Clinical trial NCT00810069: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
MDD
Depression
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-12-17
Enrollment: 840
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: 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.


Eligibility criteria: 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.

   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.

Primary outcomes:
measure: Time to Confirmed Response by ≥ 50% Change From Baseline Reduction in the Hamilton Depression Rating Scale-17 Items (HAMD-17)
timeFrame: Week 4 through Week 16
measure: Estimated Probability of Not Reaching Confirmed Response at 12 Weeks Based on the Survival Function for the Time to Confirmed Response
timeFrame: Week 4 through Week 16
measure: Time to Confirmed Remission by a Hamilton Depression Rating Scale-17 Items (HAMD-17) Score of ≤ 7 That is Maintained for Two Consecutive Visits
timeFrame: Week 4 through Week 16
measure: Estimated Probability of Not Reaching Confirmed Remission at 12 Weeks Based on the Survival Function for the Time to Confirmed Remission
timeFrame: Week 4 through Week 16
Secondary outcomes:
measure: 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
timeFrame: Week 4 through Week 16
measure: 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.
timeFrame: Week 4 through Week 16
measure: Clinical Global Impressions of Severity (CGI-S) Scale
timeFrame: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
measure: Visual Analog Scale (VAS) - Overall Pain Severity
timeFrame: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16
measure: Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - United Kingdom (UK) Population Based Index Score
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Sheehan Disability Scale (SDS) Normal Functioning Total Score
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Resource Utilisation - Number of Hours Worked Per Week
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks
timeFrame: Week 4, Week 8, Week 12, Week 16
measure: Resource Utilisation - Number of Work Hours Missed Due to Depression in the Last 4 Weeks
timeFrame: Week 4, Week 8, Week 12, Week 16
measure: Resource Utilisation - Number of Visits to Primary Healthcare Provider Due to Depression in the Last 4 Weeks
timeFrame: Week 4, Week 8, Week 12, Week 16
measure: Resource Utilisation - Number of Visits to Other Specialists Due to Depression in the Last 4 Weeks
timeFrame: Week 4, Week 8, Week 12, Week 16
measure: Resource Utilisation - Has the Participant Been Hospitalized Due to Depression in the Last 4 Weeks - Number of Participants With a Yes Response
timeFrame: Week 4, Week 8, Week 12, Week 16
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Baseline through Week 16
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
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city: Dole
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city: Gujan Mestras
country: France
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city: Montpellier
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city: Nimes
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city: Orvault
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city: Tripoli
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city: Balassagyarmat
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city: Modena
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city: Parma
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city: Pisa
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city: Siena
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city: Teramo
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city: Terracina
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city: Torino
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city: Beek En Donk
country: Netherlands
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city: Brummen
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city: Brunssum
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city: Deurne
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city: Heerde
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city: Bucharest
country: Romania
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city: Constanta
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city: Iasi
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city: Timisoara
country: Romania
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city: Ljubljana
country: Slovenia
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city: Alcala De Henares
country: Spain
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city: Barcelona
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city: Ferrol
country: Spain
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city: Foios
country: Spain
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city: Madrid
country: Spain
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city: Palma De Mallorca
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city: Salamanca
country: Spain
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city: Sevilla
country: Spain
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city: Vigo
country: Spain
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city: Zamora
country: Spain
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city: Zaragoza
country: Spain
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city: Göteborg
country: Sweden
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city: Halmstad
country: Sweden
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city: Lulea
country: Sweden
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city: Lund
country: Sweden
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city: Malmo
country: Sweden
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city: Stockholm
country: Sweden
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city: Sundsvall
country: Sweden
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city: Ankara
country: Turkey
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city: Antakya
country: Turkey
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city: Capa
country: Turkey
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city: Diskapi
country: Turkey
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city: Izmir
country: Turkey
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city: Sisli
country: Turkey
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Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)
role: STUDY_DIRECTOR
References:
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.