Contact: Developing New Clinical Management Strategies
Status:
Completed
Trial end date:
2021-08-01
Target enrollment:
Participant gender:
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.