Switching to Duloxetine in Patients With Depression (ARDENT)
This study has been completed.
Sponsor:
Eli Lilly and Company
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
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Depressive Disorder, Major |
Drug: Duloxetine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Attributes of Response in Depressed Patients Switched to Treatment With Duloxetine (ARDENT Study) |
Resource links provided by NLM:
Further study details as provided by Eli Lilly and Company:
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 [ Time Frame: Baseline, 4 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 4 Weeks, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]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 [ Time Frame: Baseline, 4 weeks, 8 weeks ] [ Designated as safety issue: No ]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.
| Enrollment: | 242 |
| Study Start Date: | June 2008 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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. Other Names:
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00696774
Locations
| 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. | |
| Guri City, Korea, Republic of, 471-701 | |
| 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, Korea, Republic of, 136 705 | |
Sponsors and Collaborators
Eli Lilly and Company
Investigators
| Study Director: | 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) | Eli Lilly and Company |
More Information
Additional Information:
No publications provided
| Responsible Party: | Chief Medical Officer, Eli Lilly |
| ClinicalTrials.gov Identifier: | NCT00696774 History of Changes |
| Other Study ID Numbers: | 12349, F1J-CR-S022 |
| 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) |
Additional relevant MeSH terms:
|
Depressive Disorder Depression Depressive Disorder, Major Mood Disorders Mental Disorders Behavioral Symptoms Duloxetine Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |
Pharmacologic Actions Serotonin Agents Physiological Effects of Drugs Adrenergic Uptake Inhibitors Adrenergic Agents Dopamine Uptake Inhibitors Dopamine Agents Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013