Monotherapy treatment with cariprazine for the treatment of predominant negative symptoms of patients with schizophrenia: A double-blind, active comparator-controlled trial

2016 ◽  
Vol 33 (S1) ◽  
pp. s256-s257 ◽  
Author(s):  
G. Németh ◽  
M. Debelle ◽  
I. Laszlovszky ◽  
E. Szalai ◽  
B. Szatmári ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Partial Agonist ◽  
Social Performance ◽  
Controlled Trial ◽  
Dose Range ◽  
Treatment Change ◽  
Double Blind ◽  
Preferential Binding ◽  
Competing Interest ◽  
Risperidone Group

ObjectiveTo examine the effect of cariprazine, a dopamine D3/D2 receptor partial agonist with preferential binding to D3 receptors, on predominant negative symptoms of schizophrenia.MethodsSubjects with schizophrenia and PANSS factor score for negative symptoms (PANSS-FSNS) ≥ 24 and no pseudospecific factors (e.g. extrapyramidal symptoms, depression) were randomized to cariprazine 4.5 mg/d (dose range: 3-6 mg/d) or risperidone 4 mg/d (dose range: 3-6 mg/d) for 6 months.ResultsFour hundred and sixty-one patients were randomized 1:1 to double-blind risperidone (n = 231) or cariprazine (n = 230) treatment. Change from Baseline (CfB) at week 26 in the primary parameter, PANSS-FSNS, was larger in the cariprazine group than in the risperidone group (LSMD = −1.47; 95% CI: [−2.39, −0.53]; P = 0.002) significant from week 14 onwards. CfB at week 26 in the functional parameter, Personal and Social Performance (PSP) total score, showed similarly greater improvement with cariprazine than risperidone (LSMD = 4.63; 95% CI: [2.71, 6.56]; P < 0.001) significant from week 10 onward. Statistically significant differences in favor of cariprazine at week 26 were shown in the PSP areas of self-care, socially useful activities and personal and social relationships. Most patients tolerated the study treatment well, as reflected by low discontinuation rates due to adverse events (AEs). Adverse event profiles of cariprazine and risperidone were similar. The most common AEs during study treatment were insomnia (10.0%), and headache (10.4%), both in the risperidone group.Conclusion26-week cariprazine treatment, given as antipsychotic monotherapy, was significantly more effective on negative symptoms and on functioning than risperidone in patients with predominant negative symptoms of schizophrenia.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Diagnosis of Predominant Negative Symptoms: Post-hoc Analyses of a Phase 3 Clinical Trial with Cariprazine Monotherapy and Risperidone

2017 ◽  
Vol 41 (S1) ◽  
pp. S270-S270
Author(s):  
I. Laszlovszky ◽  
Á. Barabássy ◽  
E. Szalai ◽  
B. Szatmári ◽  
J. Harsányi ◽  
...  
Keyword(s):  
Patient Population ◽  
Negative Symptoms ◽  
Social Performance ◽  
Dose Range ◽  
Patient Characteristics ◽  
Phase 3 ◽  
Double Blind ◽  
Parallel Group ◽  
Baseline Values ◽  
Post Hoc

ObjectiveTo present, post hoc analyses from a controlled, prospective study of predominant negative symptoms (PNS) of schizophrenia on baseline patient characteristics, severity of symptoms and their variability among participating countries.MethodsData were analyzed from a phase 3, randomized, double-blind, active-controlled, parallel-group study in adult PNS patients with schizophrenia (EudraCT Number 2012-005485-36). Subjects with a PANSS factor score for negative symptoms (PANSS-FSNS) ≥ 24 and no pseudo-specific factors (e.g. high positive symptoms, extrapyramidal symptoms, depression) were randomized to cariprazine 4.5 mg/d (dose range: 3–6 mg/d) or risperidone 4 mg/d (dose range: 3–6 mg/d) for 26 weeks. Baseline values of PANSS-FSNS, individual PANSS items, personal and social performance (PSP), and clinical global impression of severity (CGI-S) were analyzed based on the data gained from 11 European participating countries.ResultsAverage PANSS-FSNS of patients was 27.6 ± 2.48, reflecting severe negative symptoms. Patients were moderately ill (CGI-S 4.2 ± 0.75), with marked difficulties (PSP 48.4 ± 10.78) predominantly in social functioning. The investigated patient population was fairly homogeneous as shown by small variability in all three scores. Moreover, baseline values in the 11 countries presented low variability while number of enrolled patients per country showed high variance (n = 7–118). Narrative description of symptoms and individual PANSS items rated as most severe and prominent were in high correlation.ConclusionPost hoc evaluation of this predominant negative symptom study showed that, this patient population can be identified reliably by psychiatrist. Additional training on the judgment of personal and social relationships can increase the diagnostic accuracy.Disclosure of interestEmployee of Gedeon Richter Plc.

scholarly journals Adjunctive Garcinia mangostana Linn. (Mangosteen) Pericarp for Schizophrenia: A 24-Week Double-blind, Randomized, Placebo Controlled Efficacy Trial: Péricarpe d’appoint Garcinia mangostana Linn (mangoustan) pour la schizophrénie : un essai d’efficacité de 24 semaines, à double insu, randomisé et contrôlé par placebo

2020 ◽  
pp. 070674372098243
Author(s):  
Alyna Turner ◽  
Andrea Baker ◽  
Olivia M. Dean ◽  
Adam J. Walker ◽  
Seetal Dodd ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Schizoaffective Disorder ◽  
Negative Symptoms ◽  
Controlled Trial ◽  
Safety Data ◽  
Rate Of Change ◽  
Adjunctive Treatment ◽  
Garcinia Mangostana ◽  
Double Blind

Objectives: Garcinia mangostana Linn. (“mangosteen”) pericarp contains bioactive compounds that may target biological pathways implicated in schizophrenia. We conducted a double-blind randomized placebo-controlled trial evaluating the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. Methods: People diagnosed with schizophrenia or schizoaffective disorder ( Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks postdiscontinuation). Data were collected from July 2016 to February 2019. Results: Baseline assessments were conducted on 148 people (mangosteen = 74, placebo = 74); data analyses were conducted on 136 (92%) participants with postbaseline data. The treatment group had significantly higher symptom severity compared to placebo, and both groups significantly improved on all symptom, functioning, and quality of life measures over time. No between-group differences were found for the rate of change between baseline and 24 or 28 weeks. Conclusion: Despite promising preclinical and clinical work, our results do not support mangosteen pericarp extract as an adjunctive treatment for schizophrenia or schizoaffective disorder.

Aripiprazole once-monthly efficacy in patients with schizophrenia. Review

2016 ◽  
Vol 33 (S1) ◽  
pp. S582-S582
Author(s):  
M.F. Molina López ◽  
M.C. Cancino Botello ◽  
A. Peña Serrano ◽  
M.D.L.A. Canseco Navarro
Keyword(s):  
Quality Of Life ◽  
Negative Symptoms ◽  
Partial Agonist ◽  
Emotional Interaction ◽  
Medication Delivery ◽  
Pubmed Database ◽  
Competing Interest ◽  
Long Acting

Introductionlong acting injectable formulations of antipsychotics are a valuable option for patients with schizophrenia, offering continuous medication delivery and stable dosage levels. Aripiprazole once-monthly is the first dopamine partial agonist available in long acting formulation approved in Europe for Schizophrenia with excellent results so far.Aimsto conduct a current review of articles related to the use and efficacy of Aripiprazole once monthly in patients with Schizophrenia.Methodssystematic review of the literature in English using the following keywords: “aripiprazole once-monthly”, “aripiprazole long acting formulation”, “schizophrenia”. PubMed database.ResultsAripiprazole once-monthly (AOM) formulation efficacy has been proven in many studies. The importance of maintaining an oral overlap during 14 days is highlighted in all studies that have been reviewed in order to reach therapeutic level; therefore, it can be used in patients with acute decompensations. Recent studies comparing AOM versus Paliperidone Palmitate once monthly (PP) have shown that patients with AOM had greater clinical improvement and, even though both drugs were well tolerated, when Quality of Life Style Scale was analyzed an important improvement in empathy, sense of purpose, emotional interaction and curiosity in the AOM group was observed.Conclusionslong acting injectable antipsychotics increase long-term adherence treatment and reduce risk of relapse. Because of its unique mechanism of action, Aripiprazole once-monthly improves positive and negative symptoms, giving the patient an opportunity to have a better quality of life.Disclosure of interestThe authors have not supplied their declaration of competing interest.

Cariprazine versus risperidone monotherapy for treatment of predominant negative symptoms in patients with schizophrenia: a randomised, double-blind, controlled trial

The Lancet ◽  
2017 ◽  
Vol 389 (10074) ◽  
pp. 1103-1113 ◽  
Author(s):  
György Németh ◽  
István Laszlovszky ◽  
Pál Czobor ◽  
Erzsébet Szalai ◽  
Balázs Szatmári ◽  
...  
Keyword(s):  
Negative Symptoms ◽  
Controlled Trial ◽  
Double Blind

Comparison of ED95 of Butorphanol and Sufentanil for Gastrointestinal Endoscopy Sedation: a Randomized Controlled Trial

2020 ◽  
Author(s):  
Xiaona Zhu ◽  
Limei Chen ◽  
Shuang Zheng ◽  
Linmin Pan
Keyword(s):  
Recovery Time ◽  
Partial Agonist ◽  
Controlled Trial ◽  
Randomized Study ◽  
Sequential Method ◽  
Double Blind ◽  
Gi Endoscopy ◽  
Severity Scores ◽  
Clinical Trail ◽  
Group B

Abstract Background: Butorphanol, a synthetic opioid partial agonist analgesic, has been widely used to control perioperative pain. However, the ideal dose and availability of butorphanol for gastrointestinal (GI) endoscopy are not well known. The aim of this study was to evaluated the 95% effective dose (ED95) of butorphanol and sufentanil in GI endoscopy and compared their clinical efficacy, especially regarding the recovery time. Methods: The study was divided into two parts. For the first part, voluntary patients who needed GI endoscopy anesthesia were recruited to measure the ED95 of butorphanol and sufentanil needed to achieve successful sedation before GI endoscopy using the sequential method (the Dixon up-and-down method). The second part was a double-blind, randomized study. Two hundred cases of painless GI endoscopy patients were randomly divided into two groups (n= 100), including group B (butorphanol at the ED95 dose) and group S (sufentanil at the ED95 dose). Propofol was infused intravenously as the sedative in both groups. The recovery time, visual analogue scale (VAS) score, hand grip strength, fatigue severity scores, incidence of nausea and vomiting, and incidence of dizziness were recorded.Results: The ED95 of butorphanol for painless GI endoscopy was 9.07 μg/kg (95% confidence interval: 7.81-19.66 μg/kg). The ED95 of sufentanil was 0.1 μg/kg (95% CI, 0.079-0.422 μg/kg). Both butorphanol and sufentanil provided a good analgesic effect for GI endoscopy. However, the recovery time for butorphanol was significantly shorter than that for sufentanil (P < 0.05, group B vs. group S:21.26 ± 7.70 vs. 24.03 ± 7.80 min).Conclusions: Butorphanol at 9.07μg/kg was more effective than sufentanil for GI endoscopy sedation and notably reduced the recovery time.Trial registration: Chinese Clinical Trail Registry (Registration number # ChiCTR1900022780; Date of Registration on April 25rd, 2019) http://www.chictr.org.cn/showproj.aspx?proj= 37972.

Escitalopram versus risperidone for the treatment of behavioral and psychotic symptoms associated with Alzheimer's disease: a randomized double-blind pilot study

2011 ◽  
Vol 23 (9) ◽  
pp. 1515-1519 ◽  
Author(s):  
Yoram Barak ◽  
Igor Plopski ◽  
Shelly Tadger ◽  
Diana Paleacu
Keyword(s):  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Adverse Events ◽  
Controlled Trial ◽  
Treated Group ◽  
Psychotic Symptoms ◽  
Completion Rates ◽  
Double Blind ◽  
Once Daily ◽  
Risperidone Group

ABSTRACTBackground: Antipsychotics are frequently used to treat psychosis, aggression and agitation in patients with Alzheimer's disease (AD), but safety warnings abound. Escitalopram was investigated since citalopram has demonstrated some effectiveness in AD. We compared escitalopram and risperidone for psychotic symptoms and agitation associated with AD.Methods: Inpatients with AD, who had been hospitalized because of behavioral symptoms, were recruited to a six-week randomized, double-blind, controlled trial. Participants (n = 40) were randomized to once daily risperidone 1 mg or escitalopram 10 mg.Results: The NPI total score improved in both groups. Onset was earlier in the risperidone-treated group, but improvement did not significantly differ between groups by study end. Completion rates differed for escitalopram (75%) and risperidone (55%), mainly due to adverse events. There were no adverse events in the escitalopram group, while in the risperidone group two patients suffered severe extrapyramidal symptoms and four patients suffered acute physical illness necessitating transfer to general hospital.Conclusion: Escitalopram and risperidone did not differ in efficacy in reducing psychotic symptoms and agitation in patients with AD. Completion rates were higher for escitalopram-treated patients. Replication in larger trials with ambulatory patients is needed.

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