Clinical trial NCT00696774: Switching to Duloxetine in Patients With Depression
Official title: Attributes of Response in Depressed Patients Switched to Treatment With Duloxetine (ARDENT Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depressive Disorder, Major
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-06-13
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Brief Pain Inventory-Modified Short Form (BPI-SF) Interference Score Between Responder and Non-Responder Participants at 4 Weeks
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change From Baseline HAMD-17 Total Score at 8 Weeks
timeFrame: Baseline, 8 weeks
measure: Change From Baseline HAMD-17 Core Subscale at 8 Weeks
timeFrame: Baseline, 8 weeks
measure: Change From Baseline HAMD-17 Maier Subscale at 8 Weeks
timeFrame: Baseline, 8 weeks
measure: Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks
timeFrame: Baseline, 8 weeks
measure: Change From Baseline HAMD-17 Retardation/Somatization Subscale at 8 Weeks
timeFrame: Baseline, 8 weeks
measure: Change From Baseline HAMD-17 Sleep Subscale at 8 Weeks
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in the Hamilton Anxiety Rating Scale (HAMA) at 8 Weeks
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in the Clinical Global Impression - Severity (CGI-Severity) Scale at 8 Weeks
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in the Brief Pain Inventory - Modified Short Form (BPI-SF) Average Pain Score at 8 Weeks
timeFrame: Baseline, 8 weeks
measure: Change From Baseline in Patient Global Impression - Improvement (PGI-I) Scale Score at 8 Weeks
timeFrame: 8 weeks
measure: Change From Baseline in the Sexual Functioning Questionnaire Clinical Version (CSFQ) at 4 and 8 Weeks
timeFrame: Baseline, 4 Weeks, 8 weeks
measure: Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM) at 4 and 8 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Change From Baseline in the Sheehan Disability Scale (SDS) at 4 and 8 Weeks
timeFrame: Baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Guri City
country: Korea, Republic of
facility: 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
country: Korea, Republic of
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: