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Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study

American Journal of Psychiatry, 2018-07, Vol.175 (7), p.620-630

2018

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Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study

Schizophrenia research, 2007-07, Vol.93 (1), p.117-130

2007

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Efficacy and Safety of Paliperidone Extended-Release Tablets: Results of a 6-Week, Randomized, Placebo-Controlled Study

Biological psychiatry (1969), 2007-12, Vol.62 (12), p.1363-1370

2007

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A Controlled, Evidence-Based Trial of Paliperidone Palmitate, A Long-Acting Injectable Antipsychotic, in Schizophrenia

Neuropsychopharmacology (New York, N.Y.), 2010-09, Vol.35 (10), p.2072-2082

2010

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Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia

Progress in neuro-psychopharmacology & biological psychiatry, 2009-08, Vol.33 (6), p.1022-1031

2009

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Paliperidone extended-release as adjunctive therapy to lithium or valproate in the treatment of acute mania: A randomized, placebo-controlled study

Journal of affective disorders, 2011-03, Vol.129 (1), p.252-260

2011

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A randomized, placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder

Bipolar disorders, 2010-05, Vol.12 (3), p.230-243

2010

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Efficacy and safety of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 52-week open-label studies

International clinical psychopharmacology, 2008-11, Vol.23 (6), p.343-356

2008

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Safety and Tolerability of Oral Paliperidone Extended-Release Tablets in Elderly Patients With Schizophrenia: A Double-Blind, Placebo-Controlled Study With Six-Month Open-Label Extension

The American journal of geriatric psychiatry, 2008, Vol.16 (1), p.31-43

2008

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On clinical trials with a high placebo response rate

Contemporary clinical trials communications, 2016-04, Vol.2 (C), p.34-53

2016

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Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study

The American journal of psychiatry, 2019-06, Vol.176 (6), p.428-438

2019

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Esketamine Nasal Spray for Rapid Reduction of Major Depressive Disorder Symptoms in Patients Who Have Active Suicidal Ideation With Intent: Double-Blind, Randomized Study (ASPIRE I)

The journal of clinical psychiatry, 2020-05, Vol.81 (3)

2020

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Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression—TRANSFORM-3

The American journal of geriatric psychiatry, 2020-02, Vol.28 (2), p.121-141

2020

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Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression: A Randomized Clinical Trial

JAMA psychiatry (Chicago, Ill.), 2018-02, Vol.75 (2), p.139

2018

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Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial

JAMA psychiatry (Chicago, Ill.), 2019-09, Vol.76 (9), p.893

2019

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Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II)

The international journal of neuropsychopharmacology, 2021-01, Vol.24 (1), p.22-31

2021

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Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

JAMA : the journal of the American Medical Association, 2017-12, Vol.318 (23), p.2337

2017

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Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1)

The international journal of neuropsychopharmacology, 2019-10, Vol.22 (10), p.616-630

2019

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A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression

The American journal of psychiatry, 2016-08, Vol.173 (8), p.816-826

2016

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Sample size increase during a survival trial when interim results are promising

Communications in statistics. Theory and methods, 2017-07, Vol.46 (14), p.6846-6863

2017

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Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled study

Schizophrenia research, 2010-02, Vol.116 (2), p.107-117

2010

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Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2)

The journal of clinical psychiatry, 2020-04, Vol.81 (3)

2020

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Assessing treatment benefit in the presence of placebo response using the sequential parallel comparison design

Statistics in medicine, 2022-05, Vol.41 (12), p.2166-2190

2022

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A Phase 2/3 Placebo-Controlled, Parallel Group, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy: the ARISE study (P14-8.006)

Neurology, 2023-04, Vol.100 (17_supplement_2)

2023

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A randomized, placebo- and active-controlled study of paliperidone extended-release as maintenance treatment in patients with bipolar I disorder after an acute manic or mixed episode

Journal of affective disorders, 2012-05, Vol.138 (3), p.247-258

2012

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Efficacy and Safety of Intranasal Esketamine for the Rapid Reduction of Symptoms of Depression and Suicidality in Patients at Imminent Risk for Suicide: Results of a Double-Blind, Randomized, Placebo-Controlled Study

Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): Results of a 6-week, randomized, placebo-controlled study

Efficacy and Safety of Paliperidone Extended-Release Tablets: Results of a 6-Week, Randomized, Placebo-Controlled Study

A Controlled, Evidence-Based Trial of Paliperidone Palmitate, A Long-Acting Injectable Antipsychotic, in Schizophrenia

Safety and tolerability of deltoid and gluteal injections of paliperidone palmitate in schizophrenia

Paliperidone extended-release as adjunctive therapy to lithium or valproate in the treatment of acute mania: A randomized, placebo-controlled study

A randomized, placebo- and active-controlled study of paliperidone extended release for the treatment of acute manic and mixed episodes of bipolar I disorder

Efficacy and safety of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 52-week open-label studies

Safety and Tolerability of Oral Paliperidone Extended-Release Tablets in Elderly Patients With Schizophrenia: A Double-Blind, Placebo-Controlled Study With Six-Month Open-Label Extension

On clinical trials with a high placebo response rate

Efficacy and Safety of Flexibly Dosed Esketamine Nasal Spray Combined With a Newly Initiated Oral Antidepressant in Treatment-Resistant Depression: A Randomized Double-Blind Active-Controlled Study

Esketamine Nasal Spray for Rapid Reduction of Major Depressive Disorder Symptoms in Patients Who Have Active Suicidal Ideation With Intent: Double-Blind, Randomized Study (ASPIRE I)

Efficacy and Safety of Esketamine Nasal Spray Plus an Oral Antidepressant in Elderly Patients With Treatment-Resistant Depression—TRANSFORM-3

Efficacy and Safety of Intranasal Esketamine Adjunctive to Oral Antidepressant Therapy in Treatment-Resistant Depression: A Randomized Clinical Trial

Efficacy of Esketamine Nasal Spray Plus Oral Antidepressant Treatment for Relapse Prevention in Patients With Treatment-Resistant Depression: A Randomized Clinical Trial

Esketamine Nasal Spray for Rapid Reduction of Depressive Symptoms in Patients With Major Depressive Disorder Who Have Active Suicide Ideation With Intent: Results of a Phase 3, Double-Blind, Randomized Study (ASPIRE II)

Guidelines for the Content of Statistical Analysis Plans in Clinical Trials

Efficacy and Safety of Fixed-Dose Esketamine Nasal Spray Combined With a New Oral Antidepressant in Treatment-Resistant Depression: Results of a Randomized, Double-Blind, Active-Controlled Study (TRANSFORM-1)

A Double-Blind, Randomized, Placebo-Controlled, Dose-Frequency Study of Intravenous Ketamine in Patients With Treatment-Resistant Depression

Sample size increase during a survival trial when interim results are promising

Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: A randomized, double-blind, placebo-controlled study

Esketamine Nasal Spray Plus Oral Antidepressant in Patients With Treatment-Resistant Depression: Assessment of Long-Term Safety in a Phase 3, Open-Label Study (SUSTAIN-2)

Assessing treatment benefit in the presence of placebo response using the sequential parallel comparison design

A Phase 2/3 Placebo-Controlled, Parallel Group, Randomized Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy: the ARISE study (P14-8.006)

A randomized, placebo- and active-controlled study of paliperidone extended-release as maintenance treatment in patients with bipolar I disorder after an acute manic or mixed episode

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