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

Several first-line antidepressant therapies are currently available for the treatment of major depressive disorder (MDD), but in most patients depression fail to remits after an initial medication trial. In this chapter, we explore the evidence for different augmentation strategies used to enhance the response from an initial antidepressant monotherapy. Atypical antipsychotics, several of which are now approved by the US Food and Drug Administration as adjunctive agents for the treatment of MDD, and lithium are among the most evidence-based augmentation pharmacotherapies. Other therapies, such as bupropion, mirtazapine, triiodothyronine, nutraceuticals, and psychotherapy, are also commonly used. Additionally, several investigational drugs, including ketamine, esketamine, and ALKS 5461, with novel mechanisms of action, show promise.

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2020 FDA TIDES (Peptides and Oligonucleotides) Harvest

Pharmaceuticals ◽

10.3390/ph14020145 ◽

2021 ◽

Vol 14 (2) ◽

pp. 145

Author(s):

Othman Al Musaimi ◽

Danah Al Shaer ◽

Fernando Albericio ◽

Beatriz de la Torre

Keyword(s):

Adverse Effects ◽

Global Health ◽

Drug Administration ◽

Mode Of Action ◽

Chemical Structure ◽

Food And Drug Administration ◽

Health Crisis ◽

New Drug ◽

Target Mode ◽

The Us

2020 has been an extremely difficult and challenging year as a result of the coronavirus disease 2019 (COVID-19) pandemic and one in which most efforts have been channeled into tackling the global health crisis. The US Food and Drug Administration (FDA) has approved 53 new drug entities, six of which fall in the peptides and oligonucleotides (TIDES) category. The number of authorizations for these kinds of drugs has been similar to that of previous years, thereby reflecting the consolidation of the TIDES market. Here, the TIDES approved in 2020 are analyzed in terms of chemical structure, medical target, mode of action, and adverse effects.

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Aggregation and analysis of secondary pharmacology data from investigational new drug submissions at the US Food and Drug Administration

Journal of Pharmacological and Toxicological Methods ◽

10.1016/j.vascn.2021.107098 ◽

2021 ◽

pp. 107098

Author(s):

Andrew Dodson ◽

Kevin Mi ◽

Daniel P. Russo ◽

Christina Scott ◽

Muriel Saulnier ◽

...

Keyword(s):

Drug Administration ◽

Food And Drug Administration ◽

New Drug ◽

The Us

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Comorbidity of DSM–III–R Major Depressive Disorder in the General Population: Results from the US National Comorbidity Survey

The British Journal of Psychiatry ◽

10.1192/s0007125000298371 ◽

1996 ◽

Vol 168 (S30) ◽

pp. 17-30 ◽

Cited By ~ 579

Author(s):

R. C. Kessler ◽

C. B. Nelson ◽

K. A. McGonagle ◽

J. Liu ◽

M. Swartz ◽

...

Keyword(s):

Major Depressive Disorder ◽

General Population ◽

Depressive Disorder ◽

Composite International Diagnostic Interview ◽

Population Data ◽

Diagnostic Interview ◽

Prior History ◽

Major Depressive ◽

National Comorbidity Survey ◽

The Us

General population data are presented on the prevalence and correlates of comorbidity between DSM–III–R major depressive disorder (MDD) and other DSM–III–R disorders. The data come from the US National Comorbidity Survey, a large general population survey of persons aged 15–54 years in the non-institutionalised civilian population. Diagnoses are based on a modified version of the Composite International Diagnostic Interview (CIDI). The analysis shows that most cases of lifetime MDD are secondary, in the sense that they occur in people with a prior history of another DSM–III–R disorder. Anxiety disorders are the most common primary disorders. The time-lagged effects of most primary disorders on the risk of subsequent MDD continue for many years without change in magnitude. Secondary MDD is, in general, more persistent and severe than pure or primary MDD. This has special public health significance because lifetime prevalence of secondary MDD has increased in recent cohorts, while the prevalence of pure and primary depression has remained unchanged.

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Antidepressants Augmented with Aripiprazole in the Treatment of Major Depressive Disorder

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.1977 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S141-S141

Author(s):

S. Bise ◽

G. Sulejmanpasic ◽

D. Begic ◽

M. Ahmic

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Low Dose ◽

Adjunctive Treatment ◽

Major Depressive ◽

The Us ◽

Minimal Improvement ◽

History Of ◽

The Mean ◽

Ad Therapy

IntroductionMajor depressive disorder (MDD) does not consistently respond to any single antidepressant (AD) therapy. Adjunctive therapy with atypical antipsychotics (AA) showed higher response rates compared with AD monotherapy. Aripiprazole, an oral quinolinone, is the first AA agent to be approved in the US as adjunctive treatment in adult patients with MDD.Aim The aim was to evaluate the efficacy and safety of adjunctive low-dose aripiprazole combined with AD versus AD monotherapy in patients with MDD with minimal improvement after 4 weeks of prior AD monotherapy.MethodsTen patients with MDD and a history of minimal improvement to 4 weeks of AD monotherapy (escitalopram 10–15 mg/day, sertralin 50–100 mg/day) were included in this study. The patients were randomly assigned to 2 groups: one (n = 5) with AD plus aripiprazole 5–7.5 mg/day and the other (n = 5) with AD alone. After baseline assessment, the subjects were followed up at weeks 2, and 4. The primary efficacy was the mean change in (HAM-D17) and CGI-I.ResultsThe aripiprazole group exhibited significantly better efficacy than the AD group in mean total score changes of HAM-D17 and CGI from the baseline to weeks 2, and 4. The item “work and social activities” of HAM-D 17 showed significant improvement at week 4, and the item “somatic symptoms (GI)” showed significant improvement at week 2.ConclusionsAdjunctive aripiprazole therapy significantly improved depressive symptoms in MDD who didn’t respond to AD monotherapy. Aripiprazole augmentation is an efficacious, well-tolerated and safe treatment for patients with MDD.

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Using genetic drug-target networks to develop new drug hypotheses for major depressive disorder

Translational Psychiatry ◽

10.1038/s41398-019-0451-4 ◽

2019 ◽

Vol 9 (1) ◽

Cited By ~ 14

Author(s):

Héléna A. Gaspar ◽

◽

Zachary Gerring ◽

Christopher Hübel ◽

Christel M. Middeldorp ◽

...

Keyword(s):

Major Depressive Disorder ◽

Depressive Disorder ◽

Drug Target ◽

Major Depressive ◽

New Drug

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The NIMH MATRICS Initiative: Development of a Consensus Cognitive Battery

Progress in Neurotherapeutics and Neuropsychopharmacology ◽

10.1017/s1748232106000127 ◽

2006 ◽

Vol 2 (1) ◽

pp. 173-186 ◽

Cited By ~ 1

Author(s):

Robert S. Kern ◽

Michael F. Green ◽

Stephen R. Marder

Keyword(s):

Drug Administration ◽

Cognitive Deficits ◽

Food And Drug Administration ◽

New Drugs ◽

Step Process ◽

New Drug ◽

The Us ◽

Treatment Research ◽

Broad Consensus

ABSTRACTA key obstacle to the development of new drugs to treat the cognitive deficits of schizophrenia was the absence of a standard by which to measure their efficacy. Before granting approval for any new drug for this condition, the US Food and Drug Administration wanted a standard cognitive endpoint based on a broad consensus-based method. To address this obstacle, the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) intiative oversaw a process to develop a consensus neurocognitive battery. Its development included a ten-step process that is described in this article.

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