Justine Kent

Merck & Co., Inc., Rahway, NJ, USA (United States)

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Jack M. Gorman

The Bronx Defenders

Jeremy D. Coplan

State University of New York

Antony Loebel

Vion Pharmaceuticals (United States)

Gregory M. Sullivan

Eloxx Pharmaceuticals (United States)

Robert Goldman

Sumitomo Dainippon Pharma (United States)

Peter de Boer

University of Groningen

Kenneth S. Koblan

Sumitomo Dainippon Pharma (United States)

Luc Van Nueten

Janssen (Belgium)

Seth C. Hopkins

Sumitomo Dainippon Pharma (United States)

Laszlo A. Papp

University of Szeged

Cooperative Institutions

Janssen (Belgium)

Columbia University

Janssen (United States)

New York State Psychiatric Institute

Johnson & Johnson (United States)

New York Psychoanalytic Society and Institute

Columbia University Irving Medical Center

Yale University

Sunovion (United States)

Vion Pharmaceuticals (United States)

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The selective orexin-2 receptor antagonist seltorexant improves sleep: An exploratory double-blind, placebo controlled, crossover study in antidepressant-treated major depressive disorder patients with persistent insomnia

Journal of Psychopharmacology (2019)

Sander Brooks Gabriël E. Jacobs Peter de Boer Justine Kent Luc Van Nueten

Background: Insomnia is common in patients with major depressive disorder. Although antidepressants improve mood, insomnia often persists as a result of physiological hyperarousal. The orexin-2 receptor is increasingly being recognized as a new target for the treatment of persistent insomnia in major depressive disorder . Aim: This exploratory study investigated the effects of seltorexant on objective sleep parameters and subjective depressive symptoms in antidepressant treated major depressive disorder patients with persistent insomnia. Methods: Twenty male and female patients received a single dose of 10, 20, 40 mg seltorexant and placebo with a washout period of seven days in a double-blind four-way crossover study. Effects on latency to persistent sleep, total sleep time and sleep efficiency were assessed with polysomnography. Subjective changes in mood were explored by the Quick Inventory of Depressive Symptomatology Self-Report. Safety was recorded and suicidal ideation and behavior were assessed with the Columbia Suicide Severity Rating Scale. Results: Latency to persistent sleep was significantly shorter for all doses of seltorexant compared to placebo. Placebo least square mean was 61.05 min with least square mean ratios treatment/placebo (80% confidence interval) of 0.32 (0.24–0.44), 0.15 (0.11–0.2) and 0.17 (0.12–0.23) 19.69, 9.2, 10.15 for 10, 20 and 40 mg seltorexant respectively, (all p<0.001). Total sleep time was significantly longer for all doses of seltorexant compared to placebo. Sleep efficiency was significantly improved. The Quick Inventory of Depressive Symptomatology Self-Report demonstrated a trend to mood-improvement for the 40 mg group. Conclusions: Seltorexant showed a statistically significant, dose-dependent decrease in latency to persistent sleep, and increase in total sleep time and sleep efficiency combined with a tendency toward subjectively improved mood.

Crossover study

10.1177/0269881118822258

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Citations (52)

P.370 Impact of full versus partial response on signal detection in placebo-controlled schizophrenia trials

European Neuropsychopharmacology (2019)

Antony Loebel Andrei Pikalov C. Siu J. Hsu Michael Tocco

Mexiletine

Clinical endpoint

Sodium channel blocker

Supraventricular arrhythmia

10.1016/j.euroneuro.2019.09.386

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Citations (0)

Risk of Cardiovascular Morbidity With Risperidone or Paliperidone Treatment

Journal of Clinical Psychopharmacology (2013)

Srihari Gopal David Hough Keith Karcher Isaac Nuamah Joseph Palumbo

A post hoc analysis of the risperidone (RIS)/paliperidone (Pali) clinical trials database comprising 64 studies was conducted. Risk of sudden death, cardiovascular (CV), and cerebrovascular events during RIS or Pali treatment was estimated. Treatment emergent CV adverse events were identified using 7 prespecified Standardised MedDRA Queries as follows: embolic/thrombotic events, cerebrovascular disorders, ischemic heart disease, cardiac arrhythmias, cardiac failure, torsades/QT prolongation, and convulsions. Risk in the RIS/Pali pooled group was significantly increased compared to placebo for the following adverse events: syncope, tachycardia, palpitations, edema peripheral, dysarthria, and transient ischemic attack. Incidence of death related to CV events was low and similar across groups. Consistent with the known pharmacologic profile and product information, this analysis of treatment emergent adverse event data from a large, randomized, controlled clinical trials database described increased risk versus placebo for several specific CV events. Apart from events described in existing product labeling, no new safety findings emerged.

MedDRA

Paliperidone

Palpitations

Torsades de pointes

10.1097/jcp.0b013e318283983f

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Citations (32)

Occupancy of brain serotonin transporters during treatment with paroxetine in patients with social phobia: a positron emission tomography study with [ 11 C]McN 5652

Psychopharmacology (2002)

Justine Kent Jeremy D. Coplan Ilise Lombardo Dah‐Ren Hwang Yiyun Huang

Paroxetine

Serotonin reuptake inhibitor

10.1007/s00213-002-1218-8

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Citations (69)

Efficacy and Safety of Dasotraline in Children With ADHD: A Laboratory Classroom Study

Journal of Attention Disorders (2019)

Sharon B. Wigal Seth C. Hopkins Kenneth S. Koblan Ann Childress Justine Kent

Objective: To evaluate the efficacy and safety of dasotraline for treatment of ADHD in children. Method: Children (ages 6-12 years; N = 112) with ADHD were randomized, double-blind, to 14 days of once-daily evening doses of dasotraline 4 mg or placebo. ADHD symptom severity was measured at baseline and Day 15 in seven, 30-min classroom sessions using the Swanson, Kotkin, Agler, M-Flynn, and Pelham (SKAMP) and the Permanent Product Measure of Performance (PERMP) math test. Results: Significant improvement was observed for dasotraline versus placebo in the SKAMP-combined score (−3.2 vs. +2.0; p < .001; effect size = 0.85) and SKAMP and PERMP subscale scores. The three most common adverse events for dasotraline (vs. placebo) were insomnia (19.6% vs. 3.6%), headache (10.7% vs. 8.9%), and decreased appetite (10.7% vs. 3.6%). Conclusion: In this laboratory classroom study, dasotraline 4 mg was found to be an efficacious and generally well-tolerated treatment for ADHD in children aged 6 to 12 years.

10.1177/1087054719864644

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Citations (23)

Positron emission tomography study of pindolol occupancy of 5-HT1A receptors in humans: preliminary analyses

Nuclear Medicine and Biology (2000)

Diana Martinez Osama Mawlawi Dah‐Ren Hwang Justine Kent Norman R. Simpson

Pindolol

5-HT1A receptor

Dorsal raphe nucleus

10.1016/s0969-8051(00)00122-0

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Citations (22)

Differential occupancy of 5HT-1A autoreceptors and post-synaptic receptors by pindolol in humans measured with PET and [ 11C-carbonyl] WAY 100635

Diana Martínez Dah Ren Hwang Osama Mawlawi Justine Kent Tomoki Hashimoto

Pindolol

Autoreceptor

Occupancy

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Citations (0)

Correction to: The selective orexin-2 antagonist seltorexant (JNJ-42847922/MIN-202) shows antidepressant and sleep-promoting effects in patients with major depressive disorder

Translational Psychiatry (2019)

Kasper Recourt Peter de Boer Rob Zuiker R. Luthringer Justine Kent

In the original Article, Tables two and three had formatting issues which affected their clarity. This has been corrected in the PDF and HTML versions of this Article.

CLARITY

Disk formatting

Orexin-A

10.1038/s41398-019-0585-4

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Citations (5)

Burden of EPS in commercial patients with schizophrenia initiating atypical antipsychotics

The American Journal of Managed Care (2022)

Aditi Kadakia Brenna L. Brady Carole Dembek G Rhys Williams Justine Kent

Extrapyramidal symptoms (EPS) affect 15% to 30% of patients with schizophrenia treated with antipsychotics and have been associated with poor outcomes. This study examined the incidence and economic burden of EPS in patients with schizophrenia initiating atypical antipsychotics (AAPs).Retrospective analysis of secondary deidentified administrative claims database.Patients with schizophrenia initiating AAPs with no prior EPS were identified in the MarketScan Commercial and Medicare Supplemental databases from January 1, 2012, to December 31, 2018. Incidence of EPS (diagnosis or medication use) was assessed in the year following AAP initiation. Annual all-cause and schizophrenia-related health care resource utilization (HCRU) and costs were assessed in cohorts who did or did not develop EPS in the year following first EPS claim (EPS cohort) or randomly assigned index date (non-EPS cohort). Multivariate regression was used to compare all-cause and schizophrenia-related total health care costs and inpatient admissions between cohorts.A total of 3558 patients with schizophrenia newly initiating AAPs were identified; 22.1% developed EPS in the year following AAP initiation (incidence: 26.9 cases per 100 person-years). Multivariate analyses revealed that patients with EPS had 34% higher odds of all-cause (odds ratio [OR], 1.3361; 95% CI, 1.0770-1.6575; P < .01) and 84% increased odds of schizophrenia-related (OR, 1.8436; 95% CI, 1.0434-2.4219; P < .0001) inpatient admission compared with the non-EPS cohort. The EPS cohort also evidenced significantly higher adjusted all-cause ($26,632 vs $21,273; P < .001) and schizophrenia-related ($9018 vs $4475; P < .0001) costs compared with the non-EPS cohort.The 20% of patients who developed EPS in the year following AAP initiation evidenced significantly increased HCRU and costs over the postindex period. Schizophrenia therapies with reduced EPS risk are needed to improve patient care.

Extrapyramidal symptoms

Odds

Diagnosis of schizophrenia

10.37765/ajmc.2022.89163

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Citations (2)

Effects of hyperventilation on heart rate and QT variability in panic disorder pre- and post-treatment

Psychiatry Research (2003)

Gregory M. Sullivan Justine Kent Marc Kleber Jose M. Martinez Vikram K. Yeragani

10.1016/j.psychres.2003.10.002

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Citations (42)