Week 34 (Continuation) ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
phone: 1-800-545-5979

No publications provided by Eli Lilly and Company

Publications automatically indexed to this study:

Perahia DG, Maina G, Thase ME, Spann ME, Wang F, Walker DJ, Detke MJ. Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 May;70(5):706-16.

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00105989 History of Changes
Other Study ID Numbers:	8606, F1J-MC-HMDI
Study First Received:	March 18, 2005
Results First Received:	January 23, 2009
Last Updated:	July 21, 2009
Health Authority:	United States: Food and Drug Administration

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