Contact: Developing New Clinical Management Strategies
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Intervention: Escitalopram; Placebo
Intervention description: Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.; A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
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: 29.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 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:

        - Inclusion Criteria Method of Ascertainment

          1. Men and women aged 18-75 years 1. Clinical interview

          2. Diagnosis with Diagnostic and Statistical Manual (DSM) V Major Depressive Disorder
             (MDD) 2. Clinical interview, Structured Clinical Interview for DSM-V

          3. 24-item Hamilton Rating Scale for Depression (HRSD) score ≥ 16 and ≤ 28; 17-item
             Hamilton Rating Scale for Depression (HRSD) score < 25 3. HRSD by trained rater

          4. Capable of providing informed consent and complying with study procedures 4. Clinical
             interview

          5. Using appropriate contraceptive method if woman of child-bearing age and not currently
             pregnant 5. Clinical interview

        Exclusion Criteria:

          1. Current comorbid Axis I DSM V disorder other than Mild Substance Use Disorder,
             Adjustment Disorder, Anxiety Disorder or Personality Disorder 1. Clinical interview,
             SCID

          2. Diagnosis of Moderate to Severe Substance Use Disorder within the past 12 months 2.
             Clinical interview, SCID, Urine tox

          3. present or past history of psychosis, psychotic disorder, mania, or bipolar disorder
             3. Clinical interview, SCID

          4. baseline HRSD 24-item score > 28 or HRSD suicide item > 2 or baseline HRSD 17-item
             score ≥ 25 4. HRSD by trained rater

          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 5.
             Clinical interview

          6. Current treatment with psychotherapy, antidepressants, antipsychotics, or mood
             stabilizers 6. Clinical interview

          7. CGI-Severity score of 6 or greater at baseline 7. CGI based on Clinical interview

          8. Acute, severe, or unstable medical illness 8. Clinical interview, Physical Exam,
             Screening Labs