Study of Placebo Without Deception Versus Standard Antidepressant for Major Depressive Disorder
Status:
Terminated
Trial end date:
2014-11-01
Target enrollment:
Participant gender:
Summary
In recent years, there has been growing evidence that antidepressants are only marginally
effective compared to placebo for mild to moderate depression. In other words, although many
people improve when they take antidepressant medications, almost as many get better with
placebo pills. One possible solution to this problem would be to give patients a trail of a
placebo prior to giving them an antidepressant, however there are ethical issues with doing
this deceptively. New evidence from other placebo-responsive disorders such as irritable
bowel syndrome shows that people may benefit from placebos even if they know they are taking
them. This study aims to determine whether giving placebos without deception to people with
major depressive disorder followed by the option to switch to an antidepressant is an
effective strategy. There will be 3 groups of subjects. The first group is a standard
treatment arm and will receive duloxetine, an antidepressant. The second will be given a
placebo with the option to switch to duloxetine if they do not improve. The third group will
receive supportive clinical visits the option to switch to duloxetine if they do not improve.
This design will allow us to determine whether a sequenced treatment of a placebo without
deception and then the option to switch to an antidepressant is a viable strategy. It will
also help us to determine to what degree the benefit comes from the ritual of receiving and
taking the placebo tablet versus the benefit of visits with a doctor alone. The primary
hypothesis is that there will be a less than 5% difference between response rates after 12
weeks in the sequenced placebo-then-antidepressant treatment group (both subjects who have
remained on placebo as well as those who have switched to the antidepressant will be
considered as one group) compared to the immediate antidepressant therapy group.