The Effects of Gastroretentive Gabapentin
(Gralise®) on Spinal Stenosis Patients with
Radicular Pain

Background: The health and efficacy profiles of Gralise® in the treatment of pain from spinal stenosis and radicular symptomatology have not been measured. A review of the current literature indicates that no studies exist that evaluate the safety and efficacy profiles of Gralise® in the treatment of pain from spinal stenosis and radicular symptomatology. Objective: Our study is aimed at determining whether Gralise is a safe and effective pharmacotherapy for the pain from spinal stenosis and radicular symptomatology. Study Design: A 4-week prospective open label single arm and single center study of patients with MRI diagnosis of spinal stenosis with radicular pain. Methods: The primary measure of efficacy was a change in average daily pain (ADP) score from baseline to completion of Gralise therapy for 4 weeks. The secondary efficacy endpoints were the patients’ Patients Global Impression of Change Scale (PGIC), the clinician’s Clinical Global Impression of Change Scale (CGI) reports, and the Medical Outcomes Study (MOS) sleep scale of improvement from baseline to completing 4 weeks of Gralise therapy. The safety and tolerability were evaluated by the incidence of adverse events reported while on Gralise therapy. Setting: The study was performed at the Clinical Research Facilities at Tulane Medical Center, New Orleans, Louisiana, in the period from December 1, 2012, to August 30, 2013. Results: Thirty-five patients achieved an efficacy point of one-week Gralise medication treatment. Twenty-seven of 35 (77.2%) patients completed all 5 visits. The PGIC noted a significant positive change in: (1) activity limitations; (2) symptoms; (3) emotions and overall quality of life when related to their condition from first visit as well as improved degree of change when related to their condition from first to last visit. The MOS sleep scale and sleep diaries noted a significant increase of hours slept on average (an increase in over one hour per night — 5.8 hours versus 6.86 hours) from the beginning of the study to the end. The CGI noted a majority of 10 out of 27 with marked significant therapeutic effect with no side effects. The ADP rating from pain intensity scale and pain diaries noted significant improvement of lesser levels of pain experienced (P =.5907 and P =.8547 respectively). No significant adverse effects were noted in the study. Limitations: Variation in degree of spinal stenosis, small sample size. Conclusions: Gralise demonstrated moderate efficacy with reduced pain intensity and increased sleep and was well tolerated in spinal stenosis patients with radicular symptoms. Key words: Spinal stenosis, gabapentin, Gralise®, radicular pain, neuropathic pain

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Pain perception in chronic knee osteoarthritis with varying levels of pain inhibitory control: an exploratory study

Scandinavian Journal of Pain ◽

10.1515/sjpain-2020-0016 ◽

2020 ◽

Vol 20 (4) ◽

pp. 651-661

Author(s):

Paulo E. P. Teixeira ◽

Hanan I. Zehry ◽

Swapnali Chaudhari ◽

Laura Dipietro ◽

Felipe Fregni

Keyword(s):

Knee Osteoarthritis ◽

Pain Intensity ◽

Pain Perception ◽

Small Sample Size ◽

Linear Regression Analysis ◽

Small Sample ◽

Pain Modulation ◽

Clinical Variables ◽

Pain Scores ◽

Intensity Perception

AbstractBackground and aimsPain is a disabling symptom in knee osteoarthritis (KOA) and its underlying mechanism remains poorly understood. Dysfunction of descending pain modulatory pathways and reduced pain inhibition enhance pain facilitation in many chronic pain syndromes but do not fully explain pain levels in chronic musculoskeletal conditions. The objective of this study is to explore the association of clinical variables with pain intensity perception in KOA individuals with varying levels of Conditioned Pain Modulation (CPM) response.MethodsThis is a cross-sectional, exploratory analysis using baseline data of a randomized clinical trial investigating the effects of a non-invasive brain stimulation treatment on the perception of pain and functional limitations due to KOA. Sixty-three subjects with KOA were included in this study. Data on pain perception, mood perception, self-reported depression, physical function, quality of life, and quantitative sensory testing was collected. Multiple linear regression analysis was performed to explore the association between the clinical variables with pain perception for individuals with different levels of CPM response.ResultsFor KOA patients with limited CPM response, perception of limitations at work/other activities due to emotional problems and stress scores were statistically significantly associated with pain scores, F(2, 37) = 7.02, p < 0.01. R-squared = 0.275. For KOA patients with normal CPM response, general health perception scores were statistically significantly associated with pain scores, F(1, 21) = 5.60, p < 0.05. R-squared = 0.2104. Limitations of this study include methodology details, small sample size and study design characteristics.ConclusionsPain intensity perception is associated differently with clinical variables according to the individual CPM response. Mechanistic models to explain pain perception in these two subgroups of KOA subjects are discussed.

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Abstract 248: Initiation and Assessment of Timekeeping Roles During In-Hospital Cardiac Arrests to Track Rhythm Checks and Epinephrine Dosing

Circulation ◽

10.1161/circ.140.suppl_2.248 ◽

2019 ◽

Vol 140 (Suppl_2) ◽

Author(s):

Conor Crowley ◽

Peter Clardy ◽

Jessica McCannon ◽

Rebecca Logiudice

Keyword(s):

Small Sample Size ◽

Medical Center ◽

Academic Medical Center ◽

Small Sample ◽

Post Intervention ◽

Epinephrine Administration ◽

Team Members ◽

Minute Post ◽

Chaotic Nature ◽

Strongly Agree

Introduction: Compliance to ACLS cardiac arrest algorithm is low and associated with worse outcomes from in-hospital cardiac arrests (IHCA). Reasons for non-compliance include reduced communication due to chaotic nature of IHCAs and difficulty timing epinephrine administration and rhythm check intervals. Hypothesis: Delegating two separate code team members for rhythm and epinephrine timing will increase adherence to ACLS algorithm during IHCAs. Methods: This is a pre-post interventional study of IHCAs at a single academic medical center. Two stopwatches were placed on all code carts and two new timekeeping roles were created. Education was provided to staff regarding the alteration of existing code team member roles for the use of stopwatches. Algorithm adherence was analyzed pre and post implementation of timekeeper roles. Deviation from the 2-minute rhythm check or 3-5-minute epinephrine administration was counted as one deviation. Anonymous surveys were delivered to evaluate providers perceived benefits of timekeeper roles for IHCAs. Results: Data from 13 pre intervention IHCAs were compared to 12 IHCAs post intervention. The initial rhythm was PEA/asystole in 69% pre-intervention vs 83% post intervention. Prior to implementation 82 deviations vs. 11 deviations post implementation occurred (p=0.006). The mean time until first dose of epinephrine was administered pre intervention was 2.3 ± 3.3 minutes vs 0.4 ±1 minute post. Pre-implementation ROSC rate was 53.8% vs. 66.7% post intervention. Surveys were delivered to 100% of code team members post intervention, with a 79% response rate. Surveys demonstrate providers felt time keeping roles made it easier to track epinephrine administration and rhythm checks. On a Likert scale, 78% of providers “strongly agree” that the use of timekeeping roles and devices improved code team communication. Conclusion: Two separate timekeeper roles during IHCAs improved algorithm compliance, code team function and communication, and was favored by code team members. Timekeeper roles may be associated with improved rates of ROSC and less time until the first dose of epinephrine is administered. This study is limited by its small sample size, single center and requires validation.

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Serial neuroimaging in infants with abusive head trauma: timing abusive injuries

Journal of Neurosurgery Pediatrics ◽

10.3171/2013.4.peds12596 ◽

2013 ◽

Vol 12 (2) ◽

pp. 110-119 ◽

Cited By ~ 41

Author(s):

Ray Bradford ◽

Arabinda K. Choudhary ◽

Mark S. Dias

Keyword(s):

Head Trauma ◽

Small Sample Size ◽

Medical Center ◽

Abusive Head Trauma ◽

Time Frame ◽

Small Sample ◽

Ct Scans ◽

Imaging Studies ◽

T1 Hyperintensity ◽

Clinical Records

Object The appearance and evolution of neuroimaging abnormalities following abusive head trauma (AHT) is important for establishing the time frame over which these injuries might have occurred. From a legal perspective this frames the timing of the abuse and therefore identifies and excludes potential perpetrators. A previous pilot study involving 33 infants with AHT helped to refine the timing of these injuries but was limited by its small sample size. In the present study, the authors analyzed a larger group of 210 cases involving infants with AHT to chronicle the first appearance and evolution of radiological (CT, MRI) abnormalities. Methods All children younger than 24 months admitted to the Penn State Hershey Medical Center with AHT over a 10-year period were identified from a medical record review; the time of injury was determined through an evaluation of the clinical records. All imaging studies were analyzed, and the appearance and evolution of abnormalities were chronicled on serial neuroimaging studies obtained in the days and weeks after injury. Results One hundred five infants with specific injury dates and available imaging studies were identified; a subset of 43 children additionally had documented times of injury. In infants with homogeneously hyperdense subdural hematomas (SDHs) on initial CT scans, the first hypodense component appeared within the SDH between 0.3 and 16 days after injury, and the last hyperdense subdural component disappeared between 2 and 40 days after injury. In infants with mixed-density SDHs on initial scans, the last hyperdense component disappeared between 1 and 181 days. Parenchymal hypodensities appeared on CT scans performed as early as 1.2 hours, and all were visible within 27 hours after the injury. Rebleeding into SDHs was documented in 17 cases (16%) and was always asymptomatic. Magnetic resonance imaging of the brain was performed in 49 infants. Among those with SDH, 5 patterns were observed. Patterns I and II reflected homogeneous SDH; Pattern I (T1 hyperintensity and T2/FLAIR hypointensity, “early subacute”) more commonly appeared on scans performed earlier after injury compared with Pattern II (T1 hyperintensity and T2/FLAIR hyperintensity, “late subacute”), although there was considerable overlap. Patterns III and IV reflected heterogeneous SDH; Pattern III contained relatively equal mixtures having different intensities, whereas Pattern IV had fluid that was predominantly T1 hypointense and T2/FLAIR hyperintense. Again, Pattern III more commonly appeared on scans performed earlier after injury compared with Pattern IV, although there was significant overlap. Conclusions These data extend the preliminary data reported by Dias and colleagues and provide a framework upon which injuries in AHT can be timed as well as the limitations on such timing estimates.

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Bipolar Disorder and Comorbid Use of Illicit Substances

Medicina ◽

10.3390/medicina57111256 ◽

2021 ◽

Vol 57 (11) ◽

pp. 1256

Author(s):

Ulrich W. Preuss ◽

Martin Schaefer ◽

Christoph Born ◽

Heinz Grunze

Keyword(s):

Bipolar Disorder ◽

Substance Use ◽

Best Practices ◽

Multidisciplinary Approach ◽

Small Sample Size ◽

Basic Research ◽

Small Sample ◽

Epigenetic Alterations ◽

Open Label ◽

Addictive Disorders

Substance use disorders (SUD) are highly prevalent in bipolar disorder (BD) and significantly affect clinical outcomes. Incidence and management of illicit drug use differ from alcohol use disorders, nicotine use of behavioral addictions. It is not yet clear why people with bipolar disorder are at higher risk of addictive disorders, but recent data suggest common neurobiological and genetic underpinnings and epigenetic alterations. In the absence of specific diagnostic instruments, the clinical interview is conducive for the diagnosis. Treating SUD in bipolar disorder requires a comprehensive and multidisciplinary approach. Most treatment trials focus on single drugs, such as cannabis alone or in combination with alcohol, cocaine, or amphetamines. Synopsis of data provides limited evidence that lithium and valproate are effective for the treatment of mood symptoms in cannabis users and may reduce substance use. Furthermore, the neuroprotective agent citicoline may reduce cocaine consumption in BD subjects. However, many of the available studies had an open-label design and were of modest to small sample size. The very few available psychotherapeutic trials indicate no significant differences in outcomes between BD with or without SUD. Although SUD is one of the most important comorbidities in BD with a significant influence on clinical outcome, there is still a lack both of basic research and clinical trials, allowing for evidence-based and specific best practices.

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Evidence generation for the clinical impact of myCOPD in patients with mild, moderate and newly diagnosed COPD: a randomised controlled trial

ERJ Open Research ◽

10.1183/23120541.00460-2020 ◽

2020 ◽

Vol 6 (4) ◽

pp. 00460-2020

Author(s):

Michael G. Crooks ◽

Jack Elkes ◽

William Storrar ◽

Kay Roy ◽

Mal North ◽

...

Keyword(s):

Randomised Controlled Trial ◽

Usual Care ◽

Small Sample Size ◽

Controlled Trial ◽

Small Sample ◽

Self Management ◽

Open Label ◽

Management Interventions ◽

Randomised Controlled ◽

The Impact

Self-management interventions in COPD aim to improve patients' knowledge, skills and confidence to make correct decisions, thus improving health status and outcomes. myCOPD is a web-based self-management app known to improve inhaler use and exercise capacity in individuals with more severe COPD.We explored the impact of myCOPD in patients with mild–moderate or recently diagnosed COPD through a 12-week, open-label, parallel-group, randomised controlled trial of myCOPD compared with usual care. The co-primary outcomes were between-group differences in mean COPD assessment test (CAT) score at 90 days and critical inhaler errors. Key secondary outcomes were app usage and patient activation measurement (PAM) score.Sixty patients were randomised (29 myCOPD, 31 usual care). Groups were balanced for forced expiratory volume in 1 s (FEV1 % pred) but there was baseline imbalance between groups for exacerbation frequency and CAT score. There was no significant adjusted mean difference in CAT score at study completion, −1.27 (95% CI −4.47–1.92, p=0.44) lower in myCOPD. However, an increase in app use was associated with greater CAT score improvement. The odds of ≥1 critical inhaler error was lower in the myCOPD arm (adjusted OR 0.30 (95% CI 0.09–1.06, p=0.061)). The adjusted odds ratio for being in a higher PAM level at 90 days was 1.65 (95% CI 0.46–5.85) in favour of myCOPD.The small sample size and phenotypic difference between groups limited our ability to demonstrate statistically significant evidence of benefit beyond inhaler technique. However, our findings provide important insights into associations between increased app use and clinically meaningful benefit warranting further study in real world settings.

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Attentional functioning in patients with posttraumatic stress disorder: a preliminary study

CNS Spectrums ◽

10.1017/s1092852912000909 ◽

2013 ◽

Vol 18 (2) ◽

pp. 90-94 ◽

Cited By ~ 3

Author(s):

Michael David Horner ◽

Jacobo E. Mintzer ◽

Travis H. Turner ◽

Keith R. Edmiston ◽

Olga Brawman-Mintzer

Keyword(s):

Posttraumatic Stress Disorder ◽

Posttraumatic Stress ◽

Substance Dependence ◽

Stress Disorder ◽

Small Sample Size ◽

Medical Center ◽

Digit Span ◽

Cognitive Disorders ◽

Small Sample ◽

Psychiatric Diagnoses

ObjectiveTo compare patients with posttraumatic stress disorder (PTSD) to patients without psychiatric or cognitive disorders on neuropsychological measures of attention.MethodsThe sample included 19 patients with PTSD and 22 participants with no cognitive or psychiatric diagnosis. All had been referred for clinical neuropsychological evaluation at a VA Medical Center. None were diagnosed with dementia, delirium, or current substance dependence except nicotine or caffeine, and none had a history of stroke or of traumatic brain injury with loss of consciousness. Patients were excluded if they failed to exert adequate effort on testing.ResultsPTSD patients performed significantly more poorly than patients without psychiatric diagnoses on Digit Span.ConclusionPTSD patients were impaired relative to participants without psychiatric diagnoses on a measure of focused attention. Several factors, including the small sample size, suggest that the results should be considered preliminary.

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An open-label, multicenter, phase II study of ceritinib in patients with advanced ALK+ non-lung solid tumors and hematological malignancies (ASCEND-10).

Journal of Clinical Oncology ◽

10.1200/jco.2020.38.15_suppl.3520 ◽

2020 ◽

Vol 38 (15_suppl) ◽

pp. 3520-3520

Author(s):

Victor Moreno ◽

Tae Min Kim ◽

Sun Young Rha ◽

Federico Longo ◽

Sith Sathornsumetee ◽

...

Keyword(s):

Antitumor Activity ◽

Solid Tumors ◽

Hematological Malignancies ◽

Small Sample Size ◽

Stage Iv ◽

Small Sample ◽

Gamma Glutamyl Transferase ◽

Efficacy And Safety ◽

Open Label ◽

Glutamyl Transferase

3520 Background: Prior studies have confirmed the efficacy and safety of ceritinib in patients (pts) with advanced ALK+ non-small cell lung cancer (Soria, et al, Lancet 2017; Shaw et al, Lancet Oncol 2017; Cho et al, JTO 2019). Ceritinib also demonstrated antitumor activity in pediatric pts with ALK+ inflammatory myofibroblastic tumor (IMT) and ALCL (Georger et al, ASCO 2015 [abstract#10005]). Long-term clinical benefits of ceritinib treatment were shown in pts with anaplastic large cell lymphoma (ALCL) (Richly et al, Blood 2015). The aim of the current study was to examine ceritinib efficacy and safety in pts with advanced ALK+ non-lung solid tumors and hematological malignancies. Methods: In this open-label, multi-arm, phase 2 (NCT02465528) trial, adult pts with ALK gene abnormalities who had received ≥1 prior systemic therapy were administered oral ceritinib 750 mg/day, under fasted conditions. Primary endpoint: investigator assessed disease control rate (DCR); secondary endpoints: investigator assessed overall response rate (ORR), duration of response (DOR), time to response (TTR), progression-free survival (PFS), and safety. Results: Overall, 22 pts (ALCL [n = 1], IMT [n = 4], glioblastoma multiforme [GBM, n = 12] and others [n = 5]) were enrolled; median (m) age: 52.5 years; male: 50%; Stage ≥IV: 95.4%. Key efficacy results are shown in the Table. mTTR in pts with confirmed complete response (CR) or partial response (PR) [n = 4] was 7.4 (range, 6–25) weeks. mDOR was not reached. mPFS (95% CI) was 2.6 (1.6, 3.7) weeks. Most common adverse events (AEs; ≥30%) were: diarrhea and nausea (59.1% each), vomiting (50.0%) and increased alanine aminotransferase (31.8%). Most common grade ≥3 AEs (≥10%): hyperglycemia (18.2%), increased gamma-glutamyl transferase, thrombocytopenia, and anemia (13.6% each). Clinical trial information: NCT02465528 . Conclusions: Ceritinib 750 mg/day under fasted conditions showed antitumor activity in pts with ALK+ ALCL and IMT; however, data interpretation is limited due to the small sample size. Safety findings were consistent with the known ceritinib safety profile. [Table: see text]

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Obsessive-Compulsive Disorder: An Open-Label Pilot Trial of Escitalopram

CNS Spectrums ◽

10.1017/s1092852900021258 ◽

2007 ◽

Vol 12 (7) ◽

pp. 519-524 ◽

Cited By ~ 10

Author(s):

Amanda Galvão-de Almeida ◽

Lucas C. Quarantini ◽

Cristianne R. Góis ◽

Rogério Santos-Jesus ◽

Ângela M.A. Miranda-Scippa ◽

...

Keyword(s):

Treatment Response ◽

Obsessive Compulsive Disorder ◽

Selective Serotonin Reuptake Inhibitors ◽

Small Sample Size ◽

Pilot Trial ◽

Small Sample ◽

Obsessive Compulsive ◽

Open Label ◽

Compulsive Disorder ◽

Axis I

ABSTRACTIntroduction: Selective serotonin reuptake inhibitors are considered the most effective and well-established pharmacotherapy for the treatment of obsessive-compulsive disorder (OCD), a chronic and disabling condition. However, ~40% of patients do not have a significant improvement, suggesting that new medications are needed. This study was designed to investigate the treatment response to escitalopram in OCD patients.Methods: This open-label study involved 11 adult OCD outpatients diagnosed with the Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Axis I Disorders. Data were collected and the treatment response was assessed by an experienced psychiatrist by using the Yale-Brown Obsessive-Compulsive Scale. Subjects received escitalopram 30 mg/day for 12 weeks starting at 10 mg/day. Dosage adjustments were made within 2 weeks, depending on the tolerability of the patient.Results: Six of the 11 patients (54.5%) presented a reduction of at least 40% in the baseline total Yale-Brown Obsessive-Compulsive Scale scores.Conclusion: Despite the small sample size and the open-label nature of this trial, these data suggest that escitalopram may be a useful option for patients with OCD.

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DOP75 Efficacy of tofacitinib dose escalation to 10 mg BID in patients with UC after completing maintenance therapy in remission and losing response: Data from OCTAVE open-label, long-term extension study

Journal of Crohn s and Colitis ◽

10.1093/ecco-jcc/jjz203.114 ◽

2020 ◽

Vol 14 (Supplement_1) ◽

pp. S112-S113 ◽

Cited By ~ 1

Author(s):

D T Rubin ◽

M C Dubinsky ◽

J Panés ◽

D C Wu ◽

N Lawendy ◽

...

Keyword(s):

Dose Escalation ◽

Small Sample Size ◽

Mucosal Healing ◽

Small Sample ◽

Extension Study ◽

Open Label ◽

Post Dose ◽

Mayo Score ◽

Kaplan Meier

Abstract Background Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). The efficacy and safety of tofacitinib were demonstrated in patients with moderate to severe UC in three Phase 3 studies.1 Here, we investigated outcomes in a subpopulation of the ongoing, open-label, long-term extension study (OLE) (OCTAVE Open; NCT01470612; May 2019; database not locked), including maintenance of remission patients receiving tofacitinib 5 mg twice daily (BID) who were dose-escalated to 10 mg BID due to flare. Methods Analysis included the maintenance remission–dose-escalation subpopulation: patients who achieved remission at Week 52 in OCTAVE Sustain (tofacitinib 5 or 10 mg BID, or placebo), entered OLE (5 mg BID), but were dose-escalated to 10 mg BID due to flare (based on total Mayo score [MS]; local read endoscopy). Remission: total MS ≤2 with no subscore >1, and rectal bleeding (RB) subscore 0. Dose escalation during OLE was permitted if patients experienced a flare, defined as ≥3 increase from maintenance study baseline total MS and ≥1 increase in RB and endoscopic subscore (ES; unless ES=3 at baseline and remained 3) after ≥8 weeks of treatment in OLE. Kaplan–Meier for estimation of time to dose escalation was assessed in all OLE maintenance remission population relative to OLE baseline. Partial MS remission (≤2 with no subscore >1; no ES) assessed at Months (M)3, 6, 9 and 12 post-dose-escalation; mucosal healing (MH; ES ≤1) and remission assessed at M12 post-dose-escalation. Adverse events (AEs) also assessed. Results Of the 944 patients enrolled in OLE, 162 were in remission at baseline and received tofacitinib 5 mg BID, and 41 were dose-escalated to 10 mg BID due to flare (22 had prior TNFi failure). The cumulative proportion of patients with dose escalation was 4.3%, 10.6%, 12.6% and 13.2% at M3, 6, 9 and 12 of OLE, respectively. Partial MS remission was 75.0% at M3, and partial MS remission, MH and remission were 95.0%, 63.6% and 57.6%, respectively, at M12 post-dose escalation (Table). One case each of serious infection, herpes zoster (non-serious; opportunistic infection) and malignancy were reported (see Table). Conclusion For patients with moderate to severe UC who entered OLE in remission, received tofacitinib 5 mg BID but flared and were dose-escalated to 10 mg BID, response was recaptured for most by M3 post-dose-escalation and remission was recaptured in the majority by M12. Safety in this subpopulation was generally consistent with that observed in the overall tofacitinib UC programme.2 Due to the small sample size and open-label nature, results should be interpreted with caution. References

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Paliperidone in the treatment of delirium: results of a prospective open-label pilot trial

Acta Neuropsychiatrica ◽

10.1111/j.1601-5215.2011.00568.x ◽

2011 ◽

Vol 23 (4) ◽

pp. 179-183 ◽

Cited By ~ 8

Author(s):

Ho-Kyoung Yoon ◽

Yong-Ku Kim ◽

Changsu Han ◽

Young-Hoon Ko ◽

Heon-Jeong Lee ◽

...

Keyword(s):

Adverse Effects ◽

Rating Scale ◽

Small Sample Size ◽

Pilot Trial ◽

Small Sample ◽

Open Label ◽

Open Label Study ◽

Label Study ◽

Before And After ◽

The Status

Yoon H-K, Kim Y-K, Han C, Ko Y-H, Lee H-J, Kwon D-Y, Kim L. Paliperidone in the treatment of delirium: results of a prospective open-label pilot trial.Objective: Delirium is a life-threatening neuropsychiatric syndrome characterised by disturbances in consciousness, attention, cognition and perception. Antipsychotics are considered the drugs of choice in managing the symptoms of delirium. Paliperidone is a benzisoxazole derivative and the principal active metabolite of risperidone. In this study, we aimed to evaluate the efficacy of paliperidone for the treatment of delirium.Methods: A prospective open-label study of paliperidone for delirium treatment was performed with 6-day follow-up. Fifteen patients who met Diagnostic and Statistical Manual of Mental disorders, Fourth Edition criteria for delirium and had a score of 13 on the Delirium Rating Scale were recruited. The starting dose was 3 mg once a day and the dose was adjusted depending on the status of delirium. Daily assessments of the severity of delirium were evaluated using Memorial Delirium Assessment Scale (MDAS).Results: The mean daily maintenance dose of paliperidone was 3.75 ± 1.06. The MDAS scores before and after treatment (day 7) were 23.60 ± 6.31 and 11.33 ± 5.45 (t = 6.78, p < 0.001), respectively. The intensity of delirium showed a statistically significant reduction in MDAS scores from the first day of treatment. No serious adverse effects were observed, and none of the patients discontinued paliperidone because of adverse effects.Conclusions: This study shows that low-dose paliperidone is effective in reducing behavioural disturbances and symptoms in delirium and is well tolerated in delirious patients. This trial is an open-label study with a small sample size, and further controlled studies will be necessary.

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