Antidepressant Response in the Treatment of Depressive Symptoms and Frailty Characteristics in Older Adults
Condition: Major Depressive Disorder; Dysthymic Disorder; Depressive Disorder, NOS
MeSH terms: Frailty; Depressive Disorder; Depression; Depressive Disorder, Major; Dysthymic Disorder
Intervention: Antidepressant Medication
Intervention description: If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant.
Intervention MeSH terms: Duloxetine Hydrochloride; Antidepressive Agents; Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 100.0
Sex: All
Minimum age: 60 Years
Maximum age: 95 Years
Healthy volunteers: No

Summary:

      The goal of this open-administration treatment study of citalopram (or duloxetine) is to
      evaluate the effect of antidepressant medication on treating the syndrome of "frailty" in
      older adults with depressive symptoms. Patients with significant depressive symptoms (defined
      as CES-D (Center for Epidemiological Studies - Depression scale) > 10) and 1 or more symptoms
      of the frailty syndrome (exhaustion, decreased energy, weight loss, decreased grip strength,
      and slow/unsteady gait) will be evaluated and treated with citalopram (or duloxetine) for 8
      weeks to test whether antidepressant medication improves both the syndrome of frailty and
      depressive symptoms. Patients evaluated at the Adult and Late Life Depression clinic and
      eligible to participate in the study will be treated with an antidepressant medication and
      assessed on the primary outcome variables (characteristics of frailty, depressive symptoms)
      as well as on secondary variables which include cognition (global cognition, episodic memory,
      executive function), and function (physical mobility, instrumental activities of daily
      living, and social functioning) prior to treatment initiation and following 8-weeks of
      treatment. The hypotheses for this protocol predict that we will discover a significant
      improvement on both frailty characteristics and depressive symptoms in this clinical
      population when treated with antidepressant medication (citalopram or duloxetine).
    

Eligibility criteria:

        Inclusion Criteria:

          -  Anyone with 1 or more characteristics of frailty

          -  HRSD>16 and a DSM-IV depressive disorder (e.g. MDD, Dysthymia)

          -  Capable of providing informed consent

          -  Currently followed by a PCP (had an eval in last 6-months)

        Exclusion Criteria:

          -  Acute cancer treatment

          -  Acute, severe or unstable medical illness

          -  End stage medical illness (e.g. liver, kidney, pulmonary)

          -  Mini Mental Exam < 24 or a diagnosis of dementia

          -  Individuals who do not have capacity to consent

          -  Diagnosis of substance abuse or dependence (last 12 months), excluding Nicotine
             dependence

          -  History of psychosis or psychotic disorder or bipolar disorder

          -  Patient is considered a significant risk of suicide

          -  Subject is considered based on history to be unlikely to respond to the single agent
             antidepressant (i.e., subjects with treatment resistant depression, including subjects
             with previous treatment with ECT)

          -  History of allergic or adverse reaction to escitalopram or duloxetine, or non-response
             to adequate trial of escitalopram (at least 4 weeks at dose of 20 mg) or duloxetine
             (at least 4 weeks at dose of 90mg).