Switching to Duloxetine in Patients With Depression (ARDENT)

This study has been completed.

Sponsor:

Information provided by:

Eli Lilly and Company

ClinicalTrials.gov Identifier:

NCT00696774

First received: June 11, 2008

Last updated: September 2, 2010

Last verified: September 2010

History of Changes

Results First Received: July 15, 2010

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Depressive Disorder, Major
Intervention:	Drug: Duloxetine

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
270 participants began the study. 26 were screen failures (17 did not meet entry criteria, 7 decided to withdraw, and 2 withdrew based on the physician's decision). 2 participants discontinued before enrollment (1 was lost to follow-up and 1 decided to withdraw).

Reporting Groups

	Description
Responders	60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
Non-Responders	60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-Responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
Unclassified	Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.

Participant Flow for 2 periods

Period 1: Period II

	Responders	Non-Responders	Unclassified
STARTED	115	91	36 ^[1]
COMPLETED	115	91	0
NOT COMPLETED	0	0	36
Adverse Event	0	0	15
Lost to Follow-up	0	0	4
Protocol Violation	0	0	11
Withdrawal by Subject	0	0	4
Sponsor Decision	0	0	0
Lack of Efficacy	0	0	2

[1]	1 participant did not receive study drug and was not included in the safety analyses.

Period 2: Period III

	Responders	Non-Responders
STARTED	113 ^[1]	88 ^[2]
COMPLETED	106	81 ^[3]
NOT COMPLETED	7	7
Adverse Event	1	1
Lost to Follow-up	2	1
Protocol Violation	1	1
Withdrawal by Subject	1	2
Sponsor Decision	2	0
Lack of Efficacy	0	2

[1]	115 reported at Week 4; 113 started Period 3 (1 lost to follow-up and 1 protocol violation).
[2]	91 reported at Week 4; 88 start Period 3 (1 adverse event, 1 protocol violation, 1 lack of efficacy)
[3]	82 participants were reported at Week 8; 81 completed Week 8 as 1 participant decided to withdraw.

Baseline Characteristics

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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.
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Reporting Groups

	Description
Duloxetine Responders	60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II). Responder group - 60 mg capsules, QD, for 4 weeks more (Study Period III).
Duloxetine Non-Responders	60 mg duloxetine capsules, QD, for 4 weeks (Study Period II). Non-responder group - 120 mg capsules, QD, for 4 weeks more (Study Period III).
Unclassified	Participants who received 60 milligram (mg) duloxetine capsules, once daily (QD), for 4 weeks (Study Period II) with unknown response status.
Total	Total of all reporting groups

Baseline Measures

	Duloxetine Responders	Duloxetine Non-Responders	Unclassified	Total
Number of Participants [units: participants]	115	91	36	242
Age [units: years] Mean (Standard Deviation)	43.5 (12.9)	45.6 (12.5)	47.4 (10.6)	44.9 (12.5)
Gender [units: participants]
Female	88	64	30	182
Male	27	27	6	60
Race/Ethnicity, Customized [units: participants]
Caucasian	67	66	17	150
East Asian	43	23	12	78
African	1	0	2	3
Hispanic	2	2	3	7
West Asian	2	0	2	4
Region of Enrollment [units: participants]
Korea, Republic of	18	11	9	38
Brazil	9	11	13	33
China	25	13	3	41
Canada	63	56	11	130
Had Major Depressive Disorder (MDD) Hospitalizations in the Past 24 Months [units: participants]
Yes	8	5	2	15
No	107	86	34	227
Had Previous MDD in the Past 24 Months [units: participants]
Yes	79	54	24	157
No	36	37	12	85
Had at Least One Historical Illness [units: participants]
Yes	44	32	15	91
No	71	59	21	151
Previous Treatment ^[1] [units: participants]
SSRI	83	69	25	177
SNRI	31	21	9	61
Missing or Unknown	1	1	2	4
17-Item Hamilton Depression Rating Scale (HAMD-17) Anxiety/Somatization Score ^[2] [units: units on a scale] Mean (Standard Deviation)	7.7 (2.1)	8.0 (2.0)	7.4 (1.7)	7.8 (2.0)
17-Item Hamilton Depression Rating Scale (HAMD-17) Core Score ^[3] [units: units on a scale] Mean (Standard Deviation)	8.1 (2.6)	9.0 (2.6)	7.9 (2.8)	8.4 (2.7)
17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Score ^[4] [units: units on a scale] Mean (Standard Deviation)	10.7 (2.6)	11.7 (2.6)	10.0 (2.7)	11.0 (2.7)
17-Item Hamilton Depression Rating Scale (HAMD-17) Retardation Score ^[5] [units: units on a scale] Mean (Standard Deviation)	7.1 (2.1)	8.2 (1.9)	7.2 (2.4)	7.5 (2.1)
17-Item Hamilton Depression Rating Scale (HAMD-17) Sleep Score ^[6] [units: units on a scale] Mean (Standard Deviation)	3.1 (1.6)	3.4 (1.4)	3.2 (1.7)	3.2 (1.5)
17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score ^[7] [units: units on a scale] Mean (Standard Deviation)	21.3 (4.5)	23.3 (4.5)	20.7 (4.5)	21.9 (4.6)
Age of First Episode of MDD [units: years] Mean (Standard Deviation)	35.2 (11.7)	33.5 (13.6)	36.9 (12.8)	34.8 (12.6)
Brief Pain Inventory - Short Form (BPI-SF) Average Pain Score ^[8] [units: Units on a scale] Mean (Standard Deviation)	4.7 (1.9)	5.0 (2.0)	4.4 (2.2)	4.8 (2.0)
Brief Pain Inventory - Short Form Interference Score ^[9] [units: Units on a scale] Mean (Standard Deviation)	5.2 (1.6)	5.9 (1.8)	5.2 (1.9)	5.5 (1.8)
Changes in Sexual Function Questionnaire (CSFQ) ^[10] [units: Units on a scale] Mean (Standard Deviation)	35.3 (10.3)	35.4 (9.8)	33.8 (9.4)	35.1 (10.0)
Clinical Global Impressions - Severity (CGI-Severity) Score ^[11] [units: Units on a scale] Mean (Standard Deviation)	4.2 (0.6)	4.4 (0.6)	4.3 (0.7)	4.3 (0.6)
Duration of the Current Episode [units: days] Mean (Standard Deviation)	249.4 (378.3)	264.5 (318.1)	194.1 (182.6)	247.3 (333.3)
Hamilton Anxiety Rating Scale (HAMA) Total Score ^[12] [units: Units on a scale] Mean (Standard Deviation)	17.9 (6.8)	21.4 (6.8)	17.9 (7.6)	19.2 (7.1)
Number of MDD Hospitalizations in the Past 24 Months [units: hospitalizations] Mean (Standard Deviation)	1.0 (0.0)	1.0 (0.0)	1.0 (0.0)	1.0 (0.0)
Number of Previous MDD Episodes in the Past 24 Months [units: MDD episodes] Mean (Standard Deviation)	1.6 (0.8)	1.5 (0.7)	1.8 (1.5)	1.6 (0.9)
Sheehan Disability Scale (SDS) ^[13] [units: Units on a scale] Mean (Standard Deviation)	5.4 (2.9)	6.3 (3.0)	5.5 (3.0)	5.7 (3.0)
Treatment Satisfaction Questionnaire for Medication (TSQM) ^[14] [units: Units on a scale] Mean (Standard Deviation)	44.2 (17.6)	41.6 (18.2)	47.2 (20.8)	43.7 (18.3)

[1]	Previous selective serotonin reuptake inhibitor (SSRI) or serotonin norepinephrine reuptake inhibitor (SNRI) treatment.
[2]	The Anxiety/Somatization Subscale (Items 10-13, 15, 17) evaluates severity of psychic and somatic manifestations of anxiety as well as agitation. Total subscale scores range from 0 (normal) to 18 (severe).
[3]	The Core subscale (Items 1,2,3,7,8) evaluates "core" symptoms of depression. Total subscale scores range from 0 (normal) to 20 (severe).
[4]	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).
[5]	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).
[6]	The Sleep Subscale (Items 4,5,6) evaluates initial, middle, and late insomnia. Total subscale scores range from 0 (no difficulty) to 6 (difficulty).
[7]	The HAMD-17 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).
[8]	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).
[9]	The 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).
[10]	A 14-item patient-rated scale designed to assess medication-related changes in sexual activity/functioning. Items are rated from 1 (never, low enjoyment or pleasure) to 5 (every day/great enjoyment or pleasure). CSFQ measures 5 dimensions of sexual behavior: pleasure; desire/frequency; desire/interest; arousal; orgasm. CSFQ total score is obtained across all 5 dimensions. Lower scores are associated with sexual dysfunction/diminished sexual functioning. Total scores <=47 (men) and <=41 (women) indicate global sexual dysfunction, with all phases of the sexual response cycle being affected.
[11]	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).
[12]	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.
[13]	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.
[14]	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).

Outcome Measures

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1. Primary:

Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks [ Time Frame: Baseline, 4 weeks ]

Show Outcome Measure 1

2. 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 [ Time Frame: Baseline, 4 weeks, 8 weeks ]

Show Outcome Measure 2

3. Secondary:

Change From Baseline HAMD-17 Total Score at 8 Weeks [ Time Frame: Baseline, 8 weeks ]

Show Outcome Measure 3

4. Secondary:

Change From Baseline HAMD-17 Core Subscale at 8 Weeks [ Time Frame: Baseline, 8 weeks ]

Show Outcome Measure 4

5. Secondary:

Change From Baseline HAMD-17 Maier Subscale at 8 Weeks [ Time Frame: Baseline, 8 weeks ]

Show Outcome Measure 5

6. Secondary:

Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks [ Time Frame: Baseline, 8 weeks ]

Show Outcome Measure 6

7. Secondary:

Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks [ Time Frame: Baseline, 8 weeks ]

Show Outcome Measure 7

8. Secondary:

Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks [ Time Frame: Baseline, 8 weeks ]

Show Outcome Measure 8

9. Secondary:

Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks [ Time Frame: Baseline, 8 weeks ]

Show Outcome Measure 9

10. Secondary:

Change From Baseline in the Clinical Global Impression – Severity (CGI-Severity) Scale at 8 Weeks [ Time Frame: Baseline, 8 weeks ]

Show Outcome Measure 10

11. Secondary:

Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks [ Time Frame: Baseline, 8 weeks ]

Show Outcome Measure 11

12. Secondary:

Change From Baseline in Patient Global Impression - Improvement (PGI–I) Scale Score at 8 Weeks [ Time Frame: 8 weeks ]

Show Outcome Measure 12

13. Secondary:

Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks [ Time Frame: Baseline, 4 Weeks, 8 weeks ]

Show Outcome Measure 13

14. Secondary:

Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks [ Time Frame: Baseline, 4 weeks, 8 weeks ]

Show Outcome Measure 14

15. Secondary:

Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks [ Time Frame: Baseline, 4 weeks, 8 weeks ]

Show Outcome Measure 15

Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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
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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.

Results Point of Contact:

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

Responsible Party:	Chief Medical Officer, Eli Lilly
ClinicalTrials.gov Identifier:	NCT00696774 History of Changes
Other Study ID Numbers:	12349 F1J-CR-S022 ( Other Identifier: Eli Lilly and Company )
Study First Received:	June 11, 2008
Results First Received:	July 15, 2010
Last Updated:	September 2, 2010
Health Authority:	Brazil: National Health Surveillance Agency Canada: Health Canada China: Food and Drug Administration South Korea: Korea Food and Drug Administration (KFDA)

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