Developing New Clinical Management Strategies
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Escitalopram; Placebo
Intervention description: A substance or treatment of no intended therapeutic value in a pill form.
Intervention MeSH terms: Escitalopram
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 3.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No

Summary:

      The goal of this study is to develop new methods of administering antidepressant medications
      that will result in improved drug/placebo separation in randomized controlled trials (RCTs)
      for Major Depressive Disorder (MDD) and enhanced medication response in open clinical
      treatment. The highly intensive, weekly visit schedule followed in most antidepressant RCTs
      radically differs from how antidepressant medications are prescribed in standard clinical
      practice and is believed to be a major reason why the majority of studies submitted to the
      Food and Drug Administration (FDA) fail to show a significant difference between medication
      and placebo. Moreover, a "one size fits all" approach to psychopharmacologic management
      (i.e., weekly visits for all patients) does not take into account differences between
      patients that may predispose some individuals to respond positively to frequent follow-up
      visits, while others may respond negatively or not at all. Clinic visits comprise multiple
      components that may be therapeutic for depression, including activating patients' behavior,
      exposing them to medical procedures, permitting social interactions with research staff, and
      providing supportive meetings with clinicians. Two independent meta-analyses have associated
      more frequent study visits with increased antidepressant and placebo response as well as
      decreased separation between medication and placebo. Despite the high costs and potential
      disadvantages of weekly follow-up visits for patients receiving antidepressant medication,
      this clinical management strategy has not been studied prospectively to date. It is unknown
      whether weekly follow-up visits are needed to ensure treatment compliance and patient safety
      in clinical trials and to what degree contacts with clinicians influence medication and
      placebo response.
    

Eligibility criteria:

        Inclusion Criteria:

          -  1. men and women aged 18-60 years

          -  2. diagnosis with Diagnostic and Statistical Manual (DSM) IV Major Depressive Disorder
             (MDD)

          -  3. 24-item Hamilton Rating Scale for Depression (HRSD) score greater than or equal to
             18

          -  4. capable of providing informed consent and complying with study procedures

          -  5. using appropriate contraceptive method if woman of child-bearing age

        Exclusion Criteria:

          -  1. Current comorbid Axis I DSM IV disorder other than Nicotine Dependence, Adjustment
             Disorder, or Anxiety Disorder

          -  2. diagnosis of substance abuse or dependence (excluding Nicotine Dependence) within
             the past 12 months

          -  3. present or past history of psychosis, psychotic disorder, mania, or bipolar
             disorder

          -  4. baseline HRSD score > 28 or HRSD suicide item > 2

          -  5. history of allergic or adverse reaction to escitalopram, or non-response to
             adequate trial of escitalopram (at least 4 weeks at dose of 20mg) during the current
             episode

          -  6. current treatment with psychotherapy, antidepressants, antipsychotics, or mood
             stabilizers

          -  7. CGI-Severity score of 7 at baseline

          -  8. acute, severe, or unstable medical illness