Switching to Duloxetine in Patients With Depression (ARDENT)

Lilly

Status and phase: Completed; Phase 4

Conditions: Depressive Disorder, Major

Treatments: Drug: Duloxetine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00696774

12349

F1J-CR-S022 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

242 participants in 1 patient group

Duloxetine

Experimental group

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.

Treatment:

Drug: Duloxetine