Early Versus Delayed Switch in Medication in Patients With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Duloxetine Hydrochloride; Escitalopram
Intervention description: Flexible dose of 60 or 120 mg daily; 10 mg in both Early and Delayed Intervention. Flexible dose of 10 to 20 mg daily in Delayed Intervention.
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 840.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; MDD; Depression

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.