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Switching to Duloxetine in Patients With Depression (ARDENT)

Primary Purpose

Depressive Disorder, Major

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Duloxetine
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depressive Disorder, Major

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • 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.
  • 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.

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Duloxetine

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
June 11, 2008
Last Updated
September 2, 2010
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT00696774
Brief Title
Switching to Duloxetine in Patients With Depression
Acronym
ARDENT
Official Title
Attributes of Response in Depressed Patients Switched to Treatment With Duloxetine (ARDENT Study)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder, Major

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Enrollment
242 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Duloxetine
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Duloxetine
Other Intervention Name(s)
LY248686, Cymbalta
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks
Description
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 Outcome Measure Information:
Title
Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks
Description
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
Title
Change From Baseline HAMD-17 Total Score at 8 Weeks
Description
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
Title
Change From Baseline HAMD-17 Core Subscale at 8 Weeks
Description
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
Title
Change From Baseline HAMD-17 Maier Subscale at 8 Weeks
Description
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
Title
Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks
Description
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
Title
Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks
Description
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
Title
Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks
Description
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
Title
Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks
Description
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
Title
Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks
Description
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
Title
Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks
Description
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
Title
Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks
Description
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
Title
Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks
Description
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
Title
Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks
Description
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
Title
Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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.
City
Guri City
ZIP/Postal Code
471-701
Country
Korea, Republic of
Facility Name
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.
City
Seoul
ZIP/Postal Code
136 705
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Switching to Duloxetine in Patients With Depression

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