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A Growing Crisis in Schizophrenia Drug Development: Failing Signal Detection at North American and Other Clinical Trial Sites

The journal of clinical psychiatry, 2020-03, Vol.81 (2)

Laughren, Thomas P.

2020

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

The journal of clinical psychiatry, 2011-04, Vol.72 (4), p.464-472

2011

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Review of maintenance trials for major depressive disorder: a 25-year perspective from the US Food and Drug Administration

The journal of clinical psychiatry, 2014-03, Vol.75 (3), p.205-214

2014

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Impact of Obesity on Brexpiprazole Pharmacokinetics: Proposal for Improved Initiation of Treatment

Journal of clinical pharmacology, 2022-01, Vol.62 (1), p.55-65

2022

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

The journal of clinical psychiatry, 2012-06, Vol.73 (6), p.856-864

2012

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What's next after 50 years of psychiatric drug development: an FDA perspective

The journal of clinical psychiatry, 2010-09, Vol.71 (9), p.1196-1204

Laughren, Thomas P

2010

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CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration's new dosing recommendations

The journal of clinical psychiatry, 2012-09, Vol.73 (9), p.1187-1190

2012

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Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant

The journal of clinical psychiatry, 2011-09, Vol.72 (9), p.1166-1173

2011

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Suicide rates in short-term randomized controlled trials of newer antidepressants

Journal of clinical psychopharmacology, 2006-04, Vol.26 (2), p.203-207

2006

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Development of a placebo effect model combined with a dropout model for bipolar disorder

Journal of pharmacokinetics and pharmacodynamics, 2013-06, Vol.40 (3), p.359-368

2013

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Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials

Innovations in clinical neuroscience, 2013-05, Vol.10 (5-6 Suppl A), p.4S-19S

2013

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Female reproductive life cycle and hormones: methodology to improve clinical trials

The journal of clinical psychiatry, 2013-10, Vol.74 (10), p.1018

2013

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An integrated approach for establishing dosing recommendations: paliperidone for the treatment of adolescent schizophrenia

Journal of clinical psychopharmacology, 2013-04, Vol.33 (2), p.152-156

2013

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Trial design issues and treatment effect modeling in multi-regional schizophrenia trials

Pharmaceutical statistics : the journal of the pharmaceutical industry, 2010-07, Vol.9 (3), p.217-229

2010

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Commentary on “Regulatory issues in drug development programs targeting cognitive impairment in schizophrenia”

European neuropsychopharmacology, 2013-08, Vol.23 (8), p.784-785

Laughren, Thomas

2013

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Comorbid mood disorders and medical illness: a Food and Drug Administration perspective

Biological psychiatry (1969), 2003-08, Vol.54 (3), p.195-199

Laughren, Thomas P

2003

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FDA Perspective on the DSM-5 Approach to Classification of “Cognitive” Disorders

The journal of neuropsychiatry and clinical neurosciences, 2011-04, Vol.23 (2), p.126-131

Laughren, Thomas

2011

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Impact of Obesity on Brexpiprazole Pharmacokinetics: Proposal for Improved Initiation of Treatment

Obesity (Silver Spring, Md.), 2022-11, Vol.30, p.245-245

2022

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Mitigating the Effects of Nonadherence in Clinical Trials

Journal of clinical pharmacology, 2016-09, Vol.56 (9), p.1151-1164

2016

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Why Are Innovative Drugs Failing in Phase III?

The American journal of psychiatry, 2017-09, Vol.174 (9), p.829-831

2017

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Developing novel treatments for mood disorders: accelerating discovery

Biological Psychiatry, 2002-09, Vol.52 (6), p.589-609

2002

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Food and Drug Administration commentary on methodological issues in negative symptom trials

Schizophrenia bulletin, 2011-03, Vol.37 (2), p.255-256

2011

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The FDA-NIMH-MATRICS Guidelines for Clinical Trial Design of Cognitive-Enhancing Drugs: What Do We Know 5 Years Later?

Schizophrenia bulletin, 2011-11, Vol.37 (6), p.1209-1217

2011

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The Importance of Adequately Powered Clinical Studies: Response to Khan et al

The American journal of psychiatry, 2018-02, Vol.175 (2), p.188-189

2018

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Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration

BMJ, 2009-08, Vol.339 (aug11 2), p.b2880-b2880

2009

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A Growing Crisis in Schizophrenia Drug Development: Failing Signal Detection at North American and Other Clinical Trial Sites

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

Review of maintenance trials for major depressive disorder: a 25-year perspective from the US Food and Drug Administration

Impact of Obesity on Brexpiprazole Pharmacokinetics: Proposal for Improved Initiation of Treatment

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

What's next after 50 years of psychiatric drug development: an FDA perspective

CYP2D6 genotype information to guide pimozide treatment in adult and pediatric patients: basis for the U.S. Food and Drug Administration's new dosing recommendations

Vilazodone: clinical basis for the US Food and Drug Administration's approval of a new antidepressant

Suicide rates in short-term randomized controlled trials of newer antidepressants

Development of a placebo effect model combined with a dropout model for bipolar disorder

Defining a clinically meaningful effect for the design and interpretation of randomized controlled trials

Female reproductive life cycle and hormones: methodology to improve clinical trials

An integrated approach for establishing dosing recommendations: paliperidone for the treatment of adolescent schizophrenia

Trial design issues and treatment effect modeling in multi-regional schizophrenia trials

Commentary on “Regulatory issues in drug development programs targeting cognitive impairment in schizophrenia”

Comorbid mood disorders and medical illness: a Food and Drug Administration perspective

FDA Perspective on the DSM-5 Approach to Classification of “Cognitive” Disorders

Impact of Obesity on Brexpiprazole Pharmacokinetics: Proposal for Improved Initiation of Treatment

Mitigating the Effects of Nonadherence in Clinical Trials

Why Are Innovative Drugs Failing in Phase III?

Developing novel treatments for mood disorders: accelerating discovery

Food and Drug Administration commentary on methodological issues in negative symptom trials

The FDA-NIMH-MATRICS Guidelines for Clinical Trial Design of Cognitive-Enhancing Drugs: What Do We Know 5 Years Later?

The Importance of Adequately Powered Clinical Studies: Response to Khan et al

Risk of suicidality in clinical trials of antidepressants in adults: analysis of proprietary data submitted to US Food and Drug Administration

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