Switching to Duloxetine in Patients With Depression

NCT00696774 | Completed Phase 4 Results

• 2 other identifiers: 12349F1J-CR-S022
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 2

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.

Conditions

Depressive Disorder, Major

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, 4 weeks

Secondary Outcomes (14)

• Percentage of Participants Meeting Criteria for Response on the 17-Item Hamilton Depression Rating Scale (HAMD-17) Maier Subscale at 4 and 8 Weeks

  Baseline, 4 weeks, 8 weeks

• Change From Baseline HAMD-17 Total Score at 8 Weeks

  Baseline, 8 weeks

• Change From Baseline HAMD-17 Core Subscale at 8 Weeks

  Baseline, 8 weeks

• Change From Baseline HAMD-17 Maier Subscale at 8 Weeks

  Baseline, 8 weeks

• Change From Baseline HAMD-17 Anxiety/Somatization Subscale at 8 Weeks

  Baseline, 8 weeks

Study Arms (1)

Duloxetine

EXPERIMENTAL

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

Interventions

Duloxetine DRUG

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.

Also known as: LY248686, Cymbalta

Duloxetine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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-si, 471-701, South Korea

Location

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, 136 705, South Korea

Location

Related Links

• Lilly Clinical Trial Registry

MeSH Terms

Conditions

Depressive Disorder, Major

Interventions

Duloxetine Hydrochloride

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 11, 2008
• First Posted: June 13, 2008
• Study Start: June 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: July 1, 2009
• Last Updated: September 8, 2010
• Results First Posted: August 11, 2010

Record last verified: 2010-09

Locations

KR (2)