NCT01650740

Study of Placebo Without Deception Versus Standard Antidepressant for Major Depressive Disorder

A Randomized Trial of Sequenced Treatment Using Placebo Without Deception Followed by Open-Label Antidepressant Versus Immediate Open-Label Antidepressant Treatment for Major Depressive Disorder

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: Sunnybrook Health Sciences Centre · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	Duloxetine	30 mg daily x 1 week followed by 60 mg daily
DRUG	placebo	small placebo capsule (30 mg duloxetine equivalent) x 1 week followed by 60 mg equivalent capsule daily
OTHER	Study visits only	Weekly visits x 4 weeks followed by visits every 2 weeks

Timeline

• Start date: 2012-08-01
• Primary completion: 2014-08-01
• Completion: 2014-11-01
• First posted: 2012-07-26
• Last updated: 2014-12-23

Locations

1 site across 1 country: Canada