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Placebo Response in Major Depressive Disorder.








Placebo Response in Major Depressive Disorder.


Ariana Anderson


University of California, Los Angeles


Sponsored research to Dr. Anderson through Burroughs Wellcome Fund.


Dr. Anderson has received research support through Burroughs Wellcome Fund.


01 February 2018


Roughly 1 in 10 adults in the United States has depression, yet development of interventions is hindered by the placebo response. The placebo response, which is active both in patients taking a genuine and sham intervention, can overwhelm true drug-related changes and block the ability to distinguish between effective and ineffective treatments for depression.

Many factors are known to impact the placebo response experienced by a subject, including the length of the trial, the probability that a subject will receive a placebo intervention, and the mannerisms of a clinician which may lead to an expectation bias in the patient. Previously, research in schizophrenia found that the placebo response is predictable within a subject, and patients who experienced certain symptom domains (e.g. positive) were more likely to be placebo responders. Given that the placebo response may be systematic and predictable within schizophrenia, it similarly may be predictable within major depressive disorder (MDD).

Although the placebo response is known to permeate all clinical trials, the trajectory over time as well as the susceptibility of unique individuals is yet unknown. Here, we will assess the temporal patterns and power of the placebo response in Major Depressive Disorder using the Hamilton Rating Scale for Depression (HAM-D) and the Montgomery–Asberg Depression Rating Scale (MADRS). These patterns will be compared to changes seen in patients receiving an active mediation. Using time series analyses and machine learning predictive modelling, we will assess whether some individuals are disproportionately susceptible to being placebo responders. Moreover, we will assess at which point in the study placebo responders are identifiable. These findings will be communicated to the public in scientific publications.



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Depression

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Treatment of Major Depression

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Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 3, Clinical Study ID: F1J-MC-HMAT(A), Sponsor: Lilly" },{ "PostingID": 1953, "Title": "LILLY-F1J-MC-HMAT(B)", "Description": "Duloxetine Versus Placebo and Paroxetine in the Acute Treatment of Major Depression

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Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 3, Clinical Study ID: F1J-MC-HMAY(B), Sponsor: Lilly" },{ "PostingID": 2006, "Title": "LILLY-F1J-MC-HMBH(A)", "Description": "Duloxetine Once-Daily Dosing
Versus Placebo in the Acute Treatment of Major Depression

Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 3, Clinical Study ID: F1J-MC-HMBH(A), Sponsor: Lilly" },{ "PostingID": 2007, "Title": "LILLY-F1J-MC-HMBH(B)", "Description": "Duloxetine Once-Daily Dosing
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Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 3, Clinical Study ID: F1J-MC-HMBH(B), Sponsor: Lilly" },{ "PostingID": 2013, "Title": "LILLY-F1J-US-HMCR", "Description": "Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression

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Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 4, Clinical Study ID: F1J-US-HMGR, Sponsor: Lilly" },{ "PostingID": 3092, "Title": "LILLY-F1J-US-HMGU", "Description": "Duloxetine Versus Placebo in the Acute Treatment of Patients With Major Depressive Disorder and Associated Painful Physical Symptoms

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Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 4, Clinical Study ID: F1J-CR-HMGM, Sponsor: Lilly" },{ "PostingID": 3161, "Title": "GSK-NKD20006", "Description": "An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Fixed-Dose Study Comparing the Efficacy and Safety of GW597599B or Paroxetine to Placebo in Moderately to Severely Depressed Patients with Major Depressive Disorder

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Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 3, Clinical Study ID: F1J-US-HMCB , Sponsor: Lilly." },{ "PostingID": 4919, "Title": "GSK-29060/274", "Description": "A study to assess the effectiveness and tolerance of paroxetine by double-blind comparison with placebo

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Statistical Analysis Plan


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