Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00810069
• Date of registration: 16/12/2008
• Prospective Registration: No
• Primary sponsor: Eli Lilly and Company
• Public title: Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder
• Scientific title: Comparison of Two Different Treatment Strategies in Patients With Major Depressive Disorder Not Exhibiting Improvement on Escitalopram Treatment: Early vs. Delayed Intervention Strategy
• Date of first enrolment: November 2008
• Target sample size: 840
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00810069
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

Denmark, France, Greece, Hungary, Italy, Netherlands, Romania, Slovenia, Spain, Sweden, Turkey

Contacts

• Name: Call 1-877-CTLILLY (1-877-285-4559) Mon-Fri 9AM-5PM Eastern time (UTC/GMT-5 hours, EST)
• Affiliation: Eli Lilly and Company

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Major Depressive Disorder

Intervention(s)

Drug: Escitalopram

Drug: Duloxetine Hydrochloride

Primary Outcome(s)

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]

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]

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]

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]

Secondary Outcome(s)

Euro Quality of Life Questionnaire-5 Dimensions (EQ-5D) Scale - Health State Score [Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16]

Resource Utilisation - Number of Work Hours Missed in the Last 4 Weeks [Time Frame: Week 4, Week 8, Week 12, Week 16]

Visual Analog Scale (VAS) - Overall Pain Severity [Time Frame: Baseline, Week 4, Week 6, Week 8, Week 10, Week 12, Week 14, Week 16]

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]

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]

Resource Utilisation - Number of Hours Worked Per Week [Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16]

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]

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]

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]

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]

Sheehan Disability Scale (SDS) Normal Functioning Total Score [Time Frame: Baseline, Week 4, Week 8, Week 12, Week 16]

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]

Number of Participants With Adverse Events (AEs) [Time Frame: Baseline through Week 16]

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]

Secondary ID(s)

12329

F1J-EW-HMGD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 21/06/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00810069