Neurobiological Underpinnings of Placebo Response in Depression
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|ClinicalTrials.gov Identifier: NCT02562430|
Recruitment Status : Recruiting
First Posted : September 29, 2015
Last Update Posted : December 16, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depression||Drug: Welbutrin XL Drug: Placebo||Phase 4|
The objective of this pilot study is to investigate possible dopaminergic mechanisms underlying the placebo response in MDD.
We expect that mesolimbic DA mechanisms implicated in reward anticipation, reinforcement learning, and expectation play a critical role in mediating placebo responses in MDD. A better understanding of the neurobiological basis of placebo has enormous potential on different levels. On a clinical level, the understanding of placebo mechanisms could lead to a number of applications for therapeutic purposes, such as developing drugs that could enhance the effects of a therapeutic relationship or accelerate the onset of action of an antidepressant by manipulating the placebo-related mechanisms, even if the patient is hopeless or severely anhedonic. On a level of clinical trial innovation, if we confirm the role of dopamine in placebo response and we comprehend how the placebo response mechanistically takes place, this could lead to developing new drugs that could block the placebo effects in clinical trial participants and greatly decrease if not eliminate the placebo effect nested even in those subject who are drug responders, therefore increasing the effect size and decreasing the sample size of studies. Moreover if we can identify biosignatures of placebo effect and use them to predict response, we could potentially enrich samples with subjects who are less likely to be placebo responders and again this would result in increased signal detection in a clinical trial. Finally, with this initial study we plan to lay the foundation for other studies to investigate how this dopaminergic circuitry is affected by other treatments, such as psychotherapy, and what are the changes that are similar or different between antidepressants, placebo and specific forms of psychotherapy, transcranial magnetic stimulation, electroconvulsive therapy or deep brain stimulation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Neurobiological Underpinnings of Placebo Response in Depression|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2020|
Experimental: Active Treatment
12.5 % will be randomized to Welbutrin XL in phase 1 of the study.
Drug: Welbutrin XL
12.5% of participants will receive Welbutrin XL in phase 1 of the study.
Other Name: Buproprion XL
Active Comparator: Placebo Group
87.5% will be randomized to receive placebo in phase 1 of the study.
87.5% of subjects will be randomized to placebo in phase 1 of the study.
Other Name: Sugar pill
- HAM-D 32 [ Time Frame: 8 weeks ]
- Clinical Global Impressions [ Time Frame: 8 weeks ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02562430
|Contact: Cristina Cusin, MDfirstname.lastname@example.org|
|United States, Massachusetts|
|Depression Clinical and Research Program at Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|Contact: Cristina Cusin, MD|
|Principal Investigator:||Cristina Cusin, MD||Massachusetts General Hospital|