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Maternal and Newborn Hospital Outcomes of Perinatal SARS-CoV-2 Infection: A National Registry

Hudak, Mark L; Falnnery, Dustin D; Barnette, Kimberly; Getzlaff, Trace; Gautam, Shiva; Dhudasia, Miren B; Mukhopadhyay, Sagori; Pfeifer, Madeline R; Ellington, Sascha R; Galang, Romeo R; Snead, Margaret C; Woodworth, Kate R; Zapata, Lauren B; Puopolo, Karen M; [Verma, Sourabh; Auyeung, NS Freda; Vaz, Michelle]
ISSN: 1098-4275
CID: 5430022

Outcomes of Maternal-Newborn Dyads After Maternal SARS-CoV-2

Verma, Sourabh; Bradshaw, Chanda; Auyeung, N S Freda; Lumba, Rishi; Farkas, Jonathan S; Sweeney, Nicole B; Wachtel, Elena V; Bailey, Sean M; Noor, Asif; Kunjumon, Bgee; Cicalese, Erin; Hate, Rahul; Lighter, Jennifer L; Alessi, Samantha; Schweizer, William E; Hanna, Nazeeh; Roman, Ashley S; Dreyer, Benard; Mally, Pradeep V
PMID: 32737153
ISSN: 1098-4275
CID: 4553402

The impact of escitalopram on IL-2-induced neuroendocrine, immune, and behavioral changes in patients with malignant melanoma: preliminary findings

Musselman, Dominique; Royster, Erica B; Wang, Ming; Long, Qi; Trimble, Lisa M; Mann, Tara K; Graciaa, Daniel S; McNutt, Marcia D; Auyeung, N S Freda; Oliver, Lindsay; Lawson, David H; Miller, Andrew H
Interleukin (IL)-2, a T-cell cytokine used to treat malignant melanoma, can induce profound depression. To determine whether pretreatment with the antidepressant escitalopram could reduce IL-2-induced neuroendocrine, immune, and neurobehavioral changes, 20 patients with Stage IV melanoma were randomized to either placebo or the serotonin reuptake inhibitor, escitalopram (ESC) 10-20 mg/day, 2 weeks before, and during IL-2 treatment (720 000 units/kg Q8 h x 5 days (1 cycle) every 3 weeks x 4 cycles). Generalized estimation equations were used to examine HPA axis activity (plasma ACTH and cortisol), immune activation (plasma IL-6), and depressive symptoms (Hamilton Depression Rating Scale (HDRS) score). Tolerance of IL-2 treatment (concomitant medications required) and adherence (number of IL-2 doses received) were also assessed. Both the groups (ESC (n=9), placebo (n=11)) exhibited significant IL-2-induced increases in plasma cortisol, IL-6, and depressive symptoms (p<0.05), as well as a temporal trend for increases in plasma ACTH (p=0.054); the effects of age and treatment were not significant. Higher plasma ACTH concentrations were associated with higher depressive symptoms during cycles 1-3 of IL-2 therapy (p<0.01). Although ESC had no significant effects on ACTH, cortisol, IL-6, tolerance of, or adherence to IL-2, ESC treatment was associated with lower depressive symptoms, ie, a maximal difference of approximately 3 points on the HDRS, which, though not statistically significant (in part, due to small sample size), represents a clinically significant difference according to the National Institute for Health and Clinical Excellence guidelines. A larger sample size will establish whether antidepressant pretreatment can prevent IL-2-induced neurobehavioral changes.
PMID: 23575741
ISSN: 1740-634x
CID: 2714652

Sequential multiple-assignment randomized trial design of neurobehavioral treatment for patients with metastatic malignant melanoma undergoing high-dose interferon-alpha therapy

Auyeung, S Freda; Long, Qi; Royster, Erica Bruce; Murthy, Smitha; McNutt, Marcia D; Lawson, David; Miller, Andrew; Manatunga, Amita; Musselman, Dominique L
BACKGROUND:Interferon-alpha therapy, which is used to treat metastatic malignant melanoma, can cause patients to develop two distinct neurobehavioral symptom complexes: a mood syndrome and a neurovegetative syndrome. Interferon-alpha effects on serotonin metabolism appear to contribute to the mood and anxiety syndrome, while the neurovegetative syndrome appears to be related to interferon-alpha effects on dopamine. PURPOSE/OBJECTIVE:Our goal is to propose a design for utilizing a sequential, multiple assignment, randomized trial design for patients with malignant melanoma to test the relative efficacy of drugs that target serotonin versus dopamine metabolism during 4 weeks of intravenous, then 8 weeks of subcutaneous, interferon-alpha therapy. METHODS:Patients will be offered participation in a double-blinded, randomized, controlled, 14-week trial involving two treatment phases. During the first month of intravenous interferon-alpha therapy, we will test the hypotheses that escitalopram will be more effective in reducing depressed mood, anxiety, and irritability, whereas methylphenidate will be more effective in diminishing interferon-alpha-induced neurovegetative symptoms, such as fatigue and psychomotor slowing. During the next 8 weeks of subcutaneous interferon therapy, participants whose symptoms do not improve significantly will be randomized to the alternate agent alone versus escitalopram and methylphenidate together. RESULTS:We present a prototype for a single-center, sequential, multiple assignment, randomized trial, which seeks to determine the efficacy of sequenced and targeted treatment for the two distinct symptom complexes suffered by patients treated with interferon-alpha. LIMITATIONS/CONCLUSIONS:Because we cannot completely control for external factors, a relevant question is whether or not 'short-term' neuropsychiatric interventions can increase the number of interferon-alpha doses tolerated and improve long-term survival. CONCLUSIONS:This sequential, multiple assignment, randomized trial proposes a framework for developing optimal treatment strategies; however, additional studies are needed to determine the best strategy for treating or preventing neurobehavioral symptoms induced by the immunotherapy interferon-alpha.
PMID: 19786415
ISSN: 1740-7753
CID: 4569052