Early predictors of two month response with mianserin and selective serotonin reuptake inhibitors and influence of definition of outcome on prediction

1998 ◽  
Vol 13 (3) ◽  
pp. 138-142 ◽  
Author(s):  
I Berlin ◽  
F Lavergne
Keyword(s):  
Complete Remission ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Stepwise Logistic Regression ◽  
Stepwise Logistic Regression Analysis ◽  
Double Blind ◽  
Significant Treatment ◽  
Early Improvement ◽  
Time Interaction ◽  
Early Predictors ◽  
Definition Of

SummaryIn order to identify clinical and demographic variables that predict response to antidepressants and to analyse prediction of outcome as a function of definition of outcome we analysed pooled data of two independent, multicentre, double blind parallel group studies. Study I compared the efficacy of mianserin with that of fluoxetine in 65, and study II compared mianserin with fluvoxamine in 60 patients with depression. Improvement was defined as at least 20% decrease in MADRS by day 14. Patients were considered as responders if they had greater than 50% decrease and non-responders if they had ≤ 50% decrease from baseline in the MADRS at day 56. Complete remission was defined as MADRS score ≤ 6 at day 56. Patients' characteristics did not differ between mianserin and SSRI groups. Early improvement predicted response in 92% and complete remission in 55% of the patients improved at day 14. Multivariate forward stepwise logistic regression analysis showed that response to treatments at day 56 was significantly (P = 0.0003) associated with early improvement, age (responders had higher age than non-responders) and weight (responders weighted more than non-responders). Complete remission was only predicted by early improvement. Treatments could not be differentiated when data were analysed according to responder/nonresponder status or complete remission/no complete remission. However, when the same data were analysed by analysis of variance a significant treatment effect (P = 0.02, mianserin > SSRIs) and a quadratic type treatment by time interaction (P = 0.023) were found. The robustness of the analysis was further improved by inclusion of covariates (age, weight). Early clinical improvement seems to be the best predictor of 2 month response to antidepressants (mianserin, SSRIs). Younger age and lower weight may predict non-response. Quantitative analysis differentiates treatments better than analysis of responder status. As obtenation of complete remission is a realistic objective with current antidepressants, studies longer than 2 months are needed to assess effectiveness of these drugs in the obtenation of complete remission.

scholarly journals Inulin-type fructan intervention restricts the increase in gut microbiome–generated indole in patients with peritoneal dialysis: a randomized crossover study

2020 ◽  
Vol 111 (5) ◽  
pp. 1087-1099 ◽  
Author(s):  
Li Li ◽  
Qingqing Xiong ◽  
Jing Zhao ◽  
Xuechun Lin ◽  
Shuiqin He ◽  
...  
Keyword(s):  
Peritoneal Dialysis ◽  
Gut Microbiome ◽  
Treatment Time ◽  
Double Blind ◽  
Significant Treatment ◽  
Time Interaction ◽  
The Difference ◽  
Fecal Ph ◽  
Stage Renal Disease ◽  
End Stage

ABSTRACT Background Indoxyl sulfate (IS) and p-cresyl sulfate (pCS), 2 important protein-bound uremic toxins, are independent risk factors for cardiovascular disease in patients with end-stage renal disease. Indole and p-cresol are gut microbiome–generated precursors of IS and pCS. Objective The aim of the present study was to determine whether inulin-type fructans (ITFs) reduce the production of indole and p-cresol by altering their producing bacteria in patients with peritoneal dialysis. Methods Patients receiving peritoneal dialysis for >3 mo without diabetes and not using antibiotics were recruited to a randomized, double-blind, placebo-controlled, crossover trial of ITF intervention over 36 wk (12-wk washout). The primary outcomes were gut microbiome, fecal indole and p-cresol, indole-producing bacteria, p-cresol-producing bacteria, and serum IS and pCS. The secondary outcomes were fecal pH, 24-h urine, and dialysis removal of IS and pCS. Results Of 21 individuals randomly assigned, 15 completed the study. The daily nutrient intakes, including protein, tryptophan, and tyrosine, were isostatic during the prebiotic, washout, and placebo intervention. There were no baseline differences in the outcomes of interest between treatments. For fecal indole, its concentrations did not change significantly in either treatment. However, there was a trend toward the treatment-by-time effect (P = 0.052), with a quantitative reduction in the ITF treatment and an increase in the control. The difference in the changes between the 2 treatments was significant (−10.07 ± 7.48 μg/g vs +13.35 ± 7.66 μg/g; P = 0.040). Similar to Bacteroides thetaiotaomicron, there was a difference over time between the 2 treatments, with a significant treatment and time interaction effect (P = 0.047). There were no treatment, time, or interaction effects for fecal p-cresol, serum IS and pCS, 24-h urine, and dialysis removal of IS and pCS. Conclusions Our results suggested that ITFs restricted the increase in gut microbiome–generated indole in patients with peritoneal dialysis. This trial was registered at http://www.chictr.org.cn/showproj.aspx?proj=21228 as ChiCTR-INR-17013739.

scholarly journals Rapamycin, an Immunosuppressant and mTORC1 Inhibitor, Triples the antidepressant Response Rate of Ketamine at 2 Weeks Following Treatment: A double-blind, placebo-controlled, cross-over, randomized clinical trial

2018 ◽  
Author(s):  
Chadi Abdallah ◽  
Lynnette A Averill ◽  
Ralitza Gueorguieva ◽  
Selin Goktas ◽  
Prerana Purohit ◽  
...  
Keyword(s):  
Rating Scale ◽  
Response Rate ◽  
Acute Effects ◽  
Antidepressant Response ◽  
Double Blind ◽  
Significant Treatment ◽  
Time Interaction ◽  
Antidepressant Effects

BACKGROUND: Ketamine exerts rapid and robust antidepressant effects thought to be mediated by activation of the mechanistic target of rapamycin complex 1 (mTORC1). To test this hypothesis, depressed patients were pretreated with rapamycin, an mTORC1 inhibitor, prior to receiving ketamine. METHODS: Twenty-three patients suffering a major depressive episode were randomized to oral rapamycin (6 mg) or placebo, each was followed 2 hours later by ketamine 0.5 mg/kg in a double-blind cross-over design with treatment days separated by at least 2 weeks. Depression severity was assessed using Montgomery Asberg Depression Rating Scale (MADRS). Antidepressant response was defined as a MADRS improvement of 50% or more. RESULTS: Over the two-week follow-up, we found a significant treatment by time interaction (F(8,245) = 2.02, p = 0.04), reflecting prolonged antidepressant effects post rapamycin+ketamine treatment. At 2 weeks, we found a significantly higher response rate following rapamycin+ketamine (41%) compared to placebo+ketamine (13%, p = 0.04). However, rapamycin pretreatment did not alter the acute effects of ketamine. CONCLUSION: Unexpectedly, pretreatment with rapamycin prolonged rather than blocked the acute antidepressant effects of ketamine. This observation raises questions about the role of mTORC1 in the antidepressant effects of ketamine, raises the possibility that rapamycin may extend the benefits of ketamine, and thereby potentially sheds light on mechanisms that limit the duration of ketamine effects. The supplementing of ketamine with rapamycin may be a treatment strategy for reducing the frequency of ketamine infusions during maintenance treatment.

Randomized, Double-Blind, Placebo-Controlled Trial of Epoetin Alfa (Procrit) in Patients with Rectal and Gastric Cancer Undergoing Chemo-Radiotherapy (CT/RT) Followed by Surgery: Early Termination of the Trial Due to Increased Incidence of Thrombo-Embolic Events (TEE).

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 2915-2915 ◽  
Author(s):  
Saroj Vadhan-Raj ◽  
John M. Skibber ◽  
Christopher Crane ◽  
Carlos E. Bueso-Ramos ◽  
Miguel A. Rodriguez-Bigas ◽  
...  
Keyword(s):  
Treatment Outcome ◽  
Controlled Trial ◽  
Tumor Hypoxia ◽  
Complete Response ◽  
Red Cell ◽  
Double Blind ◽  
Significant Treatment ◽  
Treatment Groups ◽  
Time Interaction ◽  
Increased Risk

Abstract Patients with resectable gastric and rectal cancer undergoing CT/RT followed by surgery are at increased risk for anemia, fatigue, and need for red cell transfusions. Anemia and tumor hypoxia may contribute to adverse treatment outcome. A multi-center, placebo-controlled trial of 184 patients was designed to determine if Procrit treatment can maintain Hb (≥13 gm/dL), reduce the need for PRBC Tx and improve treatment outcome. Procrit was administered weekly (40,000 units starting dose) for 16 wks during CT/RT (5 FU or Xeloda + 45 Gy over 5 weeks) followed by surgery. After 60 pts were randomized, the trial was terminated due to increased incidence of TEE. 59 of these pts (53 rectal and 6 gastric) received at least one dose of treatment; 31 in the placebo and 28 in the Procrit group. Baseline median Hb for the study group was 13 gm/dL. Seven (11.9%) pts experienced venous TEE; 1/31 (3.2%) pts treated with placebo compared with 6/28 (21.4%) pts treated with Procrit (p= 0.045). In exploratory analyses including the multivariate modeling, it was observed that the Procrit treatment was a predictor of TEE (p = 0.060), however this was not observed for Hb (p = 0.998). Using a mixed-effects model, Hb was significantly higher in pts treated with Procrit than pts treated with placebo (p = 0.0004) during CT/RT. In addition, Hb was significantly different across weeks (p < 0.0001). During the study period, there was also a significant treatment by time interaction (p = 0.0061) with Hb maintained/increased in Procrit pts while it steadily decreased in the placebo pts. Four (14.3%) pts treated with Procrit compared with 10 (32.3%) pts treated with placebo required red cell transfusions (p = 0.133). Platelets (PLTs) decreased significantly from baseline during CT/RT (at weeks 4) for the placebo pts and for the pts treated with Procrit who did not experience TEE (p < 0.0001), but there was a trend for an increase in PLT in pts who experienced TEE. The tumor response for rectal ca at MDACC site was similar between both treatment groups with 14/22 (63.6%) in each treatment group (p = 0.777). These findings indicate that treatment with Procrit may prevent anemia during CT/RT/surgery, however there is increased risk for TEE in this setting for prevention of anemia. Correlative analysis is ongoing on biomarkers and molecular markers on biopsy specimens to examine the markers predictive of pathological complete response, TEE, and the treatment outcome.

scholarly journals Remission rates during treatment with venlafaxine or selective serotonin reuptake inhibitors

2001 ◽  
Vol 178 (3) ◽  
pp. 234-241 ◽  
Author(s):  
Michael E. Thase ◽  
A. Richard Entsuah ◽  
Richard L. Rudolph
Keyword(s):  
Serotonin Reuptake ◽  
Selective Serotonin Reuptake Inhibitors ◽  
Rating Scale ◽  
Depression Score ◽  
Serotonin Reuptake Inhibitors ◽  
Selective Serotonin ◽  
Double Blind ◽  
Remission Rates ◽  
The Difference ◽  
Definition Of

BackgroundIt had been suggested that the antidepressant venlafaxine, which inhibits reuptake of both serotonin and (at higher doses) noradrenaline, may result in better outcomes than treatment with selective serotonin reuptake inhibitors (SSRIs).AimsTo compare remission rates during treatment with SSRIs or venlafaxine.MethodData from eight comparable randomised, double-blind studies of major depressive disorder were pooled to compare remission rates (Hamilton Rating Scale for Depression score ≤ 7) during treatment with venlafaxine (n=851), SSRIs (fluoxetine, paroxetine, fluvoxamine; n=748) or placebo (four studies; n=446).ResultsRemission rates were: venlafaxine, 45% (382/851); SSRIs, 35% (260/748); placebo, 25% (110/446) (P < 0.001; odds ratio for remission is 1.50 (1.3–1.9), favouring venlafaxine v. SSRIs). The difference between venlafaxine and the SSRIs was significant at week 2, whereas the difference between SSRIs and placebo reached significance at week 4. Results were not dependent on any one study or the definition of remission.ConclusionsRemission rates were significantly higher with venlafaxine than with an SSRI.

scholarly journals Pseudoephedrine Ingestion and Cycling Time-Trial Performance

2010 ◽  
Vol 20 (2) ◽  
pp. 132-138 ◽  
Author(s):  
Kellie R. Pritchard-Peschek ◽  
David G. Jenkins ◽  
Mark A. Osborne ◽  
Gary J. Slater
Keyword(s):  
Treatment Time ◽  
Venous Blood ◽  
Time Trial ◽  
Double Blind ◽  
Variable Intensity ◽  
Fixed Amount ◽  
Significant Treatment ◽  
Cycling Time Trial ◽  
Time Interaction ◽  
Cycling Time

The aim of the current study was to investigate the effect of 180 mg of pseudoephedrine (PSE) on cycling time-trial (TT) performance. Six well-trained male cyclists and triathletes (age 33 ± 2 yr, mass 81 ± 8 kg, height 182.0 ± 6.7 cm, VO2max 56.8 ± 6.8 ml ⋅ kg−1 ⋅ min−1; M ± SD) underwent 2 performance trials in which they completed a 25-min variable-intensity (50–90% maximal aerobic power) warm-up, followed by a cycling TT in which they completed a fixed amount of work (7 kJ/kg body mass) in the shortest possible time. Sixty minutes before the start of exercise, they orally ingested 180 mg of PSE or a cornstarch placebo (PLA) in a randomized, crossover, double-blind manner. Venous blood was sampled immediately pre- and postexercise for the analysis of pH plus lactate, glucose, and norepinephrine (NE). PSE improved cycling TT performance by 5.1% (95% CI 0–10%) compared with PLA (28:58.9 ± 4:26.5 and 30:31.7 ± 4:36.7 min, respectively). There was a significant Treatment × Time interaction (p = .04) for NE, with NE increasing during the PSE trial only. Similarly, blood glucose also showed a trend (p = .06) for increased levels postexercise in the PSE trial. The ingestion of 180 mg of PSE 60 min before the onset of high-intensity exercise improved cycling TT performance in well-trained athletes. It is possible that changes in metabolism or an increase in central nervous system stimulation is responsible for the observed ergogenic effect of PSE.

The Use of Total Contact Orthoses in Patients with Foot Problems in Foot Clinic, Siriraj Hospital

2020 ◽  
Vol 103 (12) ◽  
pp. 1292-1299
Keyword(s):  
Odds Ratio ◽  
Univariate Analysis ◽  
Stepwise Logistic Regression ◽  
Posterior Tibial Tendon ◽  
Posterior Tibial Tendon Dysfunction ◽  
Stepwise Logistic Regression Analysis ◽  
Cross Sectional ◽  
Siriraj Hospital ◽  
Foot Problems ◽  
Foot Clinic

Objective: To study the use rate, outcome, and concomitant factors of the use of the total contact orthoses (TCO) in the Foot Clinic, Siriraj Hospital Materials and Methods: The present study was a cross-sectional descriptive study collecting data from patient medical records and questionnaires. Patients who had foot problems without impairment of foot sensation and received the TCO from the Foot Clinic between July 2015 and April 2016 were interviewed before and after using the latest TCO for one month. Results: One hundred seven participants were recruited. Most were female (84.1%) with a median age of 59.3 years. The majority had chronic plantar fasciitis (26.2%), posterior tibial tendon dysfunction (PTTD) (25.2%), hallux valgus (21.5%), or metatarsalgia (21.5%). The TCO user was defined as a participant who had to use the TCO for more than three days per week and for more or equal to 50% of daily walking and standing duration. The use rate was 67.3%. The TCO provides standing and walking stability (p=0.008). For patients with metatarsalgia, using the TCO could significantly reduce pain (p=0.002). Using univariate analysis, many factors were found to be associated with the use of the TCO including having level of convenience of putting on or taking off shoes with TCO at 9 or more (odds ratio 2.66, 95% CI 1.16 to 6.12), having difficulty to find proper shoes that fit with the TCO (odds ratio 0.36, 95% CI 0.15 to 0.89), receiving more than one pair of TCO (odds ratio 4.09, 95% CI 1.51 to 11.05), and having level of comfort satisfaction during the TCO use at 9 or more (odds ratio 3.61, 95% CI 1.55 to 8.40). The latter two factors were found to be associated with the use of the TCO from stepwise logistic regression analysis (adjusted odds ratio 3.39, 95% CI 1.18 to 9.71 and 3.02, 95% CI 1.07 to 8.47, respectively). Conclusion: The use of the TCO in the Foot Clinic, Siriraj Hospital was 67.3%. Using the TCO could promote walking stability. Factors affecting the use of the TCO included receiving more than the first pair of TCO and having comfort satisfaction level of 9 or more. Keywords: Use, Total contact orthoses, Total contact insole, Foot problems

Patterns of care in Italian psychiatric services and psychosocial outcome of schizophrenic patients. A three-year prospective study

1989 ◽  
Vol 4 (1) ◽  
pp. 23-31 ◽  
Author(s):  
D. Kemali ◽  
M. Maj ◽  
B. Carpiniello ◽  
R.D. Giurazza ◽  
M. Impagnatiello ◽  
...  
Keyword(s):  
Psychosocial Adjustment ◽  
Ad Hoc ◽  
Social Withdrawal ◽  
Skills Training ◽  
Favourable Outcome ◽  
Stepwise Logistic Regression ◽  
Psychosocial Outcome ◽  
Stepwise Logistic Regression Analysis ◽  
Schizophrenic Patients ◽  
The Difference

Summary141 patients with an ICD-9 diagnosis of schizophrenic psychosis were followed up prospectively for 3 years in 7 Italian centres, representative of the different degrees of application of the psychiatric reform law (Law 180) passed in 1978. It was agreed that each centre would treat the patients according to its routine, and that all contacts with the patients and each intervention performed would be carefully recorded in an ad hoc schedule. The baseline evaluation of psychosocial adjustment was performed by the Disability Assessment Schedule (DAS), and this assessment was then repeated every 6 months during the follow-up period. At the end of this period, the rating on the DAS section 5 was taken as a global measure of patients’ psychosocial outcome. On a stepwise logistic regression analysis, 2 variables were found to be significantly predictive of psychosocial outcome, that is the use of social and/or vocational skills training (associated with a favourable outcome) and the number of days/year of full hospitalization (associated with a poor outcome). Trieste and Arezzo were the only centres in which a significant improvement of the score on some DAS subscales (namely, “occupational role, interest” and “social withdrawal”) was detected. In the whole patient sample, the difference between the final and the baseline score on these subscales correlated significantly with the number/year of outpatient contacts and of home visits. These findings confirm the favourable impact of the community-oriented care provided in some Italian centres on the Psychosocial outcome of schizophrenic patients.

scholarly journals A rapid screening model for early predicting novel coronavirus pneumonia in Zhejiang Province of China: a multicenter study

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Yi-Ning Dai ◽  
Wei Zheng ◽  
Qing-Qing Wu ◽  
Tian-Chen Hui ◽  
Nan-Nan Sun ◽  
...  
Keyword(s):  
Operating Characteristic ◽  
Clinical Manifestations ◽  
Cost Effective ◽  
Rapid Screening ◽  
Stepwise Logistic Regression ◽  
Stepwise Logistic Regression Analysis ◽  
Screening Model ◽  
Epidemiological Features ◽  
Geographical Regions ◽  
Novel Coronavirus

AbstractNovel coronavirus pneumonia (NCP) has been widely spread in China and several other countries. Early finding of this pneumonia from huge numbers of suspects gives clinicians a big challenge. The aim of the study was to develop a rapid screening model for early predicting NCP in a Zhejiang population, as well as its utility in other areas. A total of 880 participants who were initially suspected of NCP from January 17 to February 19 were included. Potential predictors were selected via stepwise logistic regression analysis. The model was established based on epidemiological features, clinical manifestations, white blood cell count, and pulmonary imaging changes, with the area under receiver operating characteristic (AUROC) curve of 0.920. At a cut-off value of 1.0, the model could determine NCP with a sensitivity of 85% and a specificity of 82.3%. We further developed a simplified model by combining the geographical regions and rounding the coefficients, with the AUROC of 0.909, as well as a model without epidemiological factors with the AUROC of 0.859. The study demonstrated that the screening model was a helpful and cost-effective tool for early predicting NCP and had great clinical significance given the high activity of NCP.

scholarly journals Effects of Vitamin D Supplementation on Surrogate Markers of Fertility in PCOS Women: A Randomized Controlled Trial

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 547
Author(s):  
Elisabeth Lerchbaum ◽  
Verena Theiler-Schwetz ◽  
Martina Kollmann ◽  
Monika Wölfler ◽  
Stefan Pilz ◽  
...  
Keyword(s):  
Vitamin D ◽  
Treatment Effect ◽  
Polycystic Ovary ◽  
Controlled Trial ◽  
Dehydroepiandrosterone Sulfate ◽  
Vitamin D Supplementation ◽  
Double Blind ◽  
Significant Treatment ◽  
Hydroxyvitamin D ◽  
Randomized Controlled

Vitamin D (VD) might play an important role in polycystic ovary syndrome (PCOS) and female fertility. However, evidence from randomized controlled trials (RCT) is sparse. We examined VD effects on anti-Müllerian hormone (AMH) and other endocrine markers in PCOS and non-PCOS women. This is a post hoc analysis of a single-center, double-blind RCT conducted between December 2011 and October 2017 at the endocrine outpatient clinic at the Medical University of Graz, Austria. We included 180 PCOS women and 150 non-PCOS women with serum 25-hydroxyvitamin D (25(OH)D) concentrations <75 nmol/L in the trial. We randomized subjects to receive 20,000 IU of VD3/week (119 PCOS, 99 non-PCOS women) or placebo (61 PCOS, 51 non-PCOS women) for 24 weeks. Outcome measures were AMH, follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol, dehydroepiandrosterone sulfate, and androstenedione. In PCOS women, we observed a significant treatment effect on FSH (mean treatment effect 0.94, 95% confidence interval [CI] 0.087 to 1.799, p = 0.031) and LH/FSH ratio (mean treatment effect −0.335, 95% CI −0.621 to 0.050, p = 0.022), whereas no significant effect was observed in non-PCOS women. In PCOS women, VD treatment for 24 weeks had a significant effect on FSH and LH/FSH ratio but no effect on AMH levels.

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