scholarly journals Evaluation of Efficacy, Safety, and Cognitive Profile of Amisulpride Per Se and Its Comparison with Olanzapine in Newly Diagnosed Schizophrenic Patients in an 8-Week, Double-Blind, Single-Centre, Prospective Clinical Trial

2012 ◽  
Vol 2012 ◽  
pp. 1-5 ◽  
Author(s):  
Ganesh R. Pawar ◽  
P. Phadnis ◽  
A. Paliwal

Background. Impaired cognitive functions in schizophrenia are the major deciding factors in response to treatment. Conventional antipsychotics have minimal impact on cognitive dysfunctions and are associated with adverse effects. Atypical antipsychotics have shown promise in treatment of cognitive and negative symptoms of schizophrenia. Efforts are underway to find out the best drug amongst atypical antipsychotics. Objective. To compare efficacy, safety, and cognitive profile of amisulpride and olanzapine in the treatment of acute psychotic exacerbations of schizophrenia. Method. A prospective, randomized, double-blind, single-center, 8-week clinical trial we used. Subjects and Treatments. Seventy four patients were treated for two months with either amisulpride (400–800 mg/d) or olanzapine (10–20 mg/d). Statistics. Mann Whitney U test we used for independent samples with taken as significant. Results. Brief psychiatric rating scale (BPRS) was used as a primary measure of efficacy. Other measures of efficacy and safety were also evaluated. Both amisulpride and olanzapine groups showed equivalent improvement in psychotic symptoms on BPRS scale. Less than five percent of patients suffered adverse effects only to withdraw from the study. Olanzapine group showed statistically significant () weight gain compared with amisulpride group. Amisulpride group showed significant improvement () in various cognitive parameters as compared to olanzapine group.

1997 ◽  
Vol 171 (6) ◽  
pp. 569-573 ◽  
Author(s):  
Roni Shiloh ◽  
Zvi Zemishlany ◽  
Dov Aizenberg ◽  
Marguerite Radwan ◽  
Bruria Schwartz ◽  
...  

BackgroundWe hypothesised that a combined regimen of clozapine, a relatively weak D2-dopaminergic antagonist, and sulpiride, a selective D2 blocker, would demonstrate a greater antipsychotic efficacy by enhancing the D2 blockade of clozapine.MethodTwenty-eight people with schizophrenia, previously unresponsive to typical antipsychotics and only partially responsive to current treatment with clozapine, received, double-blind, 600 mg/day sulpiride or placebo, in addition to an ongoing clozapine treatment. The clinical status was evaluated before, during, and at the end of 10 weeks of sulpiride addition using the Brief Psychiatric Rating Scale (BPRS), Scale for the Assessment of Positive Symptoms (SAPS), Scale for the Assessment of Negative Symptoms, and Hamilton Rating Scale for Depression.ResultsThe clozapine–sulpiride group exhibited substantially greater and significant improvements in positive and negative psychotic symptoms. About half of them, characterised by a younger age and lower baseline SAPS scores, had a mean reduction of 42.4 and 50.4% in their BPRS and SAPS scores, respectively.ConclusionsA subgroup of patients with chronic schizophrenia may substantially benefit from sulpiride addition to clozapine.


2020 ◽  
Vol 34 (5) ◽  
pp. 506-513 ◽  
Author(s):  
Ehsan Moazen-Zadeh ◽  
Samaneh Bayanati ◽  
Kimia Ziafat ◽  
Farzin Rezaei ◽  
Bita Mesgarpour ◽  
...  

Introduction and objectives: Vortioxetine, a novel antidepressant, may be an interesting candidate for adjunctive therapy of schizophrenia. Our primary objective was to investigate the effect of vortioxetine on negative symptoms, with the assessment of positive, general psychopathology and total symptoms as our secondary goal. Methods: This was an eight-week randomised, double-blind, placebo-controlled, parallel-group clinical trial, in which 78 inpatients with chronic schizophrenia were stabilised with risperidone (4–6 mg/day) for two months before being assigned to adjunctive vortioxetine (10 mg b.i.d.) or placebo. The patients were assessed using the Positive and Negative Syndrome Scale (PANSS), Extrapyramidal Symptom Rating Scale and Hamilton Depression Rating Scale during the study course. All participants had a PANSS negative symptoms subscale score of ⩾16 at baseline. Sixty-eight patients completed the trial. Results: Vortioxetine improved the negative symptoms score as the primary outcome and total PANSS score as a secondary outcome significantly better than placebo from baseline to end point at week 8, accompanied by significant time × treatment interactions and effect sizes (negative symptoms: mean difference (95% confidence interval (CI)) = −1.82 (−2.73 to −0.92); total scores: mean difference (95% CI) = −2.09 (−3.16 to −1.01). No significant difference was detected for changes in positive symptoms score or PANSS general psychopathology score as the other secondary outcomes from baseline to end point between the two treatment arms. The incidence of adverse events was comparable between groups. Conclusions: This is the first study to provide evidence for the therapeutic effect of vortioxetine on negative symptoms as an adjunctive to treatment with antipsychotics in patients with schizophrenia.


2014 ◽  
Vol 2014 ◽  
pp. 1-6 ◽  
Author(s):  
Ahmad Ghanizadeh ◽  
Motahhar OmraniSigaroodi ◽  
Ali Javadpour ◽  
Mohammad Hossein Dabbaghmanesh ◽  
Sara Shafiee

Objectives. Many patients with bipolar disorder suffer from metabolic disorder. Lovastatin is effective for treating major depression. This double-blind randomized placebo controlled clinical trial investigates whether lovastatin is a useful adjuvant to lithium for treating mania.Methods. Fifty-four patients with bipolar disorder-manic phase were randomly allocated into lovastatin or placebo group. The clinical symptoms were assessed at baseline, week 2, and week 4 using Young Mania Rating Scale. Adverse effects were checked.Results. Forty-six out of 54 patients completed this trial. The mania score in the lovastatin group decreased from 40.6 (11.1) at baseline to 12.9 (8.7) and 4.1 (5.4) at weeks 2 and 4, respectively. The score in the placebo group decreased from 41.0 (11.2) at baseline to 12.8 (8.07) and 5.8 (4.6) at weeks 2 and 4, respectively. However, there was no significant difference between groups at week 2 and week 4. The adverse effects rates were comparable between the two groups. No serious adverse effect was found. Tremor and nausea were the most common adverse effects.Conclusions. Lovastatin neither exacerbated nor decreased the symptoms of mania in patients with bipolar disorder. Current results support that the combination of lovastatin with lithium is tolerated well in bipolar disorder. The trial was registered with the Iranian Clinical Trials Registry (IRCT201302203930N18).


2021 ◽  
pp. 1-12
Author(s):  
Alexandra Martini Oliveira ◽  
Marcia Radanovic ◽  
Patricia Cotting Homem de Mello ◽  
Patricia Cardoso Buchain ◽  
Adriana Dias Barbosa Vizzotto ◽  
...  

Background: Neuropsychiatric symptoms (NPS) such as aggression, apathy, agitation, and wandering may occur in up to 90%of dementia cases. International guidelines have suggested that non-pharmacological interventions are as effective as pharmacological treatments, however without the side effects and risks of medications. An occupational therapy method, called Tailored Activity Program (TAP), was developed with the objective to treat NPS in the elderly with dementia and has been shown to be effective. Objective: Evaluate the efficacy of the TAP method (outpatient version) in the treatment of NPS in individuals with dementia and in the burden reduction of their caregivers. Methods: This is a randomized, double-blind, controlled clinical trial for the treatment of NPS in dementia. Outcome measures consisted of assessing the NPS of individuals with dementia, through the Neuropsychiatric Inventory-Clinician rating scale (NPI-C), and assessing the burden on their caregivers, using the Zarit Scale. All the participants were evaluated pre-and post-intervention. Results: 54 individuals with dementia and caregivers were allocated to the experimental (n = 28) and control (n = 26) groups. There was improvement of the following NPS in the experimental group: delusions, agitation, aggressiveness, depression, anxiety, euphoria, apathy, disinhibition, irritability, motor disturbance, and aberrant vocalization. No improvement was observed in hallucinations, sleep disturbances, and appetite disorders. The TAP method for outpatient settings was also clinically effective in reducing burden between caregivers of the experimental group. Conclusion: The use of personalized prescribed activities, coupled with the caregiver training, may be a clinically effective approach to reduce NPS and caregiver burden of individuals with dementia.


2021 ◽  
pp. 193864002098092
Author(s):  
Gholamreza Raissi ◽  
Amin Arbabi ◽  
Maryam Rafiei ◽  
Bijan Forogh ◽  
Arash Babaei-Ghazani ◽  
...  

Design Chronic plantar fasciitis (PF) is a common cause of chronic heel pain, with different conventional treatment options. In this randomized clinical trial, the effect of ultrasound-guided injection of dextrose versus corticosteroid in chronic PF was evaluated and compared. Methods A total of 44 patients suffering from chronic PF who visited the physical medicine and rehabilitation clinic were enrolled in the study. Two table-randomized groups were formed. They received an ultrasonography-guided, single injection of either 40 mg methylprednisolone or 20% dextrose. Numeric Rating Scale (NRS), Foot and Ankle Ability Measure questionnaire with 2 subscales, Activities of Daily Living (FAAM-A) and Sports (FAAM-S), along with ultrasonographic parameters were evaluated before and at 2 and 12 weeks after the injection. Results. A total of 40 participants completed the study. Both interventions significantly improved pain and function at 2 and 12 weeks postinjection. After 2 weeks, compared with the dextrose prolotherapy, the corticosteroid group had significantly lower daytime and morning NRS scores (2.55 vs 4.1, P = .012, and 2.75 vs 4.65, P = .004), higher FAAM-S (66.84 vs 54.19; P = .047), and lower plantar fascia thickness at insertion and 1 cm distal to the insertion zone (3.89 vs 4.29 mm, P = .004, and 3.13 vs 3.48 mm, P = .002), whereas FAAM-A was similar in both groups ( P = .219). After 12 weeks, all study variables were statistically similar between corticosteroid and dextrose prolotherapy groups. No injection-related side effects were recorded in either group. Conclusion Both methods are effective. Compared with dextrose prolotherapy, our results show that corticosteroid injection may have superior therapeutic effects early after injection, accompanied by a similar outcome at 12 weeks postinjection. Levels of Evidence: Level II


Author(s):  
James A. Koziol ◽  
Adriana Lucero ◽  
Jack C. Sipe ◽  
John S. Romine ◽  
Ernest Beutler

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.


1973 ◽  
Vol 1 (3) ◽  
pp. 145-150 ◽  
Author(s):  
K Jepson ◽  
G Beaumont

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.


2020 ◽  
Vol 46 (Supplement_1) ◽  
pp. S218-S218
Author(s):  
David Kim ◽  
Ric Procyshyn ◽  
Lik Hang Lee ◽  
William Panenka ◽  
Olga Leonova ◽  
...  

Abstract Background There is considerable evidence supporting the association between extrapyramidal symptoms (EPS) and psychotic symptoms in patients with schizophrenia (SCZ). However, it is not well understood whether such an association exists in individuals without SCZ and how the association differs from those with SCZ. Our aim was to examine the associations of EPS with psychotic symptoms and compare them between SCZ and non-SCZ individuals. Methods We used data from a 10-year community-based study of homeless or precariously housed persons from Vancouver, Canada. Diagnosis of SCZ was made according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR). Severity of psychotic symptoms was rated using the Positive and Negative Syndrome Scale (PANSS). Severity of parkinsonism, dyskinesia, and dystonia was rated using the Extrapyramidal Symptom Rating Scale (ESRS), and akathisia using the Barnes Akathisia Rating Scale (BARS). Presence of EPS was defined as having at least moderate severity on the ESRS (i.e., ≥4 out of 8) or BARS (i.e., ≥3 out of 5) Clinical Global Impression-Severity (CGI-S) scale. Absence of EPS was defined as scoring ≤2 on the ESRS or ≤1 on the BARS CGI-S scale. Two-way analysis of covariance was performed using SCZ and EPS as independent variables and PANSS five factors (i.e., positive symptoms, negative symptoms, disorganization, excitement, and depression) as dependent variables, controlling for age, antipsychotic users, and cocaine- or methamphetamine-dependent individuals. Multiple linear regression analysis was performed for both SCZ and non-SCZ groups, controlling for the same confounding variables, to examine 1) associations of the severity of EPS subtypes with PANSS factors and 2) whether the presence of multiple EPS subtypes would be associated with increased SCZ symptoms relative to the presence of a single subtype. Results A total of 223 participants were included in this study (mean age: 44.1 ± 12.0 years; 76.1% male). Eighty-four participants met the diagnosis of SCZ, of whom 39 met our criteria for having EPS and 32 for not having EPS. The remaining 139 participants were not diagnosed with SCZ, of whom 50 had EPS and 72 did not. None of the participants had clinically significant dystonia. Overall, significant main effects of EPS were found for total symptoms (F1,182 = 24.4, p < 0.001), negative symptoms (F1,182 = 16.3, p < 0.001), disorganization (F1,181 = 16.6, p < 0.001), and excitement (F1,182 = 15.8, p < 0.001), but not positive symptoms or depression. The presence of EPS was associated with greater total symptoms and disorganization in both SCZ and non-SCZ groups. Significant interaction effects between SCZ and EPS were found for negative symptoms (F1,182 = 6.0, p = 0.015) and excitement (F1,182 = 3.9, p = 0.050), where the presence of EPS was associated with greater negative symptoms and excitement in SCZ participants, but not in non-SCZ participants. Consistent in both SCZ and non-SCZ groups, there were significant positive associations of the severity of 1) parkinsonism with negative symptoms, 2) dyskinesia with disorganization and total symptoms, and 3) akathisia with excitement. The presence of multiple EPS subtypes, relative to a single subtype, was not associated with significant increases in any SCZ symptoms, except a significant increase in excitement in non-SCZ participants. Discussion The presence of EPS is clearly associated with greater symptoms of SCZ, even in individuals without SCZ. People with SCZ may experience greater negative symptoms and excitement as a result of EPS than those without SCZ. Subtypes of EPS are distinctively associated with factors of SCZ symptoms. Future studies should elucidate the mechanisms underlying these associations.


BMJ Open ◽  
2019 ◽  
Vol 9 (5) ◽  
pp. e028486 ◽  
Author(s):  
Jessica Mandrioli ◽  
Valeria Crippa ◽  
Cristina Cereda ◽  
Valentina Bonetto ◽  
Elisabetta Zucchi ◽  
...  

IntroductionDisruptions of proteasome and autophagy systems are central events in amyotrophic lateral sclerosis (ALS) and support the urgent need to find therapeutic compounds targeting these processes. The heat shock protein B8 (HSPB8) recognises and promotes the autophagy-mediated removal of misfolded mutant SOD1 and TDP-43 fragments from ALS motor neurons (MNs), as well as aggregating species of dipeptides produced in C9ORF72-related diseases. In ALS-SOD1 mice and in human ALS autopsy specimens, HSPB8 is highly expressed in spinal cord MNs that survive at the end stage of disease. Moreover, the HSPB8–BAG3–HSP70 complex maintains granulostasis, which avoids conversion of dynamic stress granules (SGs) into aggregation-prone assemblies. We will perform a randomised clinical trial (RCT) with colchicine, which enhances the expression of HSPB8 and of several autophagy players, blocking TDP-43 accumulation and exerting crucial activities for MNs function.Methods and analysisColchicine in amyotrophic lateral sclerosis (Co-ALS) is a double-blind, placebo-controlled, multicentre, phase II RCT. ALS patients will be enrolled in three groups (placebo, colchicine 0.01 mg/day and colchicine 0.005 mg/day) of 18 subjects treated with riluzole; treatment will last 30 weeks, and follow-up will last 24 weeks. The primary aim is to assess whether colchicine decreases disease progression as measured by ALS Functional Rating Scale - Revised (ALSFRS-R) at baseline and at treatment end. Secondary aims include assessment of (1) safety and tolerability of Colchicine in patiets with ALS; (2) changes in cellular activity (autophagy, protein aggregation, and SG and exosome secretion) and in biomarkers of disease progression (neurofilaments); (3) survival and respiratory function and (4) quality of life. Preclinical studies with a full assessment of autophagy and neuroinflammation biomarkers in fibroblasts, peripheral blood mononuclear cells and lymphoblasts will be conducted in parallel with clinic assessment to optimise time and resources.Ethics and disseminationThe study protocol was approved by the Ethics Committee of Area Vasta Emilia Nord and by Agenzia Italiana del Farmaco (EUDRACT N.2017-004459-21) based on the Declaration of Helsinki. This research protocol was written without patient involvement. Patients’ association will be involved in disseminating the study design and results. Results will be presented during scientific symposia or published in scientific journals.Trial registration numberEUDRACT 2017-004459-21;NCT03693781; Pre-results.


1998 ◽  
Vol 13 (2) ◽  
pp. 104-106 ◽  
Author(s):  
M Moldavsky ◽  
D Stein ◽  
R Benatov ◽  
P Sirota ◽  
A Elizur ◽  
...  

SummaryThree adolescent and two adult patients suffering from chronic excited psychoses (either schizophrenia or schizoaffective disorder) resistant to traditional neuroleptics and clozapine were treated with combined clozapine-lithium. Improvement was assessed with the Positive and Negative Symptoms Scale, the Brief Psychiatric Rating Scale and the Clinical Global Impressions, administered before and during combined clozapine-lithium treatment. All patients demonstrated a significant improvement with this combination. There was no occurrence of agranulocytosis, neuroleptic malignant syndrome or other clinically significant adverse effects.


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