drugset / Trial / NCT01919216
Placebo Effects in the Treatment of Depression: Cognitive and Neural Mechanisms
Phase 4
Completed
65 enrolled
New York State Psychiatric Institute
National Institute of Mental Health (NIMH) · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
Studies of the neural mechanisms underlying placebo effects in antidepressant clinical trials largely have been limited to demonstrating objective differences in brain activity between responders and non-responders to placebo. This 8 week Placebo-controlled and Open groups study employs a novel antidepressant trial design with integrated functional magnetic resonance imaging (fMRI) to manipulate patient expectancy and examine its neural mediators.
Timeline
- Start
- 2010-01
- Primary completion
- 2016-06
- Completion
- 2016-06
Publications
- Background Rutherford BR, Roose SP. A model of placebo response in antidepressant clinical trials. Am J Psychiatry. 2013 Jul;170(7):723-33. doi: 10.1176/appi.ajp.2012.12040474.
- Zilcha-Mano S, Wang Z, Peterson BS, Wall MM, Chen Y, Wager TD, Brown PJ, Roose SP, Rutherford BR. Neural mechanisms of expectancy-based placebo effects in antidepressant clinical trials. J Psychiatr Res. 2019 Sep;116:19-25. doi: 10.1016/j.jpsychires.2019.05.023. Epub 2019 May 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Citalopram | Small molecule | 20 mg | — |
| Comparator | Citalopram | Small molecule | 40 mg | — |