Clinical trial NCT00105989: Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
Official title: Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder, Major
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2005-03-21
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the efficacy and safety of duloxetine compared with placebo in the prevention of depressive recurrences among patients with recurrent major depressive disorder.


Eligibility criteria: Inclusion Criteria:

* Patient must be at least 18 years old.
* Patient must be diagnosed with depression and have had previous episodes of depression.
* Patient must sign informed consent.

Exclusion Criteria:

* Female and pregnant or breastfeeding.
* History of bipolar disorder, schizophrenia, or other psychotic disorders.
* Suffer from a serious medical illness (other than depression) or abnormal laboratory result that would require a change in medication, intervention, or hospitalization.
* Have been treated with a medication called monoamine oxidase inhibitor (MAOI) within 14 days of the start of the study, or potential need to use a MAOI within 5 days of finishing the study.
* Have taken an antidepressant called fluoxetine within 30 days of the start of the study.

Primary outcomes:
measure: Percentage of Participants With Depressive Recurrence After Time (t) in Days
timeFrame: Every Visit from Week 34 up to Week 86 (Maintenance Phase)
Secondary outcomes:
measure: Recurrence Count
timeFrame: Every Visit from Week 35 up to Week 86 (Maintenance Phase)
measure: Percentage of Participants With Greater Than or Equal to 50% Worsening After Time (t) in Days
timeFrame: Every Visit from Week 34 up to Week 86 (Maintenance Phase)
measure: Loss of Response at Any Time
timeFrame: Every Visit from Week 35 up to Week 86 (Maintenance Phase)
measure: Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Acute and Continuation Phases
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Change From Baseline to Endpoint in 17-Item Hamilton Depression Rating Scale (HAMD-17) Total Score - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Acute and Continuation Phases
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Change From Baseline to Endpoint in Clinical Global Impressions (CGI) Severity Scale - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Acute and Continuation Phases
timeFrame: Week 10 (Acute) and Week 34 (Continuation)
measure: Mean Values at Endpoint in Patient's Global Impressions of Improvement (PGI-I) - Maintenance Phase
timeFrame: Week 86 (Maintenance Phase)
measure: Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Acute and Continuation Phases
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Change From Baseline to Endpoint in Hamilton Depression Rating Scale Subscales, Including the Core, Maier, Anxiety/Somatization, Retardation/Somatization, and Sleep Subscales, and the Depressed Mood Item - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Acute and Continuation Phase
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Change From Baseline to Endpoint in Visual Analog Scales (VAS) for Pain - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Acute and Continuation Phases
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Change From Baseline to Endpoint in Symptom Questionnaire-Somatic Subscale (SQ-SS) - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Acute and Continuation Phases
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Change From Baseline to Endpoint in Sheehan Disability Scale (SDS) - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Acute and Continuation Phase
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Change From Baseline to Endpoint in 36-item Short-Form Health Survey (SF-36) - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Acute and Continuation Phases
timeFrame: Week 0 through Week10 (Acute) through Week 34 (Continuation)
measure: Resource Utilization and Hospitalization Module - Visits to Health Care Providers - Maintenance Phase
timeFrame: Week 34 through Week 86 (Maintenance Phase)
measure: Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Acute and Continuation Phases
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Average Number of Hours Worked in a Week - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Acute and Continuation Phase
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Resource Utilization and Hospitalization Module - Change From Baseline to Endpoint in Number of Missed Paid Work Hours - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Males)
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Acute and Continuation Phases (Females)
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Males)
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Change From Baseline to Endpoint in Arizona Sexual Experience Scale (ASEX) - Maintenance Phase (Females)
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Vital Signs - Change From Baseline to Endpoint in Weight - Acute and Continuation Phases
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Vital Signs - Change From Baseline to Endpoint in Weight - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Vital Signs - Change From Baseline to Endpoint in Pulse - Acute and Continuation Phases
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Vital Signs - Change From Baseline to Endpoint in Pulse - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Acute and Continuation Phases
timeFrame: Week 0 and Week 10 (Acute) and Week 34 (Continuation)
measure: Vital Signs - Change From Baseline to Endpoint in Blood Pressure - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Chloride - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Eosinophils - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Platelet Count - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Sodium - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Uric Acid - Acute Phase
timeFrame: Week 0 and Week 10
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Albumin - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bicarbonate, HCO3 - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Direct - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Bilirubin, Total - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Erythrocyte Count - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Gamma-Glutamyl Transferase - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hematocrit - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Hemoglobin - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Leukocyte Count - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Low Density Lipoprotein (LDL) Cholesterol (Direct) - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Hemoglobin - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Mean Cell Volume (MCV) - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Monocytes - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Total Protein - Continuation Phase
timeFrame: Week 10 (baseline) and Week 34 (endpoint) (Continuation Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Alanine Aminotransferase (ALT) - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Calcium - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Statistically Significant Laboratory Measurements - Change From Baseline to Endpoint in Glucose - Maintenance Phase
timeFrame: Week 34 (baseline) and Week 86 (endpoint) (Maintenance Phase)
measure: Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of Participants -- Open-Label Acute Therapy Phase
timeFrame: Every Visit from Week 0 up to Week 10 (Acute)
measure: Treatment-Emergent Adverse Events Occurring in at Least 5 Percent of the Participants -- Open-Label Continuation Phase
timeFrame: Every Visit from Week 10 up to Week 34 (Continuation)
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Sherman Oaks
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: California
city: Baltimore
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Maryland
city: Gaithersburg
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: Maryland
city: Brooklyn
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
state: New York
city: Angouleme
country: France
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Douai
country: France
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Fains
country: France
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: La Rochelle
country: France
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lille
country: France
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Nimes
country: France
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Roubaix
country: France
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Strasbourg
country: France
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Berlin
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ellwangen
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Hamburg
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Hildesheim
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Leipzig
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Munchen
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Wurzburg
country: Germany
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Catania
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Ferrara
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Firenze
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Parma
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Roma
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Torino
country: Italy
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Moscow
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: St. Petersburg
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Village Nikolskoe
country: Russian Federation
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Halmstad
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Lund
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Malmo
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Stockholm
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
city: Sundsvall
country: Sweden
facility: For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri 9 AM - 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:
citation: Perahia DG, Maina G, Thase ME, Spann ME, Wang F, Walker DJ, Detke MJ. Duloxetine in the prevention of depressive recurrences: a randomized, double-blind, placebo-controlled trial. J Clin Psychiatry. 2009 May;70(5):706-16. doi: 10.4088/jcp.08m04756.