- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00810069
Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder
May 20, 2011 updated by: Eli Lilly and Company
Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
840
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Copenhagen, Denmark, DK-2100
- 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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Angouleme, France, 16000
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Arcachon, France, 33120
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Dole, France, 39100
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Gujan Mestras, France, 33470
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Marseille, France, 13385
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Montpellier, France, F-34295
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Nimes, France, 30029
- 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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Orvault, France, 44000
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Rennes, France, 35000
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Athens, Greece, 10675
- 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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Haidari, Athens, Greece, 12462
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Thessaloniki, Greece, 56429
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Tripoli, Greece, 22100
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Balassagyarmat, Hungary, 2660
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Budapest, Hungary, 1134
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Chieti, Italy, 66100
- 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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Foggia, Italy, 71100
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Milano, Italy, 20121
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Modena, Italy, 41100
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Parma, Italy, 43100
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Pisa, Italy, 56100
- 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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Siena, Italy, 53100
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Teramo, Italy, 64100
- 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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Terracina, Italy, 04019
- 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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Torino, Italy, 10126
- 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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Beek En Donk, Netherlands, 5741 CG
- 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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Brummen, Netherlands, 6971 AD
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Brunssum, Netherlands, 6442 AG
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Deurne, Netherlands, 5751 XJ
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Heerde, Netherlands, 8181 TB
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Bucharest, Romania, 020125
- 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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Constanta, Romania
- 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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Iasi, Romania, 700282
- 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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Timisoara, Romania, 300182
- 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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Ljubljana, Slovenia, 1000
- 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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Alcala De Henares, Spain, 28806
- 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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Barcelona, Spain, 08025
- 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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Ferrol, Spain, 15405
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Foios, Spain, 46134
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Madrid, Spain, 28029
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Palma De Mallorca, Spain, 07013
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Salamanca, Spain, 37003
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Sevilla, Spain, 41700
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Vigo, Spain, 36205
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Zamora, Spain, 49021
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Zaragoza, Spain, 50002
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Göteborg, Sweden, 41345
- 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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Halmstad, Sweden, 302 32
- 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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Lulea, Sweden, SE 972 35
- 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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Lund, Sweden, 223 61
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Malmo, Sweden, 21135
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Stockholm, Sweden, 11486
- 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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Sundsvall, Sweden, SE-85231
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Ankara, Turkey, 06000
- 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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Antakya, Turkey, 31040
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Capa, Turkey, 34390
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Diskapi, Turkey, 06110
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Izmir, Turkey, 35340
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Sisli, Turkey, 80220
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Early Intervention
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.
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Flexible dose of 60 or 120 mg daily
Other Names:
10 mg in both Early and Delayed Intervention.
Flexible dose of 10 to 20 mg daily in Delayed Intervention.
Other Names:
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Experimental: Delayed Intervention
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.
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Flexible dose of 60 or 120 mg daily
Other Names:
10 mg in both Early and Delayed Intervention.
Flexible dose of 10 to 20 mg daily in Delayed Intervention.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)
Time Frame: Week 4 through Week 16
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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).
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Week 4 through Week 16
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Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response
Time Frame: Week 4 through Week 16
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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).
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Week 4 through Week 16
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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 Frame: Week 4 through Week 16
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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).
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Week 4 through Week 16
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Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission
Time Frame: Week 4 through Week 16
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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).
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Week 4 through Week 16
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 Frame: Week 4 through Week 16
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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.
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Week 4 through Week 16
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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 Frame: Week 4 through Week 16
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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.
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Week 4 through Week 16
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Clinical Global Impressions of Severity (CGI-S) Scale
Time Frame: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
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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).
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Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
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Visual Analog Scale (VAS) - Overall Pain Severity
Time Frame: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
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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).
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Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
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Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
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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.
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Baseline, Week 4, Week 8, Week 12, Week 16
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Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
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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.
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Baseline, Week 4, Week 8, Week 12, Week 16
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Sheehan Disability Scale (SDS) Normal Functioning Total Score
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
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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.
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Baseline, Week 4, Week 8, Week 12, Week 16
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Resource Utilisation - Number of Hours Worked Per Week
Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16
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Baseline, Week 4, Week 8, Week 12, Week 16
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Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks
Time Frame: Week 4, Week 8, Week 12, Week 16
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Only those participants who missed at least 1 hour of work were included.
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Week 4, Week 8, Week 12, Week 16
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Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks
Time Frame: Week 4, Week 8, Week 12, Week 16
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Only those participants who missed at least 1 hour of work due to depression were included.
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Week 4, Week 8, Week 12, Week 16
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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
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Week 4, Week 8, Week 12, Week 16
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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
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Week 4, Week 8, Week 12, Week 16
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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
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Week 4, Week 8, Week 12, Week 16
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Number of Participants With Adverse Events (AEs)
Time Frame: Baseline through Week 16
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The list of AEs is located in the Reported Adverse Event module.
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Baseline through Week 16
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST), Eli Lilly and Company
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
February 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
December 16, 2008
First Submitted That Met QC Criteria
December 16, 2008
First Posted (Estimate)
December 17, 2008
Study Record Updates
Last Update Posted (Estimate)
June 21, 2011
Last Update Submitted That Met QC Criteria
May 20, 2011
Last Verified
May 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Pathologic Processes
- Mood Disorders
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Psychotropic Drugs
- Serotonin Uptake Inhibitors
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Serotonin Agents
- Antidepressive Agents
- Dopamine Agents
- Antidepressive Agents, Second-Generation
- Serotonin and Noradrenaline Reuptake Inhibitors
- Duloxetine Hydrochloride
- Citalopram
Other Study ID Numbers
- 12329
- F1J-EW-HMGD (Other Identifier: Eli Lilly and Company)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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