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
  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:
  • LY248686
  • Cymbalta

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antidepressive Agents
Psychotropic Drugs
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Adrenergic Uptake Inhibitors
Adrenergic Agents
Dopamine Uptake Inhibitors
Dopamine Agents

ClinicalTrials.gov processed this record on October 19, 2014