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Placebo Response in Major Depressive Disorder.
Proposal
1654
Title of Proposed Research
Placebo Response in Major Depressive Disorder.
Lead Researcher
Ariana Anderson
Affiliation
University of California, Los Angeles
Funding Source
Sponsored research to Dr. Anderson through Burroughs Wellcome Fund.
Potential Conflicts of Interest
Dr. Anderson has received research support through Burroughs Wellcome Fund.
Data Sharing Agreement Date
01 February 2018
Lay Summary
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.
Study Data Provided
[{ "PostingID": 1623, "Title": "GSK-MY-1043/BRL-029060/115", "Description": "A multicenter, randomized, double-blind, placebo-controlled comparison of paroxetine and fluoxetine in the treatment of major depressive disorder.
Medicine: paroxetine, Condition: Depressive Disorder, Major, Phase: 3, Clinical Study ID: MY-1043/BRL-029060/115, Sponsor: GSK" },{ "PostingID": 1633, "Title": "GSK-29060/448", "Description": "A Double-Blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Immediate Release Paroxetine and Modified Release Paroxetine in the Treatment of Major Depression
Medicine: paroxetine, Condition: Depressive Disorder, Major, Phase: 3, Clinical Study ID: 29060/448, Sponsor: GSK" },{ "PostingID": 1634, "Title": "GSK-29060/449", "Description": "A Double-Blind, Placebo Controlled Trial to Evaluate the Clinical Effects of Immediate Release Paroxetine and Modified Release Paroxetine in the Treatment of Major Depression
Medicine: paroxetine, Condition: Depressive Disorder, Major, Phase: 3, Clinical Study ID: 29060/449, Sponsor: GSK" },{ "PostingID": 1638, "Title": "GSK-29060/810", "Description": "A double-blind, placebo-controlled, 3-arm, fixed-dose study of 12.5 mg/day and 25mg/day Paroxetine CR in the treatment of Major Depression.
Medicine: paroxetine, Condition: Depressive Disorder, Major, Phase: 4, Clinical Study ID: 29060/810, Sponsor: GSK" },{ "PostingID": 1639, "Title": "GSK-29060/874", "Description": "Assessment of Paxil CR, 12.5 and 25 mg/day in treating elderly patients with major depression
Medicine: paroxetine, Condition: Depressive Disorder, Major, Phase: 3, Clinical Study ID: 29060/874, Sponsor: GSK" },{ "PostingID": 1646, "Title": "LILLY-F1J-MC-HMBC", "Description": "Duloxetine Versus Placebo in the Prevention of Relapse of Major Depressive Disorder
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 3, Clinical Study ID: F1J-MC-HMBC, Sponsor: Lilly" },{ "PostingID": 1649, "Title": "LILLY-F1J-US-HMFA", "Description": "Duloxetine Versus Placebo in the Long-Term Treatment of Patients With Late-Life Major Depression
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 4, Clinical Study ID: F1J-US-HMFA, Sponsor: Lilly" },{ "PostingID": 1949, "Title": "LILLY-F1J-MC-HMAI", "Description": "A Double-Blind, Placebo- and Clomipramine-Controlled Study of Duloxetine in Patients with Major
Depression
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 2, Clinical Study ID: F1J-MC-HMAI, Sponsor: Lilly" },{ "PostingID": 1950, "Title": "LILLY-F1J-MC-HMAQ(A)", "Description": "Duloxetine Versus Placebo in the
Treatment of Major Depression
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 2, Clinical Study ID: F1J-MC-HMAQ(A), Sponsor: Lilly" },{ "PostingID": 1951, "Title": "LILLY-F1J-MC-HMAQ(B)", "Description": "Duloxetine Versus Placebo in the
Treatment of Major Depression
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 2, Clinical Study ID: F1J-MC-HMAQ(B), Sponsor: Lilly" },{ "PostingID": 1952, "Title": "LILLY-F1J-MC-HMAT(A)", "Description": "Duloxetine Versus Placebo and Paroxetine in the Acute Treatment of Major Depression
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
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 3, Clinical Study ID: F1J-MC-HMAT(B), Sponsor: Lilly" },{ "PostingID": 1955, "Title": "LILLY-F1J-MC-HMDI", "Description": "Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 3, Clinical Study ID: F1J-MC-HMDI, Sponsor: Lilly" },{ "PostingID": 1956, "Title": "LILLY-F1J-US-HMFS", "Description": "Duloxetine Versus Placebo in Patients With Major Depressive Disorder (MDD): Assessment of Energy and Vitality in MDD
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 4, Clinical Study ID: F1J-US-HMFS, Sponsor: Lilly" },{ "PostingID": 1982, "Title": "GSK-NKF100096", "Description": "A Randomised, Double-Blind, Double-Dummy, Parallel-Group, Placebo-Controlled, Forced Dose Titration Study Evaluating the Efficacy and Safety of GW679769 and Paroxetine in Subjects with Major depressive Disorder (MDD)
Medicine: casopitant, Condition: Depressive Disorder, Major, Phase: 2, Clinical Study ID: NKF100096, Sponsor: GSK" },{ "PostingID": 2004, "Title": "LILLY-F1J-MC-HMAY(A)", "Description": "Duloxetine Versus Placebo and Paroxetine in the Treatment of Major Depression
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 3, Clinical Study ID: F1J-MC-HMAY(A), Sponsor: Lilly" },{ "PostingID": 2005, "Title": "LILLY-F1J-MC-HMAY(B)", "Description": "Duloxetine Versus Placebo and Paroxetine in the Treatment of Major Depression
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
Versus Placebo in the Acute Treatment of Major Depression
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
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 3, Clinical Study ID: F1J-US-HMCR, Sponsor: Lilly" },{ "PostingID": 2086, "Title": "LILLY-F1J-MC-HMAH", "Description": "Duloxetine 20/30 mg vs. Placebo in Major Depression
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 2, Clinical Study ID: F1J-MC-HMAH, Sponsor: Lilly" },{ "PostingID": 2125, "Title": "GSK-29060/07/001", "Description": "A Double-Blind Comparison of Paroxetine, Amitriptyline, and Placebo in Inpatients with Major Depressive Disorder with Melancholia
Medicine: paroxetine, Condition: Depressive Disorder, Major, Phase: 2, Clinical Study ID: 29060/07/001, Sponsor: GSK" },{ "PostingID": 2132, "Title": "GSK-26090/007", "Description": "A Double-Blind Placebo Controlled Study to Compare Paroxetine with Maprotiline in the Treatment of Depression
Medicine: paroxetine, Condition: Depressive Disorder, Phase: 3, Clinical Study ID: 26090/007, Sponsor: GSK" },{ "PostingID": 2133, "Title": "GSK-29060/276", "Description": "A double-blind study to investigate the efficacy, safety and tolerability of Paroxetine in the treatment of depression in comparison with placebo
Medicine: paroxetine, Condition: Depressive Disorder, Phase: 2, Clinical Study ID: 29060/276, Sponsor: GSK" },{ "PostingID": 3090, "Title": "LILLY-F1J-US-HMGR", "Description": "A Phase 4, 8-week, Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy of Duloxetine 60 mg Once Daily in Outpatients with Major Depressive Disorder and Associated Painful Physical Symptoms
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
Medicine: Duloxetine hydrochloride, Condition: Major Depressive Disorder, Phase: 4, Clinical Study ID: F1J-US-HMGU, Sponsor: Lilly" },{ "PostingID": 3093, "Title": "LILLY-F1J-CR-HMGM", "Description": "A Phase 4, 8-week, Double-blind, Randomized Study Comparing Switching to Duloxetine or Escitalopram in Patients With Major Depressive Disorder and Residual Apathy in the Absence of Depressed Mood
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
Medicine: vestipitant, Condition: Depressive Disorder, Major, Phase: 2, Clinical Study ID: NKD20006, Sponsor: GSK" },{ "PostingID": 3563, "Title": "GSK-HTP109035", "Description": "A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of GSK163090 in Subjects with Major Depressive Disorder
Medicine: GSK163090, Condition: Depressive Disorder, Major, Phase: 2, Clinical Study ID: HTP109035, Sponsor: GSK" },{ "PostingID": 4628, "Title": "LILLY-F1J-US-HMCB", "Description": "Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain
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
Medicine: paroxetine, Condition: Depressive Disorder, Major, Phase: 3, Clinical Study ID: 29060/274, Sponsor: GSK" }]
Statistical Analysis Plan
The statistical analysis plan will be added after the research is published.
Publication Citation
The publication citation will be added after the research is published.
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