Developing New Clinical Management Strategies
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      This study utilizes a 2 x 2, double-blind, acute, prospective design randomizing adult
      outpatients with MDD to "Research Frequency Management" (RFM, weekly study visits) vs.
      "Community Frequency Management" (CFM, every 4 weeks study visits) and antidepressant
      medication vs.placebo. Specifying visit frequency as the independent variable in this study
      has the distinct advantages of being easily operationalized for research purposes avoiding a
      priori assumptions about which components of study visits influence antidepressant and
      placebo response (i.e., behavioral activation vs. doctor-patient relationship vs. medical
      procedures). Close monitoring of all subjects will be assured by telephone evaluations of
      individuals randomized to CFM at intervals between monthly visits, and additional study
      contacts will be scheduled as necessary to maintain patient safety (all extra-protocol
      contacts will be recorded and included as a variable in outcome analyses). Additionally,
      subjects will be characterized extensively on clinical, demographic, and psychological
      measures to pilot the study assessment battery and search for predictor variables influencing
      the effects of contact frequency on medication and placebo response.
    

Intervention name(s): Escitalopram; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A substance or treatment of no intended therapeutic value in a pill form.
Other intervention name(s): Lexapro
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment