Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder
NCT ID: NCT00810069
Last Updated: 2011-06-21
Study Results
Results available
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View full resultsBasic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE4
Total Enrollment
840 participants
Study Classification
INTERVENTIONAL
Study Start Date
2008-11-30
Study Completion Date
2010-03-31
Brief Summary
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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:
1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
2. that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.
Two hypothesis will be tested:
1. that time to confirmed response is shorter in the early intervention strategy vs. delayed intervention strategy
2. that the time to confirmed remission is shorter in the early intervention strategy compared to delayed intervention strategy.
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Detailed Description
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Conditions
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Major Depressive Disorder
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Investigators
Study Groups
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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.
Group Type
EXPERIMENTAL
Duloxetine Hydrochloride
Intervention Type
DRUG
Flexible dose of 60 or 120 mg daily
Escitalopram
Intervention Type
DRUG
10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.
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.
Group Type
EXPERIMENTAL
Duloxetine Hydrochloride
Intervention Type
DRUG
Flexible dose of 60 or 120 mg daily
Escitalopram
Intervention Type
DRUG
10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.
Interventions
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Duloxetine Hydrochloride
Flexible dose of 60 or 120 mg daily
Intervention Type
DRUG
Escitalopram
10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.
Intervention Type
DRUG
Other Intervention Names
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Cymbalta
LY248686
Lexapro
Cipralex
Eligibility Criteria
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Inclusion Criteria
1. 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.
2. 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.
3. Must have a baseline score of ≥ 19 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at the initial visit.
4. Must have a baseline score of ≥ 4 in the Clinical Global Impression-Severity Scale (CGI-S) at the initial visit.
5. Have a level of understanding sufficient to provide Informed Consent Document (ICD), and to communicate with the investigators and site personnel.
6. Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.
2. 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.
3. Must have a baseline score of ≥ 19 on the 17-item Hamilton Depression Rating Scale (HAMD-17) at the initial visit.
4. Must have a baseline score of ≥ 4 in the Clinical Global Impression-Severity Scale (CGI-S) at the initial visit.
5. Have a level of understanding sufficient to provide Informed Consent Document (ICD), and to communicate with the investigators and site personnel.
6. Are judged to be reliable and agree to keep all appointments for clinic visits and procedures required by the protocol.
Exclusion Criteria
7. Have any current primary Axis I disorder other than MDD, including but not limited to dysthymia.
8. 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.
9. Concomitant participation in other studies with investigational or marketed products.
10. 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).
11. Are demonstrating a response or demonstrated a response to the AD treatment for the current depression episode previous to baseline visit.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. Require initiation or discontinuation of psychotherapy within 6 weeks prior to enrollment (Visit 1) or at any time during the study.
19. 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.
20. 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.
21. Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
22. Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
23. 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.
24. Have had Electroconvulsive Therapy (ECT) or Transcranial Magnetic Stimulation within the past year.
8. 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.
9. Concomitant participation in other studies with investigational or marketed products.
10. 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).
11. Are demonstrating a response or demonstrated a response to the AD treatment for the current depression episode previous to baseline visit.
12. 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.
13. 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.
14. 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.
15. 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.
16. 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.
17. 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.
18. Require initiation or discontinuation of psychotherapy within 6 weeks prior to enrollment (Visit 1) or at any time during the study.
19. 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.
20. 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.
21. Have any previous diagnosis of bipolar disorder, schizophrenia, or other psychotic disorders.
22. Have DSM-IV-defined history of substance abuse or dependence within the past year, excluding nicotine and caffeine.
23. 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.
24. Have had Electroconvulsive Therapy (ECT) or Transcranial Magnetic Stimulation within the past year.
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Sponsor Role
lead
Responsible Party
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Eli LIlly
Principal Investigators
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Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
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Copenhagen, , Denmark
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Angoulême, , France
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Arcachon, , France
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Alcalá de Henares, , Spain
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Ferrol, , Spain
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Palma de Mallorca, , Spain
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Salamanca, , Spain
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Seville, , Spain
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Vigo, , Spain
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Zaragoza, , Spain
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Gothenburg, , Sweden
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Halmstad, , Sweden
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Luleå, , Sweden
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Lund, , Sweden
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Malmo, , Sweden
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Stockholm, , Sweden
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Sundsvall, , Sweden
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Ankara, , Turkey (Türkiye)
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Dışkapı, , Turkey (Türkiye)
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Site Status
Countries
Review the countries where the study has at least one active or historical site.
Denmark
France
Greece
Hungary
Italy
Netherlands
Romania
Slovenia
Spain
Sweden
Turkey (Türkiye)
References
Explore related publications, articles, or registry entries linked to this study.
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.
Reference Type
DERIVED
Other Identifiers
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F1J-EW-HMGD
Identifier Type: OTHER
Identifier Source: secondary_id
12329
Identifier Type: -
Identifier Source: org_study_id
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