Exploratory analyses of efficacy data from major depressive disorder trials submitted to the US Food and Drug Administration in support of new drug applications.

No abstract is available for this paper.

• Publication year

  2011

• Venue

  Journal of Clinical Psychiatry

• Publication date

  2011-04-15

• Fields of study

  Medicine

• Identifiers
  DOI 10.4088/JCP.10m06191PMID 21527123
• External record

  Open on Semantic Scholar

• Source metadata

  Semantic Scholar, PubMed

• No claims are published for this paper.

• No concepts are published for this paper.

• Antidepressant drug effects and depression severity: a patient-level meta-analysis.

  2010cited by this paper
• Does the probability of receiving placebo influence clinical trial outcome? A meta-regression of double-blind, randomized clinical trials in MDD.

  2009cited by this paper
• Initial Severity and Antidepressant Benefits: A Meta-Analysis of Data Submitted to the Food and Drug Administration

  2008cited by this paper
• The Role of Ethnicity in Variability in Response to Drugs: Focus on Clinical Pharmacology Studies

  2008cited by this paper
• Is This the Drug or Dose for You?: Impact and Consideration of Ethnic Factors in Global Drug Development, Regulatory Review, and Clinical Practice

  2008cited by this paper
• Is bigger better for depression trials?

  2008cited by this paper
• Continental differences in clinical characteristics, management, and outcomes in patients hospitalized with worsening heart failure results from the EVEREST (Efficacy of Vasopressin Antagonism in Heart Failure: Outcome Study with Tolvaptan) program.

  2008cited by this paper
• An examination of the efficiency of the sequential parallel design in psychiatric clinical trials

  2007cited by this paper
• Why do clinical trials fail? The problem of measurement error in clinical trials: time to test new paradigms?

  2007cited by this paper
• Is it easier to find what you are looking for if you think you know what it looks like?

  2007cited by this paper
• An evaluation of the quick inventory of depressive symptomatology and the hamilton rating scale for depression: a sequenced treatment alternatives to relieve depression trial report.

  2006cited by this paper
• Severity of depressive symptoms and response to antidepressants and placebo in antidepressant trials.

  2005cited by this paper
• Research design features and patient characteristics associated with the outcome of antidepressant clinical trials.

  2004cited by this paper
• A comparison of face-to-face and videoconference administration of the Hamilton Depression Rating Scale

  2004cited by this paper
• Geographic variability in patient characteristics, treatment and outcome in an International Trial of Magnesium in acute myocardial infarction.

  2004cited by this paper
• Does elimination of placebo responders in a placebo run‐in increase the treatment effect in randomized clinical trials? A meta‐analytic evaluation

  2004cited by this paper
• Frequency of Positive Studies Among Fixed and Flexible Dose Antidepressant Clinical Trials: An Analysis of the Food and Drug Administraton Summary Basis of Approval Reports

  2003cited by this paper
• Placebo Response and Antidepressant Clinical Trial Outcome

  2003cited by this paper
• The Problem of the Placebo Response in Clinical Trials for Psychiatric Disorders: Culprits, Possible Remedies, and a Novel Study Design Approach

  2003cited by this paper
• Severity of Depression and Response to Antidepressants and Placebo: An Analysis of the Food and Drug Administration Database

  2002cited by this paper
• Are placebo controls necessary to test new antidepressants and anxiolytics?

  2002cited by this paper
• Relative sensitivity of the Montgomery-Asberg Depression Rating Scale, the Hamilton Depression rating scale and the Clinical Global Impressions rating scale in antidepressant clinical trials

  2002cited by this paper
• Placebo response in studies of major depression: variable, substantial, and growing.

  2002cited by this paper
• The Double-Blind Variable Placebo Lead-in Period: Results From Two Antidepressant Clinical Trials

  2001cited by this paper
• The scientific and ethical basis for placebo-controlled trials in depression and schizophrenia: an FDA perspective

  2001cited by this paper
• Effects of controlled-release metoprolol on total mortality, hospitalizations, and well-being in patients with heart failure: the Metoprolol CR/XL Randomized Intervention Trial in congestive heart failure (MERIT-HF). MERIT-HF Study Group.

  2000cited by this paper
• The Impact of Restrictive Entry Criterion During the Placebo Lead‐in Period

  2000cited by this paper
• Montgomery-Asberg severity gradations.

  1997cited by this paper
• Does a Placebo Run-In or a Placebo Treatment Cell Affect the Efficacy of Antidepressant Medications?

  1994cited by this paper
• Predictors of placebo response: a retrospective analysis.

  1992cited by this paper
• A Comparison of Depression Rating Scales

  1982cited by this paper
• A New Depression Scale Designed to be Sensitive to Change

  1979cited by this paper
• A RATING SCALE FOR DEPRESSION

  1960cited by this paper

• Placebo Effects in Modern Medicine: Mechanisms, Clinical Evidence, Limitations, and Future Directions

  2026cites this paper
• Synergistic antidepressant effects of Salvianolic acid B and Paeonol in CUMS-treated rats

  2026cites this paper
• [Efficacy and safety of super electroconvulsive therapy for treatment-resistant depression: a retrospective analysis of 292 cases].

  2026cites this paper
• Hope for Neurotic Disorders: A Summary of New Zealand Research on the Development of Biomarkers and Novel Treatments.

  2026cites this paper
• Comment on Esketamine Treatment for Depression in Adults: A PRISMA Systematic Review and Meta-Analysis.

  2025cites this paper
• The placebome.

  2025cites this paper
• Lumateperone monotherapy for major depressive episodes associated with bipolar disorder: efficacy and safety in a randomized placebo-controlled trial

  2025cites this paper
• Assessment of optimal combinations of therapeutic probiotics for depression, anxiety, and stress.

  2024cites this paper
• Acupuncture may play a key role in anti-depression through various mechanisms in depression

  2024cites this paper
• Antidepressants in the acute treatment of post-traumatic stress disorder in adults: a systematic review and meta-analysis

  2024cites this paper
• Extended-release ketamine tablets for treatment-resistant depression: a randomized placebo-controlled phase 2 trial

  2024cites this paper
• Effects of fish oil supplementation on bone turnover markers in depression: a pilot study

  2024cites this paper
• A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression.

  2024cites this paper
• Interpreting clinical trial outcomes complicated by placebo response with an assessment of false-negative and true-negative clinical trials in depression using propensity-weighting

  2023cites this paper
• Evidence versus expectancy: the development of psilocybin therapy

  2023cites this paper
• Clinical impacts of n-3 fatty acids supplementation on depression symptoms: an umbrella review of meta-analyses

  2023cites this paper
• Acupuncture Alleviates CUMS-Induced Depression-Like Behaviors by Restoring Prefrontal Cortex Neuroplasticity

  2023cites this paper
• A new method for analyzing clinical trials in depression based on individual propensity to respond to placebo estimated using artificial intelligence.

  2023cites this paper
• Irving Kirsch opens a window on antidepressant medications

  2023cites this paper
• The current state-of-the-art in pharmacotherapy for pediatric generalized anxiety disorder

  2023cites this paper
• Catalogue of bias: novelty bias

  2023cites this paper
• Efficacy and tolerability of zuranolone in patients with depression: a meta-analysis of randomized controlled trials

  2023cites this paper
• Efficacy and safety of zuranolone co-initiated with an antidepressant in adults with major depressive disorder: results from the phase 3 CORAL study

  2023cites this paper
• The effect and safety of probiotics on depression: a systematic review and meta-analysis of randomized controlled trials

  2023cites this paper
• Individual Deviations from Normative Electroencephalographic Connectivity Predict Antidepressant Response

  2023cites this paper
• Zuranolone in Major Depressive Disorder: Results From MOUNTAIN-A Phase 3, Multicenter, Double-Blind, Randomized, Placebo-Controlled Trial.

  2023cites this paper
• Central monitoring of depression and anxiety symptoms reduces placebo responses in depression clinical trials: A post hoc exploratory analysis of data from the phase III CCT‐004 trial of vortioxetine

  2022cites this paper
• Generalizability of treatment outcome prediction in major depressive disorder using structural MRI: A NeuroPharm study

  2022cites this paper
• The role of placebo response in the efficacy outcome assessment in viloxazine extended‐release pivotal trials in paediatric subjects with attention‐deficit/hyperactivity disorder

  2022cites this paper
• Assessing treatment benefit in the presence of placebo response using the sequential parallel comparison design

  2022influential citation
• Effectiveness of vortioxetine in patients with major depressive disorder comorbid with generalized anxiety disorder: Results of the RECONNECT study

  2022cites this paper
• Probiotics as an effective therapeutic approach in alleviating depression symptoms: an umbrella meta-analysis

  2022cites this paper
• Effect of AXS-05 (Dextromethorphan-Bupropion) in Major Depressive Disorder: A Randomized Double-Blind Controlled Trial.

  2022cites this paper
• Adjunctive Pimavanserin in Patients with Major Depressive Disorder: Combined Results from Two Randomized, Double-Blind, Placebo-Controlled Phase 3 Studies.

  2022cites this paper
• A new paradigm shift in antidepressant therapy? From dual-action to multitarget-directed ligands.

  2022cites this paper
• Doxycycline for the treatment of breast cancer-related lymphedema

  2022cites this paper
• Generalizability of Treatment Outcome Prediction in Major Depressive Disor‐ der Using Structural MRI: A NeuroPharm Study Using MRI: A

  2022cites this paper
• Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration

  2022cites this paper
• An exploratory machine learning approach to identify placebo responders in pharmacological binge eating disorder trials

  2022cites this paper
• Vitamin D protects against depression: Evidence from an umbrella meta-analysis on interventional and observational meta-analyses.

  2022cites this paper
• Systematic Review and Meta-Analysis of Vortioxetine for the Treatment of Major Depressive Disorder in Adults

  2022cites this paper
• Clinical, demographic, and genetic risk factors of treatment‐attributed suicidality in >10,000 Australian adults taking antidepressants

  2022cites this paper
• Using Artificial Intelligence-based Methods to Address the Placebo Response in Clinical Trials.

  2022cites this paper
• The Impact of Failed Antidepressant Trials on Outcomes in Children and Adolescents with Anxiety and Depression: A Systematic Review and Meta-Analysis

  2021cites this paper
• Efficacy and safety of fixed doses of intranasal Esketamine as an add-on therapy to Oral antidepressants in Japanese patients with treatment-resistant depression: a phase 2b randomized clinical study

  2021cites this paper
• Depression in the elderly and psychobiotics

  2021cites this paper
• Meta-Analysis: Pediatric Placebo Response in Depression Trials Does Not Replicate in Anxiety and Obsessive-Compulsive Disorder Trials.

  2021cites this paper
• Acupuncture Promoted the Recovery of the Neural Plasticity Functions and the Repair of Neural Plasticity-Related Proteins in the Prefrontal Cortex of CUMS-induced Depressed Rats

  2021cites this paper
• Antidepressant treatment effects and country income: meta‐regression analysis of individual participant data from duloxetine trials

  2021cites this paper
• The trouble with antidepressants: why the evidence overplays benefits and underplays risks—an essay by John B Warren

  2020cites this paper
• Raising Placebo Efficacy in Antidepressant Trials Across Decades Explained by Small-Study Effects: A Meta-Reanalysis

  2020cites this paper
• Comparative efficacy of placebos in short-term antidepressant trials for major depression: a secondary meta-analysis of placebo-controlled trials

  2020cites this paper
• A Growing Crisis in Schizophrenia Drug Development: Failing Signal Detection at North American and Other Clinical Trial Sites.

  2020cites this paper
• АНАМНЕСТИЧНІ КЛІНІКО-ПСИХОПАТОЛОГІЧНІ ОСОБЛИВОСТІ ДЕПРЕСИВНИХ ПРОЯВІВ У ПАЦІЄНТІВ ІЗ КОГНІТИВНИМИ ПОРУШЕННЯМИ ПРИ ДЕПРЕСИВНИХ РОЗЛАДАХ

  2020cites this paper
• Effective Treatment Interventions for Global Mental Health: An Analysis of Biomedical and Psychosocial Approaches in Use Today

  2020cites this paper
• John D. Loeser Award Lecture: Size does matter, but it isn't everything: the challenge of modest treatment effects in chronic pain clinical trials

  2020cites this paper
• Peculiarities of the perception process in patients with cognitive impairments in depressive disorders

  2020cites this paper
• Rate of Termination in Clinical Depression Trials

  2020cites this paper
• Randomized Controlled Trials and the Efficacy of Psychotropic Medications

  2019cites this paper
• Placebo response rate is ruining drug development in psychiatry: why is this happening and what can we do about it?

  2019cites this paper
• Notes on power comparison between the sequential parallel comparison and other commonly-used designs

  2019cites this paper
• Buprenorphine/samidorphan combination for the adjunctive treatment of major depressive disorder: results of a phase III clinical trial (FORWARD-3)

  2019cites this paper
• The rise and fall of MRI studies in major depressive disorder

  2019cites this paper
• Is High Placebo Response Really a Problem in Depression Trials? A Critical Re-analysis of Depression Studies.

  2019cites this paper
• No benefit from flexible titration above minimum licensed dose in prescribing antidepressants for major depression: systematic review

  2019cites this paper
• In Search of Psychiatric Kinds: Natural Kinds and Natural Classification in Psychiatry

  2019cites this paper
• Meta-Analysis of Placebo Response in Adult Antidepressant Trials

  2019cites this paper
• Clinical Role of Aspirin in Mood Disorders: A Systematic Review

  2019cites this paper
• Rising Placebo Response Rates Threaten the Validity of Antipsychotic Meta-Analyses

  2019cites this paper
• The antidepressant standoff: why it continues and how to resolve it

  2019cites this paper
• The Effects of Probiotics on Symptoms of Depression: Protocol for a Double-Blind Randomized Placebo-Controlled Trial

  2019cites this paper
• Early score fluctuation and placebo response in a study of major depressive disorder.

  2019cites this paper
• The Efficacy and Safety of Myelophil, an Ethanol Extract Mixture of Astragali Radix and Salviae Radix, for Chronic Fatigue Syndrome: A Randomized Clinical Trial

  2019cites this paper
• Comment on a Word to the Wise About Intranasal Esketamine.

  2019cites this paper
• Placebo Effect in the Treatment of Depression and Anxiety

  2019cites this paper
• The effects of a weight loss diet with or without prebiotic supplementation on anthropometric measures, metabolic and inflammatory status, gut permeability, endotoxemia and depression status in obese women suffering from major depressive disorder

  2019cites this paper
• Esketamine for Treatment-Resistant Depression - First FDA-Approved Antidepressant in a New Class.

  2019cites this paper
• A case study in identifying targeted patients population in major depressive disorder by enhanced enrichment design

  2018cites this paper
• Ambiguities in the Efficacy of Selective Serotonin Reuptake Inhibitors in the Treatment of Depression

  2018cites this paper
• Design considerations for handling dropouts in anti-depressant drug trials.

  2018cites this paper
• Against the stream: Antidepressants are not antidepressants – an alternative approach to drug action and implications for the use of antidepressants

  2018cites this paper
• Network meta-analysis of antidepressants.

  2018cites this paper
• Determinants of antidepressant response: Implications for practice and future clinical trials.

  2018cites this paper
• Opioid system modulation with buprenorphine/samidorphan combination for major depressive disorder: two randomized controlled studies

  2018cites this paper
• Personalized prediction of antidepressant v. placebo response: evidence from the EMBARC study

  2018influential citation
• Prophylactic SSRI treatment for women suffering from mood and anxiety symptoms undergoing in vitro fertilization—a prospective placebo-controlled study

  2018cites this paper
• Efficacy and tolerability of different doses of three new antidepressants for treating major depressive disorder: A PRISMA-compliant meta-analysis.

  2018cites this paper
• Vortioxetine: A new alternative for the treatment of major depressive disorder

  2018cites this paper
• The plan of enrichment designs for dealing with high placebo response

  2018cites this paper
• Placebo Effects Across Self-Report, Clinician Rating, and Objective Performance Tasks Among Women With Post-Traumatic Stress Disorder: Investigation of Placebo Response in a Pharmacological Treatment Study of Post-Traumatic Stress Disorder

  2018cites this paper
• A meta-analysis of the use of probiotics to alleviate depressive symptoms.

  2018cites this paper
• The conundrum of depression clinical trials: one size does not fit all

  2018cites this paper
• Impact of demographic factors on the antidepressant effect: A patient-level data analysis from depression trials submitted to the Pharmaceuticals and Medical Devices Agency in Japan.

  2018cites this paper
• Addressing High Placebo Response in Neuroscience Clinical Trials

  2018cites this paper
• Differences in the placebo response in duloxetine and venlafaxine trials

  2018cites this paper
• Factors associated with placebo response in depression trials: A systematic review of published meta-analyses (1990–2017)

  2018cites this paper
• Early treatment response affects signal detection in a placebo-controlled depression study

  2017cites this paper
• Dose equivalents for second generation long-acting injectable antipsychotics: The minimum effective dose method.

  2017cites this paper
• Safety, Science, or Both? Deceptive Healthy Volunteers: Psychiatric Conditions Uncovered by Objective Methods of Screening.

  2017cites this paper
• Aligning physiology with psychology: Translational neuroscience in neuropsychiatric drug discovery

  2017cites this paper