A Study of Patients With Major Depressive Disorder and Residual Apathy
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: Duloxetine; Escitalopram
Intervention description: 60-120 milligrams (mg) taken once daily (QD) by mouth (po) for 8 weeks; with option for additional 2 weeks.; 10-20 mg taken QD po for 8 weeks; with option for additional 2 weeks.
Intervention MeSH terms: Duloxetine Hydrochloride; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 483.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Major Depressive Disorder; Apathy; Duloxetine Hydrochloride; SSRI; Escitalopram

Summary:

      The purpose of this study is to provide a comparison of the apathy, depression, and
      functional outcomes associated with switching to duloxetine or escitalopram in patients who
      have previously responded to treatment with a selective serotonin reuptake inhibitor (SSRI)
      for major depressive disorder and who have residual apathy in the absence of depressed mood.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Have received treatment with an SSRI (escitalopram, sertraline, paroxetine, or
             citalopram) for major depressive disorder

          -  Females of child-bearing potential to test negative for pregnancy at the time of
             enrollment based on a urine pregnancy test and agree to use a reliable method of birth
             control

          -  Apathy Evaluation Scale - Clinician Rated Version (AES-C) total score >30 at screening
             and randomization.

          -  Montgomery-Asberg Depression Rating Scale (MADRS) total score ≤15 and Item 1 (apparent
             sadness) score of <2 at screening and randomization.

          -  Have a level of understanding sufficient to provide informed consent and to
             communicate with the investigators, study coordinator, and site personnel.

        Exclusion Criteria:

          -  Are currently enrolled in, or discontinued within the last 30 days from, a clinical
             trial involving an off-label use of an investigational drug or device

          -  Have previously completed or withdrawn from this study or any other study
             investigating duloxetine.

          -  Have had previous lack of response to an adequate trial of duloxetine within the past
             12 months or escitalopram at any time.

          -  Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), diagnosis
             of mania, bipolar disorder, treatment resistant depression or psychosis; or current
             suicide risk

          -  Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text
             Revision(DSM-IV-TR),substance abuse or dependence within the 6 months

          -  Presence of an Axis II disorder

          -  Monoamine oxidase inhibitor (MAOI) treatment within 14 days prior to randomization or
             the potential need to use an MAOI during the study

          -  Positive urine drug screen for any substance of abuse or excluded medication.

          -  Are pregnant or breast-feeding.

          -  Serious medical illness, requires hospitalization during the study

          -  Have uncontrolled narrow-angle glaucoma.

          -  Have acute liver injury or severe cirrhosis

          -  Abnormal thyroid stimulating hormone (TSH) concentration

          -  Amphetamines, dopaminergic medications or modafinil within 14 days prior to
             randomization or potential need to use such medications during the study or within 14
             days of discontinuation of study drug.