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

Németh, György; Laszlovszky, István; Czobor, Pál; Szalai, Erzsébet; Szatmári, B.; Harsányi, J.; Born, Christoph; Debelle, M.; Durgam, Suresh; Bitter, István; Marder, Stephen R.; Fleischhacker, W. Wolfgang

doi:10.1016/s0140-6736(17)30060-0

Cited by 255 publications

(270 citation statements)

References 30 publications

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“…In accordance with the comparator treatment assessed in the Németh et al clinical trial [8], the Markov state transition model compares cariprazine with risperidone.…”

Section: Comparatormentioning

confidence: 99%

“…The weekly transition probabilities (i.e., the numerical likelihoods of patients moving from one PANSS state to another) for both the cariprazine and the risperidone arm were acquired from the first 4 weeks of the Németh et al clinical trial [8]. For the latter periods, transition probabilities were acquired from the cases where the time period between any two PANSS assessments was between 11 and 13 weeks (77-93 days).…”

Section: Transition Probabilitiesmentioning

confidence: 99%

“…The analysis of adverse events (AEs) in the Németh et al clinical trial [8] were done based on the patients reported AEs at the visits. In the trial, the number of reported cases of all examined AEs was low on both arms (Table 3).…”

Section: Adverse Eventsmentioning

confidence: 99%

“…The study was a two-arm superiority trial. Details of study design, inclusions and exclusions criteria were described in detail by Németh et al [8]. The study had a sufficiently long treatment period (26 weeks) to judge and score patients' symptoms severity after a cross-titration period of 2 weeks and randomized 231 patients into the risperidone and 230 patients into the cariprazine treatment arms.…”

mentioning

confidence: 99%

“…The purpose of the analysis reported in this paper was to estimate the gain in quality-adjusted life years (QALYs) that could be achieved over 54 weeks by the use of cariprazine in the treatment of schizophrenia for patients with PNS compared with the widely used second-generation antipsychotic drug, risperidone, based on the PANSS data from the Németh et al clinical trial [8]. The approach has been taken to use trial results to identify how patients move from initial PANSS states to other states over time, dependent on whether they are being treated with risperidone or cariprazine and to use a previously developed algorithm for converting PANSS scores to utility estimates to allow the calculation of QALYs.…”

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confidence: 99%

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Quality-adjusted life year difference in patients with predominant negative symptoms of schizophrenia treated with cariprazine and risperidone

Németh¹,

Molnár²,

Akehurst

et al. 2017

J. Comp. Eff. Res.

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Aim:Our study aimed at estimating differences in quality-adjusted life year (QALY) gain for patients with predominant negative symptoms of schizophrenia treated with cariprazine compared with risperidone. Materials & methods:A Markov model was built, based on the Mohr-Lenert approach and data derived from clinical trials, to estimate potential QALY gains of patients. Results: Patients had higher probability of reaching better health states treated with cariprazine compared with risperidone. In the model, this resulted in an estimated QALY gain of 0.029 per patient, after 1 year of treatment. Conclusion: Cariprazine, which showed clinically meaningful improvement in the symptoms, and personal and social performance, can also provide significant QALY gain in the treatment of patients with predominant negative symptoms of schizophrenia compared with risperidone.

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“…In accordance with the comparator treatment assessed in the Németh et al clinical trial [8], the Markov state transition model compares cariprazine with risperidone.…”

Section: Comparatormentioning

confidence: 99%

Section: Transition Probabilitiesmentioning

confidence: 99%

Section: Adverse Eventsmentioning

confidence: 99%

mentioning

confidence: 99%

mentioning

confidence: 99%

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Quality-adjusted life year difference in patients with predominant negative symptoms of schizophrenia treated with cariprazine and risperidone

Németh¹,

Molnár²,

Akehurst

et al. 2017

J. Comp. Eff. Res.

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Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Symptoms in Schizophrenia

et al. 2020

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IMPORTANCE Negative symptoms represent a substantial burden in schizophrenia. Although preliminary studies have suggested that transcranial direct current stimulation (tDCS) is effective for some clusters of symptoms, the clinical benefits for negative symptoms are unclear.OBJECTIVE To determine the efficacy and safety of tDCS vs sham as an add-on treatment for patients with schizophrenia and predominant negative symptoms. DESIGN, SETTING, AND PARTICIPANTS The double-blind Schizophrenia Treatment With Electric Transcranial Stimulation (STARTS) randomized clinical trial was conducted from September 2014 to March 2018 in 2 outpatient clinics in the state of São Paulo, Brazil. Patients with schizophrenia with stable negative and positive symptoms and a minimum score of 20 points in the negative symptoms subscale of the Positive and Negative Syndrome Scale (PANSS) were included. INTERVENTIONS Ten sessions of tDCS performed twice a day for 5 days or a sham procedure. The anode and the cathode were positioned over the left prefrontal cortex and the left temporoparietal junction, respectively. MAIN OUTCOMES AND MEASURESChange in the PANSS negative symptoms subscale score at week 6 was the primary outcome. Patients were followed-up for an additional 6 weeks. RESULTSOf the 100 included patients, 20 (20.0%) were female, and the mean (SD) age was 35.3 (9.3) years. A total of 95 patients (95.0%) finished the trial. In the intention-to-treat analysis, patients receiving active tDCS showed a significantly greater improvement in PANSS score compared with those receiving the sham procedure (difference, 2.65; 95% CI, 1.51-3.79; number needed to treat, 3.18; 95% CI, 2.12-6.99; P < .001). Response rates for negative symptoms (20% improvement or greater) were also higher in the active group (20 of 50 [40%]) vs the sham group (2 of 50 [4%]) (P < .001). These effects persisted at follow-up. Transcranial direct current stimulation was well tolerated, and adverse effects did not differ between groups, except for burning sensation over the scalp in the active group (43.8%) vs the sham group (14.3%) (P = .003).CONCLUSIONS AND RELEVANCE Transcranial direct current stimulation was effective and safe in ameliorating negative symptoms in patients with schizophrenia.

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Schizophrenia and Related Psychoses

2021

The Maudsley Prescribing Guidelines in Psychiatry

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Despite disagreements about nomenclature, patients who develop schizophrenic or schizophrenialike symptoms in later life are often seen in clinical practice. Questions about the etiology of late-life psychotic disorders and about their similarities or differences from early-onset disorders remain unanswered. Neuroimaging techniques have been used to study patients with late onset of psychosis, and in substantial subgroups of patients (from 25% to 100% in various studies) compared with agematched control subjects, structural and functional abnormalities have been found. We review the literature on imaging in late-life schizophrenia and related psychotic disorders, and we present data from our own investigations of patients with these disorders. We discuss the potential usefulness of imaging evaluations in patients with late-onset disorders, and we offer suggestions for future investigations.

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

Cited by 255 publications

References 30 publications

Quality-adjusted life year difference in patients with predominant negative symptoms of schizophrenia treated with cariprazine and risperidone

Quality-adjusted life year difference in patients with predominant negative symptoms of schizophrenia treated with cariprazine and risperidone

Efficacy and Safety of Transcranial Direct Current Stimulation for Treating Negative Symptoms in Schizophrenia

Schizophrenia and Related Psychoses

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