News & Resources

The Alzheimer’s Association external quality control program for cerebrospinal fluid biomarkers

2011 The Alzheimer’s Association, January 2025

The cerebrospinal fluid (CSF) biomarkers amyloid β (Aβ)-42, total-tau (T-tau), and phosphorylated-tau (P-tau) demonstrate good diagnostic accuracy for Alzheimer’s disease(AD). However, there are large variations in biomarker measurements between studies, andbetween and within laboratories. The Alzheimer’s Association has initiated a global qualitycontrol program to estimate and monitor variability of measurements, quantify batch-to-batchassay variations, and identify…

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Lurasidone in Post-menopausal Females With Major Depressive Disorder With Mixed Features–Post-hoc Analysis of a Placebo-Controlled Trial

John Sramek, Antony Loebel, Michael Murphy, Yongcai Mao, Andrei Pikalov, Neal R. Cutler, January 2025

Several studies have found that depressed, post-menopausal females may respond differently toantidepressants compared to pre-menopausal females. The atypical antipsychotic lurasidone, whose mechanism of action differs from SSRIs and other standard antidepressants, was shown in a 6-week randomized, flexibledose, placebo-controlled study (n = 209), to be effective in treating major depressive disorder (MDD) with mixed features…

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Exploratory Biomarker Study of the Triple Reuptake InhibitorSEP-432 Compared to the Dual Reuptake Inhibitor Duloxetinein Healthy Normal Subjects

John J. Sramek, 1 Larry W. Hardy, 2 Peter Bieck, 1 Cynthia Zamora, 3 Mark Versavel, 2 Jahnavi Kharidia, 2 Todd Grinnell, 2 Yu-Luan Chen, 2 Michael Sullivan, 3 Hong Ding 1 & Neal R. Cutler, January 2025

SEP-432 is a triple monoamine reuptake inhibitor of norepinephrine (NE),serotonin (5-HT), and dopamine (DA), based on invitro binding studies. We sought evidence that SEP-432 engages these monoamine systems by measuring concentrations of monoamines and/or their main metabolites in cerebrospinal fluid (CSF) and plasma and comparing results to duloxetine, a dual reuptake inhibitor of NE and…

Read More: Exploratory Biomarker Study of the Triple Reuptake InhibitorSEP-432 Compared to the Dual Reuptake Inhibitor Duloxetinein Healthy Normal Subjects
Press Mentions Thought Leadership
A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials

Journal for Clinical Studies | Volume 10: Issue 1, September 2024

As psychiatric drug development advances towards more personalised medicine, the role of biomarkers has become integral to the investigation of the safety, tolerability and efficacy of a range of psychiatric drugs. Biomarkers can aid in the development of novel therapeutic agents by supporting patient selection or enriching trials with patients more likely to have a…

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Thought Leadership
Sex Differences in the Psychopharmacological Treatment of Depression

Dialogues in Clinical Neuroscience | Volume 18: Issue 4, January 2016

Although a number of studies have observed that females respond better to serotonergic antidepressants than males and that postmenopausal females have a diminished response to antidepressants compared with younger females, there are also studies that conflict with both of these findings, making any generalizations regarding sex differences difficult to make. Sex variance in antidepressant efficacy…

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Balancing Risk and Benefit in Venous Thromboembolism Trials: Concept for a Bivariate Endpoint Trial Design and Analytic Approach

Published in final edited form as: J Thromb Haemost., August 2013

Concept for a Bivariate Endpoint Trial Design and Analytic Approach

Read More: Balancing Risk and Benefit in Venous Thromboembolism Trials: Concept for a Bivariate Endpoint Trial Design and Analytic Approach
Press Mentions Thought Leadership

News & Resources

The Alzheimer’s Association external quality control program for cerebrospinal fluid biomarkers

Lurasidone in Post-menopausal Females With Major Depressive Disorder With Mixed Features–Post-hoc Analysis of a Placebo-Controlled Trial

Exploratory Biomarker Study of the Triple Reuptake InhibitorSEP-432 Compared to the Dual Reuptake Inhibitor Duloxetinein Healthy Normal Subjects

A Methodology for Advancing the Selection of Biomarkers for Use in Psychiatric Clinical Trials

Sex Differences in the Psychopharmacological Treatment of Depression

Balancing Risk and Benefit in Venous Thromboembolism Trials: Concept for a Bivariate Endpoint Trial Design and Analytic Approach

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