Lead Investigator: Mariam Khayretdinova, Brainify.ai
Title of Proposal Research: Predicting Placebo Response in Major Depressive Disorder on Clinical Trials Data Using Artificial Intelligence (AI)/Machine Learning (ML) on Clinical Data
Vivli Data Request: 10137
Funding Source: None
Potential Conflicts of Interest: None
Summary of the Proposed Research:
Depression is a multifaceted condition that impacts over 350 million individuals globally. Its diagnosis and treatment are challenging due to the heterogeneous nature of its manifestations, complicating the identification of effective therapeutic interventions. Notably, approximately 30% of individuals diagnosed with Major Depressive Disorder (MDD) exhibit treatment-resistant depression (TRD), emphasizing the necessity for treatments that are customized to the specific needs of each patient.
The placebo effect is a significant phenomenon in this context, wherein individuals experience symptomatic improvement following the administration of a treatment lacking active therapeutic ingredients, driven solely by the belief that they are receiving an actual treatment. This phenomenon underscores the powerful influence of psychological factors on health outcomes and presents a substantial challenge in clinical trials for novel antidepressants, as it can obscure the true efficacy of the investigational drug.
To address these challenges, researchers are increasingly utilizing clinical data to identify biomarkers predictive of this responses. By employing machine learning techniques to analyze clinical data, we aim to uncover patterns indicative of a patient’s potential response to placebo treatments. Identifying placebo responders can also help enhance the accuracy of effect size estimation for active interventions. When researchers can account for individuals who respond largely due to placebo mechanisms, the measured difference between the treatment and control groups becomes more precise. Consequently, effect sizes for genuinely effective medications are less likely to be diluted or confounded, leading to clearer insights into a drug’s true therapeutic valueю Ultimately, these findings enable more personalized treatment strategies, improving outcomes for individuals suffering from depression and other conditions.
Requested Studies:
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression
Data Contributor: Johnson & Johnson
Study ID: NCT02417064
Sponsor ID: CR107146
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects With Treatment-resistant Depression
Data Contributor: Johnson & Johnson
Study ID: NCT02418585
Sponsor ID: CR107147
A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects With Treatment-resistant Depression
Data Contributor: Johnson & Johnson
Study ID: NCT02422186
Sponsor ID: CR107129
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide
Data Contributor: Johnson & Johnson
Study ID: NCT03039192
Sponsor ID: CR108284
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intranasal Esketamine in Addition to Comprehensive Standard of Care for the Rapid Reduction of the Symptoms of Major Depressive Disorder, Including Suicidal Ideation, in Adult Subjects Assessed to be at Imminent Risk for Suicide
Data Contributor: Johnson & Johnson
Study ID: NCT03097133
Sponsor ID: CR108285
Duloxetine Versus Escitalopram and Placebo in the Treatment of Patients With Major Depression
Data Contributor: Lilly
Study ID: NCT00073411
Sponsor ID: 7978
Duloxetine Versus Placebo in the Prevention of Recurrence of Major Depressive Disorder
Data Contributor: Lilly
Study ID: NCT00105989
Sponsor ID: 8606
A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Lu AA21004 (15 and 20 mg/Day) in the Acute Treatment of Adult Patients With Major Depressive Disorder
Data Contributor: Lundbeck
Study ID: NCT01140906
Sponsor ID: 13267A
A Randomised, Double-blind, Parallel-group, Placebo-controlled, Duloxetine-referenced, Fixed-dose Study Evaluating the Efficacy and Safety of Three Dosages of [Vortioxetine] Lu AA21004, in Acute Treatment of Major Depressive Disorder
Data Contributor: Lundbeck
Study ID: NCT00635219
Sponsor ID: 11984A
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study To Evaluate The Efficacy And Safety Of 2 Fixed Doses (10 And 50 mg/Day) Of DVS SR Tablets In Adult Outpatients With Major Depressive Disorder
Data Contributor: Pfizer Inc.
Study ID: NCT00863798
Sponsor ID: 3151A1-3362
A Multicenter, Randomized, 8-week, Double-blind, Placebo-controlled Study Followed by a 6-month Open-label Extension to Evaluate the Efficacy and Safety of DVS SR in Peri- and Postmenopausal Women With Major Depressive Disorder
Data Contributor: Pfizer Inc.
Study ID: NCT00369343
Sponsor ID: 3151A1-403
A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Active-Referenced, Fixed-Dose Study Comparing the Efficacy and Safety of 2 Doses of Lu AA21004 in Acute Treatment of Adults With Major Depressive Disorder
Data Contributor: Takeda
Study ID: NCT00672620
Sponsor ID: LuAA21004_304