Back to resultsEarly Versus Delayed Switch in Medication in Patients With Major Depressive Disorder
Primary Purpose
Major Depressive Disorder
Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Duloxetine Hydrochloride
Escitalopram
Sponsored by
About this trial
This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, MDD, Depression
Eligibility Criteria
Inclusion Criteria
- Male or female participants of at least 18 years of age who meet criteria for Major Depressive Disorder (MDD), single or recurrent episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV®-TR) disease diagnostic criteria.
- Participants (receiving or not antidepressant treatment) who, based on investigator criteria, initiate treatment with escitalopram or change their current Alzheimer's Disease (AD) treatment to escitalopram for this current MDD episode, at the initial visit.
- Must have a baseline score of ≥ 19 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at the initial visit.
- Must have a baseline score of ≥ 4 in the Clinical Global Impression-Severity Scale (CGI-S) at the initial visit.
- Have a level of understanding sufficient to provide Informed Consent Document (ICD), and to communicate with the investigators and site personnel.
Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.
Exclusion Criteria:
- Have any current primary Axis I disorder other than MDD, including but not limited to dysthymia.
- Have a diagnosis of dementia, Alzheimer's disease (AD), or organic brain syndrome; or who are cognitively impaired or who have language problems that prevent them from understanding and/or providing valid answers to the rating scale contents.
- Concomitant participation in other studies with investigational or marketed products.
- Are not expected to be able to be monitored throughout the entire study period for reasons unrelated to their illness (for instance, change of residence or healthcare center of reference).
- Are demonstrating a response or demonstrated a response to the AD treatment for the current depression episode previous to baseline visit.
- Are investigator site personnel directly affiliated with this study and/or their immediate families. "Immediate family" is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Are employed by Lilly or Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or BI employees may participate in Lilly or BI-sponsored clinical trials, but are not permitted to participate at a Lilly or BI facility. "Immediate family" is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
- Women of childbearing potential who are not using a medically accepted means of contraception (for example, intrauterine device, oral contraceptive, contraceptive patch, implant, Depo-Provera [medroxyprogesterone acetate injectable suspension, Pharmacia & Upjohn], or barrier devices) when engaging in sexual intercourse. Women who are pregnant or breast-feeding may not participate in the study.
- Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
- Are judged to be at serious suicidal risk in the opinion of the investigator, and/or if the participant's baseline (Visit 1) HAMD-17 scores on item 3 suicide are 3.
- Have been treated with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1 or potential need to use an MAOI during the study or within 5 days after discontinuation of study drug.
- Require initiation or discontinuation of psychotherapy within 6 weeks prior to enrollment (Visit 1) or at any time during the study.
- Have any contraindication for the use of duloxetine based on Duloxetine Summary of Product Characteristics (SPC) or any contraindication for the use of escitalopram based on Escitalopram SPC.
- Have a history of lack of response to duloxetine or escitalopram at a clinically appropriate dose for a minimum of 4 weeks, or have previously completed or withdrawn from this study or any other study investigating duloxetine or escitalopram.
- Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
- Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
- Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
- Have had Electroconvulsive Therapy (ECT) or Transcranial Magnetic Stimulation within the past year.
Sites / Locations
- 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
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- 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
- 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
- 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
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early Intervention
Delayed Intervention
Arm Description
Escitalopram 10 milligrams per day for 4 weeks (one 10 milligram [mg]-capsule) followed by Duloxetine flexible dose (60 or 120 mg daily) for 12 weeks.
Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule) followed by Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule[s]). Then, non-responders switched to Duloxetine 60 or 120 mg per day for 8 weeks , and responders continued on Escitalopram 10 to 20 mg per day for 8 weeks.
Outcomes
Primary Outcome Measures
Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD 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).
Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response
Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as >=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD 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).
Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD 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).
Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission
Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD 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).
Secondary Outcome Measures
Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response. QIDS16SR is a 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission. A 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
Clinical Global Impressions of Severity (CGI-S) Scale
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 participants).
Visual Analog Scale (VAS) - Overall Pain Severity
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 10 centimeter (cm) line between two anchors (0= no pain and 10=very severe pain).
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
The EQ-5D Health State Score is self-rated health on a vertical, visual analogue scale measured in centimeters (cm) and reported as units on a scale. Best imaginable health state = 10 cm and worst imaginable health state = 0 cm.
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
The EQ-5D is a generic, multidimensional, health-related, quality of life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Sheehan Disability Scale (SDS) Normal Functioning Total Score
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
Resource Utilisation - Number of Hours Worked Per Week
Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks
Only those participants who missed at least 1 hour of work were included.
Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks
Only those participants who missed at least 1 hour of work due to depression were included.
Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks
Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks
Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response
Number of Participants With Adverse Events (AEs)
The list of AEs is located in the Reported Adverse Event module.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00810069
Brief Title
Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder
Official Title
Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
March 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study investigates two different approaches to the change in antidepressant treatment when an initial treatment is not effective: early intervention or delayed intervention.
Two hypothesis will be tested:
that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, MDD, Depression
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
840 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early Intervention
Arm Type
Experimental
Arm Description
Escitalopram 10 milligrams per day for 4 weeks (one 10 milligram [mg]-capsule) followed by Duloxetine flexible dose (60 or 120 mg daily) for 12 weeks.
Arm Title
Delayed Intervention
Arm Type
Experimental
Arm Description
Escitalopram 10 mg per day for 4 weeks (one 10 mg-capsule) followed by Escitalopram 10 to 20 mg per day for 4 weeks (one or two 10 mg capsule[s]). Then, non-responders switched to Duloxetine 60 or 120 mg per day for 8 weeks , and responders continued on Escitalopram 10 to 20 mg per day for 8 weeks.
Intervention Type
Drug
Intervention Name(s)
Duloxetine Hydrochloride
Other Intervention Name(s)
Cymbalta, LY248686
Intervention Description
Flexible dose of 60 or 120 mg daily
Intervention Type
Drug
Intervention Name(s)
Escitalopram
Other Intervention Name(s)
Lexapro, Cipralex
Intervention Description
10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.
Primary Outcome Measure Information:
Title
Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)
Description
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response defined as ≥ 50% baseline score reduction on the HAMD-17 for 2 consecutive visits. The 17-item HAMD 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).
Time Frame
Week 4 through Week 16
Title
Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response
Description
Survival function is estimating the probability of participants not achieving confirmed response after 12 weeks. Confirmed response is defined as >=50% change from baseline reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17). The 17-item HAMD 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).
Time Frame
Week 4 through Week 16
Title
Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits
Description
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission defined as a score on the HAMD-17 of ≤ 7 for 2 consecutive visits. The 17-item HAMD 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).
Time Frame
Week 4 through Week 16
Title
Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission
Description
Survival function is estimating the probability of participants not achieving confirmed remission. Confirmed remission is defined as a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 that is maintained for two consecutive visits. The 17-item HAMD 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).
Time Frame
Week 4 through Week 16
Secondary Outcome Measure Information:
Title
Time to Confirmed Response as Defined by ≥ 50% Reduction From Baseline Reduction in the 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) That is Reported for Two Consecutive Visits
Description
Time to confirmed response is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed response. QIDS16SR is a 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
Time Frame
Week 4 through Week 16
Title
Time to Confirmed Remission as Defined by a 16-Item Quick Inventory of Depressive Symptomatology Self Report (QIDS16SR) Score of ≤ 5 That is Maintained for Two Consecutive Visits.
Description
Time to confirmed remission is defined as the time from the day of study randomization (Visit 2) to the date of first observation of confirmed remission. A 16-item participant-rated measure of depressive symptomatology. The total score ranges from 0 to 27 with higher scores indicative of greater severity.
Time Frame
Week 4 through Week 16
Title
Clinical Global Impressions of Severity (CGI-S) Scale
Description
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 participants).
Time Frame
Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
Title
Visual Analog Scale (VAS) - Overall Pain Severity
Description
VAS for pain consists of 6 questions that assess overall pain, headache, back pain, shoulder pain, pain interference with daily activities, and pain while awake. Participant rates pain on a 10 centimeter (cm) line between two anchors (0= no pain and 10=very severe pain).
Time Frame
Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
Title
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
Description
The EQ-5D Health State Score is self-rated health on a vertical, visual analogue scale measured in centimeters (cm) and reported as units on a scale. Best imaginable health state = 10 cm and worst imaginable health state = 0 cm.
Time Frame
Baseline, Week 4, Week 8, Week 12, Week 16
Title
Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
Description
The EQ-5D is a generic, multidimensional, health-related, quality of life instrument. The profile allows participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and mood. A single score between 1 and 3 is generated for each domain. For each participant, the outcome rating on the 5 domains will be mapped to a single index through an algorithm. The index ranges between 0 and 1, with the higher score indicating a better health state perceived by the participant.
Time Frame
Baseline, Week 4, Week 8, Week 12, Week 16
Title
Sheehan Disability Scale (SDS) Normal Functioning Total Score
Description
The SDS is completed by the participant and is used to assess the effect of the participant's symptoms on their work/social/family life. Total scores range from 0 to 30 with higher values indicating greater disruption in the participant's work/social/family life.
Time Frame
Baseline, Week 4, Week 8, Week 12, Week 16
Title
Resource Utilisation - Number of Hours Worked Per Week
Time Frame
Baseline, Week 4, Week 8, Week 12, Week 16
Title
Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks
Description
Only those participants who missed at least 1 hour of work were included.
Time Frame
Week 4, Week 8, Week 12, Week 16
Title
Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks
Description
Only those participants who missed at least 1 hour of work due to depression were included.
Time Frame
Week 4, Week 8, Week 12, Week 16
Title
Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks
Time Frame
Week 4, Week 8, Week 12, Week 16
Title
Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks
Time Frame
Week 4, Week 8, Week 12, Week 16
Title
Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response
Time Frame
Week 4, Week 8, Week 12, Week 16
Title
Number of Participants With Adverse Events (AEs)
Description
The list of AEs is located in the Reported Adverse Event module.
Time Frame
Baseline through Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria
Male or female participants of at least 18 years of age who meet criteria for Major Depressive Disorder (MDD), single or recurrent episode according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV®-TR) disease diagnostic criteria.
Participants (receiving or not antidepressant treatment) who, based on investigator criteria, initiate treatment with escitalopram or change their current Alzheimer's Disease (AD) treatment to escitalopram for this current MDD episode, at the initial visit.
Must have a baseline score of ≥ 19 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at the initial visit.
Must have a baseline score of ≥ 4 in the Clinical Global Impression-Severity Scale (CGI-S) at the initial visit.
Have a level of understanding sufficient to provide Informed Consent Document (ICD), and to communicate with the investigators and site personnel.
Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.
Exclusion Criteria:
Have any current primary Axis I disorder other than MDD, including but not limited to dysthymia.
Have a diagnosis of dementia, Alzheimer's disease (AD), or organic brain syndrome; or who are cognitively impaired or who have language problems that prevent them from understanding and/or providing valid answers to the rating scale contents.
Concomitant participation in other studies with investigational or marketed products.
Are not expected to be able to be monitored throughout the entire study period for reasons unrelated to their illness (for instance, change of residence or healthcare center of reference).
Are demonstrating a response or demonstrated a response to the AD treatment for the current depression episode previous to baseline visit.
Are investigator site personnel directly affiliated with this study and/or their immediate families. "Immediate family" is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Are employed by Lilly or Boehringer Ingelheim (BI) (that is, employees, temporary contract workers, or designees responsible for the conduct of the study). Immediate family of Lilly or BI employees may participate in Lilly or BI-sponsored clinical trials, but are not permitted to participate at a Lilly or BI facility. "Immediate family" is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
Women of childbearing potential who are not using a medically accepted means of contraception (for example, intrauterine device, oral contraceptive, contraceptive patch, implant, Depo-Provera [medroxyprogesterone acetate injectable suspension, Pharmacia & Upjohn], or barrier devices) when engaging in sexual intercourse. Women who are pregnant or breast-feeding may not participate in the study.
Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry.
Are judged to be at serious suicidal risk in the opinion of the investigator, and/or if the participant's baseline (Visit 1) HAMD-17 scores on item 3 suicide are 3.
Have been treated with a monoamine oxidase inhibitor (MAOI) within 14 days prior to Visit 1 or potential need to use an MAOI during the study or within 5 days after discontinuation of study drug.
Require initiation or discontinuation of psychotherapy within 6 weeks prior to enrollment (Visit 1) or at any time during the study.
Have any contraindication for the use of duloxetine based on Duloxetine Summary of Product Characteristics (SPC) or any contraindication for the use of escitalopram based on Escitalopram SPC.
Have a history of lack of response to duloxetine or escitalopram at a clinically appropriate dose for a minimum of 4 weeks, or have previously completed or withdrawn from this study or any other study investigating duloxetine or escitalopram.
Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
Have serious or unstable cardiovascular, hepatic, renal, respiratory or hematological illness; symptomatic peripheral vascular disease; or other medical (including unstable hypertension and not clinically euthyroid) or psychological conditions that, in the opinion of the investigator, would compromise participation or be likely to require hospitalization during the course of the study.
Have had Electroconvulsive Therapy (ECT) or Transcranial Magnetic Stimulation within the past year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
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City
Copenhagen
ZIP/Postal Code
DK-2100
Country
Denmark
Facility Name
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City
Angouleme
ZIP/Postal Code
16000
Country
France
Facility Name
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City
Arcachon
ZIP/Postal Code
33120
Country
France
Facility Name
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City
Dole
ZIP/Postal Code
39100
Country
France
Facility Name
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City
Gujan Mestras
ZIP/Postal Code
33470
Country
France
Facility Name
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City
Marseille
ZIP/Postal Code
13385
Country
France
Facility Name
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City
Montpellier
ZIP/Postal Code
F-34295
Country
France
Facility Name
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City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
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City
Orvault
ZIP/Postal Code
44000
Country
France
Facility Name
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City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
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City
Athens
ZIP/Postal Code
10675
Country
Greece
Facility Name
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City
Haidari, Athens
ZIP/Postal Code
12462
Country
Greece
Facility Name
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City
Thessaloniki
ZIP/Postal Code
56429
Country
Greece
Facility Name
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City
Tripoli
ZIP/Postal Code
22100
Country
Greece
Facility Name
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City
Balassagyarmat
ZIP/Postal Code
2660
Country
Hungary
Facility Name
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City
Budapest
ZIP/Postal Code
1134
Country
Hungary
Facility Name
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City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
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City
Foggia
ZIP/Postal Code
71100
Country
Italy
Facility Name
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City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
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City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
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City
Parma
ZIP/Postal Code
43100
Country
Italy
Facility Name
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City
Pisa
ZIP/Postal Code
56100
Country
Italy
Facility Name
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City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
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City
Teramo
ZIP/Postal Code
64100
Country
Italy
Facility Name
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City
Terracina
ZIP/Postal Code
04019
Country
Italy
Facility Name
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City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
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City
Beek En Donk
ZIP/Postal Code
5741 CG
Country
Netherlands
Facility Name
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City
Brummen
ZIP/Postal Code
6971 AD
Country
Netherlands
Facility Name
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City
Brunssum
ZIP/Postal Code
6442 AG
Country
Netherlands
Facility Name
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City
Deurne
ZIP/Postal Code
5751 XJ
Country
Netherlands
Facility Name
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City
Heerde
ZIP/Postal Code
8181 TB
Country
Netherlands
Facility Name
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City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
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City
Constanta
Country
Romania
Facility Name
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City
Iasi
ZIP/Postal Code
700282
Country
Romania
Facility Name
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City
Timisoara
ZIP/Postal Code
300182
Country
Romania
Facility Name
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City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
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City
Alcala De Henares
ZIP/Postal Code
28806
Country
Spain
Facility Name
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City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
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City
Ferrol
ZIP/Postal Code
15405
Country
Spain
Facility Name
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City
Foios
ZIP/Postal Code
46134
Country
Spain
Facility Name
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City
Madrid
ZIP/Postal Code
28029
Country
Spain
Facility Name
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City
Palma De Mallorca
ZIP/Postal Code
07013
Country
Spain
Facility Name
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City
Salamanca
ZIP/Postal Code
37003
Country
Spain
Facility Name
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City
Sevilla
ZIP/Postal Code
41700
Country
Spain
Facility Name
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City
Vigo
ZIP/Postal Code
36205
Country
Spain
Facility Name
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City
Zamora
ZIP/Postal Code
49021
Country
Spain
Facility Name
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City
Zaragoza
ZIP/Postal Code
50002
Country
Spain
Facility Name
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City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Facility Name
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City
Halmstad
ZIP/Postal Code
302 32
Country
Sweden
Facility Name
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City
Lulea
ZIP/Postal Code
SE 972 35
Country
Sweden
Facility Name
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City
Lund
ZIP/Postal Code
223 61
Country
Sweden
Facility Name
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City
Malmo
ZIP/Postal Code
21135
Country
Sweden
Facility Name
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City
Stockholm
ZIP/Postal Code
11486
Country
Sweden
Facility Name
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City
Sundsvall
ZIP/Postal Code
SE-85231
Country
Sweden
Facility Name
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City
Ankara
ZIP/Postal Code
06000
Country
Turkey
Facility Name
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City
Antakya
ZIP/Postal Code
31040
Country
Turkey
Facility Name
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City
Capa
ZIP/Postal Code
34390
Country
Turkey
Facility Name
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City
Diskapi
ZIP/Postal Code
06110
Country
Turkey
Facility Name
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
Izmir
ZIP/Postal Code
35340
Country
Turkey
Facility Name
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
Sisli
ZIP/Postal Code
80220
Country
Turkey
12. IPD Sharing Statement
Citations:
PubMed Identifier
22722513
Citation
Romera I, Perez V, Menchon JM, Schacht A, Papen R, Neuhauser D, Abbar M, Svanborg P, Gilaberte I. Early switch strategy in patients with major depressive disorder: a double-blind, randomized study. J Clin Psychopharmacol. 2012 Aug;32(4):479-86. doi: 10.1097/JCP.0b013e31825d9958.
Results Reference
derived
Learn more about this trial
Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder
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