scholarly journals Double-Blinded Randomized Pilot Clinical Trial Comparing Cognitive Side Effects of Standard Ultra-Brief Right Unilateral ECT to 0.5 A Low Amplitude Seizure Therapy (LAP-ST)

2020 ◽  
Vol 10 (12) ◽  
pp. 979
Author(s):  
Nagy A. Youssef ◽  
William V. McCall ◽  
Dheeraj Ravilla ◽  
Laryssa McCloud ◽  
Peter B. Rosenquist
Keyword(s):  
Clinical Trial ◽  
Side Effects ◽  
Rating Scale ◽  
Small Sample Size ◽  
Bipolar Disorders ◽  
Small Sample ◽  
Treatment Groups ◽  
Double Blinded ◽  
Low Amplitude ◽  
Cognitive Side Effects

Background: Concerns over cognitive side effects (CSE) of electroconvulsive therapy (ECT) still limit its broader usage for treatment-resistant depression (TRD). The objectives of this study were to (1) examine the CSE of Low Amplitude Seizure Therapy (LAP-ST) at 0.5 A compared to Ultra-brief Right Unilateral (UB-RUL) ECT using Time to Reorientation (TRO) as the main acute primary outcome, and (2) to compare effects on depressive symptoms between the two treatment groups. Methods: Participants were referred for ECT, consented for the study, and were randomized to a course of LAP-ST or standard UB-RUL ECT. TRO and depression were measured by the Montgomery-Åsberg Depression Rating Scale (MADRS). Results: Eleven patients consented. Of these, eight with a current major depressive episode (MDE) of unipolar or bipolar disorders were randomized. TRO was faster for the LAP-ST (mean = 6.8 min; SE = 4.9) than standard RUL ECT (mean = 15.5 min; SE = 6.5). Depression improved similarly in the two arms of the study from baseline (MADRS: LAP-ST = 41.0; SE = 2.0, RUL = 39.0; SE = 3.8) to endpoint (MADRS score: LAP-ST = 8.0; SE7.2, RUL = 9.5; SE = 3.8). Conclusions: This pilot, randomized and blinded clinical trial, suggests that the LAP-ST (at 0.5 A) has faster reorientation and possibly lower CSE compared to standard RUL-UB ECT. Caution is advised in interpreting these results due to the small sample size of this pilot study. Thus, future studies with similar design are warranted for replicating these findings.

scholarly journals Magnitude of Reduction and Speed of Remission of Suicidality for Low Amplitude Seizure Therapy (LAP-ST) Compared to Standard Right Unilateral Electroconvulsive Therapy: A Pilot Double-Blinded Randomized Clinical Trial

2019 ◽  
Vol 9 (5) ◽  
pp. 99 ◽  
Author(s):  
Nagy A. Youssef ◽  
Dheeraj Ravilla ◽  
Cherishma Patel ◽  
Mark Yassa ◽  
Ramses Sadek ◽  
...  
Keyword(s):  
Side Effects ◽  
Electroconvulsive Therapy ◽  
Rating Scale ◽  
Treatment Guidelines ◽  
Descriptive Analysis ◽  
A Priori ◽  
Bipolar Disorders ◽  
Double Blinded ◽  
Low Amplitude ◽  
Cognitive Side Effects

Background: Although treatment guidelines support use of electroconvulsive therapy (ECT) for acute suicidality, it is associated with cognitive side effects. The effect of Low Amplitude Seizure Therapy (LAP-ST) on suicidality is unknown. Our prior precision LAP-ST (pLAP-ST) performing titrating in the current domain has provided initial proof of concept data in humans of its advantage in terms of reduction of cognitive side effects. The aims of this report are to: 1) compare LAP-ST (at 500mA) versus standard Right Unilateral (RUL) ECT (at 900 mA) in terms of magnitude of remission of suicidality in a randomized allocation and 2) compare the speed of remission of suicidality between LAP-ST versus RUL ECT. Methods: Patients were randomized to either LAP-ST or RUL ECT. The scores pertaining to the suicidal ideation (SI) item on the Montgomery-Åsberg Depression Rating Scale (MADRS) were analyzed using descriptive analysis and no confirmatory statistical analysis was performed due to a priori sample size limitations for this pilot study. SI item remission was defined as 2 or below on this item. Results: Eleven patients with major depressive episode (MDE) of mainly unipolar or bipolar disorders signed consent. Of these, 7 were eligible and were randomized and included in the analysis; all were actively suicidal at baseline (suicide item above 2), except 1 patient who had suicide item at 2 in the RUL ECT group. Suicidality remitted on average by session 3 and remission occurred for all patients by session 4. The SI mean score improvement from baseline to endpoint for LAP-ST was 5.1 and for RUL ECT was 3.0. Conclusions: LAP-ST has larger effect size and speed of remission of suicidality compared to standard RUL ECT. Future studies are warranted for replicating these findings. (ClinicalTrials.gov ID: NCT02583490).

scholarly journals Topiramate reduces nocturnal eating in sleep-related eating disorder

SLEEP ◽  
2020 ◽  
Vol 43 (9) ◽  
Author(s):  
John W Winkelman ◽  
Benjamin Wipper ◽  
Julia Purks ◽  
Leslie Mei ◽  
Laura Schoerning
Keyword(s):  
Clinical Trial ◽  
Eating Disorder ◽  
Side Effects ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Case Series ◽  
Study Groups ◽  
Small Sample ◽  
Drop Out ◽  
Intention To Treat

Abstract Study Objectives Sleep-related eating disorder (SRED) is a parasomnia characterized by partial arousals from sleep with compulsive consumption of food with impaired level of awareness and memory for the event. Small case series’ have demonstrated efficacy of topiramate in SRED. We conducted a placebo-controlled randomized clinical trial of topiramate to assess efficacy in SRED. Methods Thirty-four participants with an ICSD-2/ICSD-3 diagnosis of SRED with >6 months of symptoms and ≥3 sleep-related eating episodes per week were randomized to placebo or topiramate with flexible dosing to a maximum dosage of 300 mg for 13 weeks. Primary outcomes were percentage of nights with eating and Clinician Global Impression-Improvement (CGI-I). Intention-to-treat last observation carried forward (ITT LOCF) analysis was conducted. Results Mean age was 39.5 years, 74% were female, with mean duration of sleep-related eating of 13.7 years. SRED symptoms were significantly reduced with topiramate (74.7% to 33.2% nights/week; n = 15) compared to placebo (77.0% to 57.4%; n = 17) (p = 0.035). There were significantly more CGI-I responders on topiramate (71%) than placebo (27%) (p = 0.016). Level of wakefulness (r = −0.49) and memory for nighttime eating (r = −0.58) at baseline predicted topiramate response. The topiramate group lost significantly more weight than the placebo group (−8.5 lbs vs. +1.0 lbs, p = 0.001). The most common side effects were paresthesias and cognitive dysfunction. Conclusions This first randomized controlled trial demonstrating efficacy for treatment of SRED supports preliminary data on the use of topiramate for SRED. Side effects were prominent for topiramate. Limitations include a small sample size and a high drop-out rate in both study groups. Clinical Trial Information NCT00606411

Valpromide increases amplitude of heart rate circadian rhythm in remitted bipolar and unipolar disorders.A placebo-controlled study

2000 ◽  
Vol 15 (7) ◽  
pp. 424-432 ◽  
Author(s):  
P Lemoine ◽  
J Fondarai ◽  
T Faivre
Keyword(s):  
Heart Rate ◽  
Circadian Rhythm ◽  
Rating Scale ◽  
Small Sample Size ◽  
Bipolar Disorders ◽  
Small Sample ◽  
Sleep Diary ◽  
Controlled Study ◽  
Double Blind ◽  
Sleep Study

The aim of this study was to investigate for the effects of valpromide on heart rate circadian rhythm in remitted recurrent unipolar and bipolar disorders (DSM-III-R). It consisted of a comparative, randomized, double-blind, repeated cross-over study of valpromide versus placebo over four four-week periods. The primary evaluation criteria was heart rate (HR). Secondary criteria comprised motor activity (MA) and the Bech and Rafaelsen mania assessment scale, Horne and Ostberg questionnaire, Montgomery and Asberg depression rating scale, Spiegel questionnaire, a sleep diary, and Clinical Global Impression. Fifteen patients were included, giving 60 one-month periods (30 valpromide periods and 30 placebo periods).Cosinor analysis of HR and MA data revealed a difference in amplitude (P = 0.037, analysis of variance, one-tailed test).The clinical sleep study shows that the duration of sleep was greater with valpromide than with placebo (P = 0.007, one-tailed test). Similarly, evaluation of the quality of sleep by patients themselves showed valpromide to be superior to placebo (P = 0.045, one-tailed test). The results of analysis of the Spiegel questionnaire also confirm the superiority of valpromide over placebo. Safety and compliance were comparable for the active drug and the placebo.In conclusion, the relatively small sample size requires cautious interpretation of this study. Nevertheless, these initial results show a definite effect of valpromide on a biological rhythm that leads one to suppose that it may be effective through a ‘synchronizing’ effect.

scholarly journals Responsiveness of the Scripps Neurologic Rating Scale During a Multiple Sclerosis Clinical Trial

1999 ◽  
Vol 26 (4) ◽  
pp. 283-289 ◽  
Author(s):  
James A. Koziol ◽  
Adriana Lucero ◽  
Jack C. Sipe ◽  
John S. Romine ◽  
Ernest Beutler
Keyword(s):  
Multiple Sclerosis ◽  
Clinical Trial ◽  
Rating Scale ◽  
Effect Sizes ◽  
Active Therapy ◽  
Double Blind ◽  
Treatment Groups ◽  
Negative Effect ◽  
The Individual ◽  
Positive Effect

Objective:The Scripps neurologic rating scale (SNRS) is a summary measure of individual components comprising a neurological examination, designed for use in multiple sclerosis (MS). Our objective is to evaluate the responsiveness of the SNRS, within the context of a 2-year, randomized, double-blind crossover study of the efficacy of cladribine for treatment of secondary progressive MS.Methods:Effect sizes were determined for the SNRS and its components, separately for each treatment group (initial placebo, and initial cladribine) over both years of the clinical trial, using a standard random effects model.Results:Individual components tended to show positive effect sizes (improvement) during periods of active therapy in both treatment groups, and negative effect sizes (deterioration) during periods of no active therapy. Summation indices derived from the individual components of the SNRS seemed somewhat more stable than the individual components. The two components mentation and mood, and bladder, bowel, or sexual dysfunction, were rather unresponsive in our clinical trial.Conclusion:Changes in the components of the SNRS over the course of our clinical trial were consistent between the two treatment groups. Most components were moderately responsive; and, the summary SNRS score appropriately summarized the moderate magnitudes of change evinced in the individual components.

Abstract 3725: Simvastatin but Not Pravastatin Affects Sleep: Findings from the UCSD Statin Study

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Beatrice A Golomb ◽  
Edwin K Kwon ◽  
Michael H Criqui ◽  
Joel E Dimsdale
Keyword(s):  
Sleep Quality ◽  
Rating Scale ◽  
Sleep Problems ◽  
Small Sample Size ◽  
Case Reports ◽  
Controlled Trial ◽  
Small Sample ◽  
T Test ◽  
Secondary Outcome ◽  
Regression Analyses

Background : Case reports have suggested possible effects of lipophilic statins on sleep in some subjects. Most randomized studies evaluating the effect of statins on sleep have had small sample size and short duration (≤ 6 weeks). Whether statins affect sleep on average, favorably or adversely, has been unclear. Goal : To assess the effects of lipophilic and hydrophilic statins on sleep. Subjects : 1016 adult men and women without diabetes or heart disease, with LDL-cholesterol 115–190mg/dL. Design : Randomized double blind placebo-controlled trial of simvastatin 20mg, pravastatin 40mg or placebo for 6 months. Sleep was a prespecified secondary outcome. It was assessed by both an adaptation of the Leeds sleep scale (a visual analog scale of sleep quality); and a rating scale of sleep problems. Both items were measured at baseline and on-treatment. Analysis : Baseline comparability of randomization groups including sleep measures was affirmed. T-test of mean on-treatment sleep scores across randomization groups was performed. This complemented regression analyses, adjusted for baseline values of the respective sleep assessment. Results : Groups were comparable at baseline on variables including both sleep measures. Simvastatin use was associated with significantly worse sleep quality, and significantly greater reported sleep problems than either pravastatin or placebo, by t-test and regression analyses. Pravastatin did not differ significantly from placebo on any sleep outcome. Conclusion : Findings were compatible with the hypothesis that statins may impair sleep in some subjects, and that this impairment may arise selectively with lipophilic statins. Table 1. Effects of Statins on Sleep: Regression Analysis

Lidocaine Adrenaline Tetracaine Gel Versus Tetracaine Adrenaline Cocaine Gel for Topical Anesthesia in Linear Scalp and Facial Lacerations in Children Aged 5 to 17 Years

PEDIATRICS ◽  
1995 ◽  
Vol 95 (2) ◽  
pp. 255-258 ◽  
Author(s):  
Amy A Ernst ◽  
Eduardo Marvez ◽  
Todd G. Nick ◽  
Eric Chin ◽  
Edmond Wood ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Emergency Department ◽  
Inner City ◽  
Rating Scale ◽  
Topical Anesthesia ◽  
Random Numbers ◽  
Study Objective ◽  
The Face ◽  
Double Blinded

Study objective. The purpose of the present study is to compare LAT gel (4% lidocaine, 1:2000 adrenaline, 0.5% tetracaine) to TAC gel (0.5% tetracaine, 1:2000 adrenaline, 11.8% cocaine) for efficacy, side effects, and costs in children aged 5 to 17 years with facial or scalp lacerations. Design. Randomized, prospective, double-blinded clinical trial. Setting. Inner-city Emergency Department with an Emergency Medicine residency program. Patients or other participants. Children aged 5 to 17 years with linear lacerations of the face or scalp. Intervention. After informed consent was obtained patients had lacerations anesthetized with topical TAC or LAT gel according to a random numbers table. Measurements and main results. A total of 95 patients were included in the statistical analysis with 47 receiving TAC and 48 receiving LAT. Physicians and patients/parents separately rated the overall pain of suturing using a modified multidimensional scale for pain assessment specifically for children. Patients/parents also stated the number of sutures causing pain. The power of the study to determine a ranked sum difference of 15 was 0.8. Multidimensional rating scale results and number and percentage of sutures causing pain were compared using Wilcoxon's rank sum test. According to patients no difference could be detected in percent of sutures causing pain in the LAT versus TAC group (P = .51). Using the multidimensional scale, physicians and patients/parents found LAT statistically the same as TAC in effectiveness (P = .80 for physicians and P = .71 for patients). Cost per application was $3.00 for LAT compared to $35.00 for TAC. Follow-up was accomplished in 85 of 95 participants in the study with no reported complications for either medication. Conclusion. LAT gel worked as well as TAC gel for topical anesthesia in facial and scalp lacerations. Considering the advantages of a noncontrolled substance and less expense, LAT gel appears to be better suited than TAC gel for topical anesthesia in laceration repair in children.

A Comparative Trial of Opipramol and Chlordiazepoxide in the Treatment of Anxiety

1973 ◽  
Vol 1 (3) ◽  
pp. 145-150 ◽  
Author(s):  
K Jepson ◽  
G Beaumont
Keyword(s):  
Clinical Trial ◽  
General Practice ◽  
Side Effects ◽  
Rating Scale ◽  
Comparative Trial ◽  
Anxiety Score ◽  
Double Blind ◽  
Somatic Anxiety ◽  
Daily Dose ◽  
The Difference

A daily dose of 200 mg of opipramol (Insidon, Geigy) and 30 mg of chlordiazepoxide (Librium, Roche) were compared in a clinical trial in general practice. The trial was double blind and a stratified randomisation technique was employed. Twenty four patients received opipramol and twenty six chlordiazepoxide for four weeks. A total anxiety score and separate ‘psychic’ anxiety and ‘somatic’ anxiety scores were recorded, using a rating scale initially and after two and four weeks treatment. No overall difference in efficacy was found between the two drugs—opipramol producing a 76% improvement and chlordiazepoxide 64% by the end of the study. There was no difference in the relief of psychic anxiety. Although opipramol appeared to give more relief of somatic anxiety, the difference was not statistically significant. Again although opipramol relieved more individual symptoms than chlordiazepoxide, none of the differences were significant. 70% of patients on opipramol and 74% of those on chlordiazepoxide were classified ‘better’ globally by both doctor and patient by the end of the trial. The total number of side effects recorded was similar on both drugs although drowsiness occurred twice as frequently on chlordiazepoxide as it did on opipramol.

A Pilot Randomized Sham-Controlled Trial of MC5-A Scrambler Therapy in the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy (CIPN)

2019 ◽  
Vol 35 (1) ◽  
pp. 53-58 ◽  
Author(s):  
Thomas J. Smith ◽  
A. Rab Razzak ◽  
Amanda L. Blackford ◽  
Jennifer Ensminger ◽  
Catherine Saiki ◽  
...  
Keyword(s):  
Peripheral Neuropathy ◽  
Rating Scale ◽  
Small Sample Size ◽  
Controlled Trial ◽  
Brief Pain Inventory ◽  
Small Sample ◽  
Sham Treatment ◽  
The Real ◽  
Average Pain ◽  
Scrambler Therapy

Background: Chemotherapy-induced peripheral neuropathy (CIPN) affects 30% to 40% of patients with cancer with long-lasting disability. Scrambler therapy (ST) appeared to benefit patients in uncontrolled trials, so we performed a randomized sham-controlled Phase II trial of ST. Methods: The primary end point was “average pain” after 28 days on the Numeric Rating Scale. Each received ten 30-minute sessions of ST on the dermatomes above the painful areas, or sham treatment on the back, typically at L3-5 where the nerve roots would enter the spinal cord. Outcomes included the Brief Pain Inventory (BPI)-CIPN and the EORTC CIPN-20 scale. Patients were evaluated before treatment (day 0), day 10, and days 28, 60, and 90. Results: Data regarding pain as a primary outcome were collected for 33 of the 35 patients. There were no significant differences between the sham and the “real” ST group at day 10, 28, 60, or 90, for average pain, the BPI, or EORTC CIPN-20. Individual responses were noted during the ST treatment on the real arm, but most dissipated by day 30. There was improvement in the sensory subscale of the CIPN-20 at 2 months in the “real” group ( P = .14). All “real” patients wanted to continue treatment if available. Discussion: We observed no difference between sham and real ST CIPN treatment. Potential reasons include at least the following: ST does not work; the sham treatment had some effect; small sample size with heterogeneous patients; misplaced electrodes on an area of nonpainful but damaged nerves; or a combination of these factors.

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