A comparative study between lithium and extended-release carbamazepine in acute mania: a double-blind clinical trial

2020 ◽  
Vol 09 ◽  
Author(s):  
Saeed Shoja Shafti ◽  
Hamid Kaviani
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Lithium Carbonate ◽  
Acute Mania ◽  
Prolonged Release ◽  
Double Blind Study ◽  
Double Blind ◽  
Global Improvement ◽  
The Third ◽  
The Mean

Background: Recently, numerous large clinical trials have been performed to evaluate the effectiveness and tolerability of extended-release formulations of carbamazepine in bipolar disorder. Objective: In the current study we compared lithium with a prolonged-release form of carbamazepine (Tegretol CR), to evaluate its efficiency and safety in a group of patients with diagnosis of acute mania. Method: Fifty patients with diagnosis of acute mania, entered into a three-week, double-blind study, for random assignment to lithium carbonate or tegretol CR. The main outcome measure in the present evaluation was the Manic State Rating Scale (MSRS), which was scored at baseline and weekly intervals up to the third week. Moreover, insight and overall illness severity and improvement were assessed using the Schedule for Assessment of Insight (SAI), the Clinical Global Impressions-Global Improvement scale (CGI-I), and the Clinical Global Impressions Severity Scale (CGI-S), respectively. While statistical significance had been defined as p value ≤0.05, treatment efficacy had been analyzed by independent samples t-test and repeated measures analysis of variance (ANOVA). Results: Despite the fact that the mean total score of MSRS improved significantly by both lithium carbonate and tegretol CR at the end of the third week, between-group analysis showed significant advantage of lithium, regarding both frequency and intensity of symptoms, at the end of study. The mean total score of SAI, as well, showed significant improvement by both of them. Nevertheless, while the CGI-I demonstrated significant improvement by participants taking lithium and tegretol CR, the CGI-S showed significant progress only by lithium. Besides, the Cohen’s effect size analysis showed large improvement of MSRS by lithium and medium improvement by tegretol CR. Post-hoc power analysis showed an intermediate power of 0.42 on behalf of the current evaluation. Conclusion: While both lithium carbonate and tegretol CR were valuable for improvement of manic symptoms, management with lithium appears to be more helpful.

Effectiveness of Extended-release Formulation of Quetiapine as Monotherapy for the Treatment of Acute Bipolar Mania (Trial D144CC00004)

2009 ◽  
Vol 24 (S1) ◽  
pp. 1-1 ◽  
Author(s):  
C. Datto ◽  
A. Nordenhem ◽  
M. Minkwitz ◽  
B. Dettore ◽  
L. Acevedo ◽  
...  
Keyword(s):  
Extended Release ◽  
Rating Scale ◽  
Analysis Of Covariance ◽  
Secondary Outcome ◽  
Double Blind Study ◽  
Double Blind ◽  
Once Daily ◽  
Bipolar I Disorder ◽  
Manic Symptoms ◽  
Quetiapine Xr

Objectives:To evaluate the effectiveness of extended release quetiapine fumarate (quetiapine XR) as once-daily monotherapy for manic symptoms in bipolar I disorder.Methods:In this 3-week, randomized, parallel-group, double-blind study, adults with bipolar I disorder (most recent episode manic or mixed; with or without rapid cycling) were randomized to once-daily treatment with either quetiapine XR (n=149; Day 1, 300 mg; Day 2, 600 mg; Day 3 through Week 3, 400-800 mg flexibly dosed) or placebo (n=159). Primary outcome measure was change from baseline to Week 3 in Young Mania Rating Scale (YMRS) total score. Secondary outcome measures included YMRS response and remission and change in Clinical Global Impression-Bipolar (CGI-BP)-Severity of Illness and -Change scales. Change from baseline was compared between groups with analysis of covariance, using the last observation carried forward approach for missing data.Results:Once-daily quetiapine XR was associated with significant, sustained improvement in manic symptoms compared with placebo, beginning on Day 4 (P< 0.001) and continuing through Week 3 (mean change: -14.34 versus -10.52; P< 0.001). At Week 3, quetiapine XR-treated patients showed significantly greater response (P< 0.01) and remission (P< 0.01) rates and improvement in CGI-BP-associated scores than placebo-treated patients. Adverse events were mild to moderate in intensity, the most common being sedation, dry mouth, and somnolence for quetiapine XR.Conclusions:Once-daily quetiapine XR monotherapy (400-800 mg) was efficacious (from Day 4 through Week 3) and generally well tolerated in the treatment of manic episodes associated with bipolar I disorder.Supported by funding from AstraZeneca Pharmaceuticals LP.

Evaluation of the Efficacy of ST2 and NT-proBNP in the Diagnosis and Prediction of Short- Term Prognosis in Heart Failure with Reduced Ejection Fraction

2017 ◽  
Vol 9 (04) ◽  
Author(s):  
Shivananda B Nayak ◽  
Dharindra Sawh ◽  
Brandon Scott ◽  
Vestra Sears ◽  
Kareshma Seebalack ◽  
...  
Keyword(s):  
Heart Failure ◽  
Ejection Fraction ◽  
Cardiac Biomarkers ◽  
Double Blind Study ◽  
Short Term ◽  
Double Blind ◽  
Reduced Ejection Fraction ◽  
The Mean ◽  
Design And Methods ◽  
The Relationship

Purpose: i) To determine the relationship between the cardiac biomarkers ST2 and NT-proBNP with ejection fraction (EF) in heart failure (HF) patients. ii) Assess whether a superiority existed between the aforementioned cardiac markers in diagnosing the HF with reduced EF. iii) Determine the efficacy of both biomarkers in predicting a 30-day cardiovascular event and rehospitalization in patients with HF with reduced EF iv) To assess the influence of age, gender, BMI, anaemia and renal failure on the ST2 and NT-proBNP levels. Design and Methods: A prospective double-blind study was conducted to obtain data from a sample of 64 cardiology patients. A blood sample was collected to test for ST2 and NT-proBNP. An echocardiogram (to obtain EF value), electrocardiogram and questionnaire were also obtained. Results: Of the 64 patients enrolled, 59.4% of the population had an EF less than 40%. At the end of the 30- day period, 7 patients were warded, 37 were not warded, one died and 17 were non respondent. Both biomarkers were efficacious at diagnosing HF with a reduced EF. However, neither of them were efficacious in predicting 30-day rehospitalization. The mean NT-proBNP values being: not rehospitalized (2114.7486) and 30 day rehospitalization (1008.42860) and the mean ST2 values being: not rehospitalized (336.1975), and 30-day rehospitalization. (281.9657). Conclusion: Neither ST2 or NT-proBNP was efficacious in predicting the short- term prognosis in HF with reduced EF. Both however were successful at confirming the diagnosis of HF in HF patients with reduced EF.

Propofol Anaesthesia in Electroconvulsive Therapy

1994 ◽  
Vol 165 (4) ◽  
pp. 506-509 ◽  
Author(s):  
Christopher F. Fear ◽  
Carl S. Littlejohns ◽  
Eryl Rouse ◽  
Paul McQuail
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Electroconvulsive Therapy ◽  
Rating Scale ◽  
Induction Agent ◽  
Double Blind Study ◽  
Major Depressive ◽  
Seizure Duration ◽  
Double Blind ◽  
Induction Agents

BackgroundThe induction agent propofol is known to reduce electroconvulsive therapy (ECT) seizure duration. It is assumed that outcome from depression is adversely affected by this agent. This study compares propofol and methohexitone as induction agents for ECT.MethodIn a prospective, randomised, double-blind study 20 subjects with major depressive disorder (DSM-III-R criteria) received propofol or methohexitone anaesthesia. The Hamilton Depression Rating Scale and Beck Depression Inventory were used to assess depression before therapy, at every third treatment, and at the end of therapy. Seizure duration was measured using the cuff technique.ResultsMean seizure durations (P < 0.01) and mean total seizure duration (P < 0.01) were shorter in the propofol group. There was no difference in outcome.ConclusionsUse of propofol may not adversely affect outcome from depression and it is not necessarily contraindicated as an induction agent for ECT. Our results should be interpreted cautiously, and larger studies are needed.

The Effectiveness of Group Acceptance and Commitment Therapy and Cognitive Therapy on Alexithymia and Marital Boredom, Case study: Women Affected by Marital Infidelity in Mashhad, Iran

2022 ◽  
Author(s):  
Maryam Sadeghi ◽  
Naeimeh Moheb ◽  
Marziyeh Alivandi Vafa
Keyword(s):  
Cognitive Therapy ◽  
Analysis Of Covariance ◽  
Control Group ◽  
Double Blind Study ◽  
University Counseling Center ◽  
Double Blind ◽  
University Counseling ◽  
Acceptance And Commitment ◽  
Marital Infidelity ◽  
The Mean

Introduction: The aim of current paper was to compare the effectiveness of acceptance and commitment group therapy (ACT) and group cognitive therapy (GCT) on Alexithymia and marital boredom (MB) among women affected by marital infidelity in Mashhad. Method: This clinical trial was a double- blind study with a pretest-posttest design in which two intervention groups and one control group were investigated. The study performed on women who realized their spouse infidelity and referred to Azad University Counseling Center in Mashhad in 2018. The sample consisted of 30 women who were selected by purposive sampling and were randomly assigned to two intervention groups and a control group (n=10 per group). The intervention groups were put under ACT training (twelve 90-minute sessions) and GCT training (twelve 90-minute sessions), but the control group did not receive any intervention. Data was obtained by the Toronto Alexithymia Scale-20 and Pines Marital Boredom Scale and was analyzed by multivariate analysis of covariance with SPSS (version 22) software. Results: The results showed a significant reduction in the mean score of MB in the ACT group, also there was a significant reduction in the mean score of Alexithymia in the GCT group (P <0.05). So comparing both therapies, ACT was more influential on reducing marital boredom whereas GCT was more effective on reducing alexithymia. Conclusion: Although both intervention methods were effective on Alexithymia and Marital Boredom in women affected by marital infidelity, it was demonstrated that ACT and GCT have more effect on Marital Boredom and Alexithymia, respectively.

scholarly journals Effects of ondansetron on respiratory pattern and sensation of experimentally induced dyspnea

2002 ◽  
Vol 120 (5) ◽  
pp. 141-145 ◽  
Author(s):  
José Antônio Baddini Martinez ◽  
Fábio Senra Rocha ◽  
Elizabet Sobrani ◽  
Fabíola Paula Lovreto Galhardo ◽  
João Terra Filho
Keyword(s):  
Respiratory Diseases ◽  
Insular Cortex ◽  
Respiratory Pattern ◽  
Double Blind Study ◽  
Double Blind ◽  
Respiratory Discomfort ◽  
The Mean ◽  
Respiratory Conditions ◽  
Voluntary Apnea ◽  
Study Setting

CONTEXT: Dyspnea remains a therapeutic challenge, especially in chronic respiratory conditions. Recent studies have shown that the induction of unpleasant dyspnea sensations activates areas in the insular cortex. OBJECTIVE: This study was designed to investigate the potential effects of ondansetron, a potent anti-serotonin agent, on induced dyspnea sensation. TYPE OF STUDY: A randomized double blind study. SETTING: Pulmonary Function Laboratory of Hospital das Clínicas de Ribeirão Preto. PARTICIPANTS: Ten healthy male volunteers (mean age ± standard error = 23.1 ± 0.41 years) without respiratory diseases and showing normal spirometric tests. INTERVENTIONS: Uncomfortable breathing was induced in the volunteers on two different days, via the use of inspiratory resistors (loads of 0, 7, 14 and 21 cm H2O/l/sec) and breathholding, two hours after taking 8 mg of ondansetron (Ond) or placebo (Plac). MAIN MEASUREMENTS: Respiratory discomfort during breathing under loading was evaluated on a 100-mm visual analog scale. The maximum length of time of voluntary apnea was measured in seconds. RESULTS: The mean maximum voluntary apnea time did not differ between the ondansetron and placebo days (Plac = 96 ± 6.6 sec vs. Ond = 100 ± 7.9 sec). Ondansetron did not influence the dyspnea sensation induced by different inspiratory loads (0 cm H2O/l/sec: Ond = 1.4 mm ± 0.44 vs. Plac = 2.1 ± 0.85 mm; 7 cm H2O/l/sec: Ond = 16.6 ± 2.74 mm vs. Plac = 13.7 ± 2.06 mm; 14 cm H2O/l/sec; Ond = 30.5 ± 4.50 mm vs. Plac = 27.1 ± 3.44 mm; 21 cm H2O/l/sec: Ond = 50.3 ± 6.72 mm vs. Plac = 49.4 ± 6.72 mm). Ondansetron led to significant decreases in tidal volume under basal conditions and when breathing under the highest inspiratory loading (0 cm H2O/l/sec: Ond = 0.83 ± 0.26 l vs. Plac = 1.0 ± 0.28 l; 21 cm H2O/l/sec: Ond = 0.86 ± 0.23 l vs. Plac = 1.1 ± 0.22 l) CONCLUSION: The present results suggest that 5-HT3 receptors do not play an important role in the mediation of dyspnea sensations.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Nalbuphine ER Tablets for Uremic Pruritus

2017 ◽  
Vol 46 (6) ◽  
pp. 450-458 ◽  
Author(s):  
Vandana S. Mathur ◽  
Jayant Kumar ◽  
Paul W. Crawford ◽  
Howard Hait ◽  
Thomas Sciascia ◽  
...  
Keyword(s):  
Rating Scale ◽  
Numerical Rating Scale ◽  
Controlled Trial ◽  
Hemodialysis Patients ◽  
Opioid Antagonist ◽  
Opioid Agonist ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Uremic Pruritus ◽  
The Mean

Background: Pruritus is a distressing hallmark of the uremic condition, affecting approximately 60% of hemodialysis patients. Abnormal endogenous opioid ligand activity at μ and κ-opioid receptors has been postulated as a mechanism in uremic pruritus. Nalbuphine is a μ-opioid antagonist and κ-opioid agonist. Methods: In this multicenter, randomized, double-blind, placebo-controlled trial, 373 hemodialysis patients with moderate or severe uremic pruritus were randomized in a 1: 1:1 ratio to nalbuphine extended-release tablets 120 mg (NAL 120), 60 mg (NAL 60), or placebo and treated for 8 weeks. Three hundred seventy-one were analyzed for efficacy. The primary endpoint was the change from baseline to treatment weeks 7 and 8 in itching intensity on a Numerical Rating Scale (NRS, 0 [no itching]; 10 [worst possible itching]) using an intent-to-treat approach. The aim was to evaluate the safety and antipruritic efficacy of NAL. Results: The mean duration of itching was 3.2 years. From a baseline NRS of 6.9 (1.5), the mean NRS declined by 3.5 (2.4) and by 2.8 (2.2) in NAL 120 mg and the placebo groups, respectively (p = 0.017). There was no evidence of tolerance. A trend for less sleep disruption due to itching (p = 0.062, NAL 120 vs. placebo) was also observed. There were no significant differences between NAL 60 vs. placebo. Serious adverse events occurred in 6.7, 12.7, and 15.4% in the NAL 120, NAL 60, and placebo groups respectively. Conclusions: In this largest-to-date randomized controlled trial in uremic pruritus, NAL 120 durably and significantly reduced the itching intensity among hemodialysis patients.

scholarly journals Efficacy of levomilnacipran extended-release in major depressive disorder: pooled analysis of 5 double-blind, placebo-controlled trials

CNS Spectrums ◽  
2014 ◽  
Vol 20 (2) ◽  
pp. 148-156 ◽  
Author(s):  
Stuart A. Montgomery ◽  
Carl P. Gommoll ◽  
Changzheng Chen ◽  
William M. Greenberg
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Extended Release ◽  
Rating Scale ◽  
Pooled Analysis ◽  
Major Depressive ◽  
Double Blind ◽  
Madrs Score ◽  
Wide Range ◽  
Remission Rates

Introduction/ObjectivePost hoc analyses were conducted to evaluate the efficacy of levomilnacipran extended-release (ER) in subgroups of patients with major depressive disorder (MDD).MethodsData were pooled from 5 completed Phase II/III studies. Patients were categorized by sex, age, MDD duration, recurrence of MDD, current episode duration, number of prior episodes, and baseline Montgomery–Åsberg Depression Rating Scale (MADRS) score. Efficacy was evaluated by MADRS least squares (LS) mean change from baseline, response (MADRS improvement ≥50%), and remission (MADRS ≤10).ResultsIn the pooled population, treatment with levomilnacipran ER versus placebo resulted in greater improvement in MADRS score (−15.8 versus −12.9; LS mean difference, −2.9; P < .001) and higher response rates (44.7% versus 34.5%; P < .001). Comparable treatment effects were found in most subgroups. Remission rates in the overall population were higher for levomilnacipran ER versus placebo (27.7% versus 21.5%; P < .05); notably high remission rates were seen in patients with baseline MADRS score < 30 (48.8% versus 28.9%; P < .001).DiscussionClinically meaningful improvements in depressive symptoms were found across subgroups, including statistically significant outcomes for both response and remission.ConclusionLevomilnacipran ER was efficacious across a wide range of MDD patients, including men and women, ages 18–78, with varying histories and symptom severity.

The Efficacy and Tolerability of Combined Antidepressant Treatment in Different Depressive Subgroups

1993 ◽  
Vol 162 (3) ◽  
pp. 363-368 ◽  
Author(s):  
Sinead O'brien ◽  
Patrick McKeon ◽  
Myra O'regan
Keyword(s):  
Treatment Group ◽  
Side Effects ◽  
Major Depression ◽  
Orthostatic Hypotension ◽  
Antidepressant Treatment ◽  
Combined Treatment ◽  
Endogenous Depression ◽  
Double Blind Study ◽  
Double Blind ◽  
Global Improvement

Eighty patients admitted to hospital with major depression were randomly allocated to six weeks of treatment with tranylcypromine, amitriptyline, or tranylcypromine and amitriptyline in combination, in a double-blind study. Scores on the HRSD improved significantly in all three groups, but there were no differences between the three groups. Patients on tranylcypromine and amitriptyline combined improved more according to their self-ratings after six weeks, and response was earlier as measured by a clinical global improvement scale. Those with endogenous depression improved more than those with neurotic depression, irrespective of treatment group. Combined treatment was less well tolerated than single treatments and gave rise to more side-effects, although there was no serious toxicity. Orthostatic hypotension was observed more frequently in patients on combined treatment. This group also experienced a significant increase in weight and prolongation of the P-R interval on ECG.

scholarly journals Time course of improvement with antipsychotic medication in treatment-resistant schizophrenia

2011 ◽  
Vol 199 (4) ◽  
pp. 275-280 ◽  
Author(s):  
Takefumi Suzuki ◽  
Gary Remington ◽  
Tamara Arenovich ◽  
Hiroyuki Uchida ◽  
Ofer Agid ◽  
...  
Keyword(s):  
Antipsychotic Medication ◽  
Time Course ◽  
Rating Scale ◽  
Antipsychotic Treatment ◽  
Treatment Resistant ◽  
Item Score ◽  
Double Blind ◽  
The Mean ◽  
Meta Regression ◽  
Item Scores

BackgroundImprovements are greatest in the earlier weeks of antipsychotic treatment of patients with non-resistant schizophrenia.AimsTo address the early time-line for improvement with antipsychotics in treatment-resistant schizophrenia.MethodRandomised double-blind trials of antipsychotic medication in adult patients with treatment-resistant schizophrenia were investigated (last search June 2010). A series of meta-regression analyses were carried out to examine the effect of time on the average item scores in the Positive and Negative Syndrome Scale (PANSS) or Brief Psychiatric Rating Scale (BPRS) at three or more distinct time points within the first 6 weeks of treatment.ResultsStudy duration varied from 4 weeks to 1 year and the definitions of treatment resistance as well as of treatment response were not necessarily consistent across 19 identified studies, resulting in highly variable rates of response (0–76%). The mean standardised baseline item score in the PANSS or BPRS was 3.4 (s.e. = 0.06) in the five studies included in the meta-regression analysis, with the average baseline Clinical Global Impression – Severity score being 5.2 (marked illness). For the pooled population treated with a range of antipsychotics (n = 1019), significant reductions in the mean item scores occurred during the first 4 weeks; improvements observed in later weeks were smaller and non-significant. In contrast, weekly improvement with clozapine was significant throughout (n = 356).ConclusionsOur findings provide preliminary evidence that the majority of improvement with antipsychotics may occur relatively early. More consistent improvements with clozapine may be associated with a gradual titration. To further elucidate response patterns, future studies are needed to provide data over regular intervals during earlier stages of treatment.

Comparison of a New Hypnotic (Finorgal) with Placebo in a Double-Blind Trial

1979 ◽  
Vol 7 (5) ◽  
pp. 387-390
Author(s):  
Gianni Baiotti
Keyword(s):  
Placebo Treatment ◽  
Blind Study ◽  
Double Blind Study ◽  
Double Blind Trial ◽  
Double Blind ◽  
Blind Trial ◽  
The Mean ◽  
Mean Time

The hypnotic effects of Finorgal (ethchlorvynol with diphenhydramine) were compared with those of placebo in a double-blind study with crossover of treatments in thirty-five hospital in-patients. During the four-week period of Finorgal treatment there was a significant reduction in the mean time elapsing between the administration of the hypnotic and the onset of sleep, and a significant increase in the duration of sleep, compared with the four weeks of placebo treatment. There was also a significant increase in the proportion of nights when the patients felt they had slept well, and in the incidence of morning ‘hangover’ and nocturnal confusion during the Finorgal treatment periods. Patients had to be actively woken in the morning significantly more often following Finorgal administration. In patients experiencing pain in the night there was a significant reduction in the occurrence of pain during the nights when Finorgal had been given.

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