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The effect of brexpiprazole in adult outpatients with early-episode schizophrenia: an exploratory study.

ABSTRACT: The aim of this study was to evaluate flexibly dosed brexpiprazole for early-episode schizophrenia through the assessment of efficacy, social functioning, and tolerability. This was an exploratory, 16-week, open-label, flexible-dose (1, 2, 3, or 4?mg/day; target dose 3?mg/day) study in outpatients with early-episode schizophrenia (18-35 years old, ?5 years' duration of illness). Efficacy was assessed by the Positive and Negative Syndrome Scale score (PANSS) and social functioning was assessed by changes from baseline in PANSS modified prosocial subscale, personal and social performance (PSP), and specific levels of functioning (SLOF) scales. Safety and tolerability were also evaluated. Overall, 25/49 patients completed the study. Symptoms of schizophrenia improved over the entire treatment period, as evidenced by reductions in PANSS total score from baseline (least squares mean change at week 16: -10.2). Improvements in social functioning were shown by least squares mean changes from baseline at week 16 in the PANSS prosocial subscale (-2.0), PSP (6.6), and SLOF (13.1). Brexpiprazole was generally well tolerated; the most common adverse events were insomnia (7/49 patients), somnolence (4/49), sedation, weight increase, and nausea (each 3/49). Brexpiprazole may represent a novel and effective treatment strategy for patients with early-episode schizophrenia and may be effective for improving social function.

SUBMITTER: Malla A

PROVIDER: S-EPMC5049948 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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The effect of brexpiprazole in adult outpatients with early-episode schizophrenia: an exploratory study.

Malla Ashok A Ota Ai A Nagamizu Kazuhiro K Perry Pamela P Weiller Emmanuelle E Baker Ross A RA

International clinical psychopharmacology 20161101 6

The aim of this study was to evaluate flexibly dosed brexpiprazole for early-episode schizophrenia through the assessment of efficacy, social functioning, and tolerability. This was an exploratory, 16-week, open-label, flexible-dose (1, 2, 3, or 4 mg/day; target dose 3 mg/day) study in outpatients with early-episode schizophrenia (18-35 years old, ≤5 years' duration of illness). Efficacy was assessed by the Positive and Negative Syndrome Scale score (PANSS) and social functioning was assessed by ...[more]

PMID: 27571460

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Project description:BACKGROUND:Long-term treatment with antipsychotic medications in early episode schizophrenia spectrum disorders is common, but both short and long-term effects on the illness are unclear. There have been numerous suggestions that people with early episodes of schizophrenia appear to respond differently than those with multiple prior episodes. The number of episodes may moderate response to drug treatment. OBJECTIVES:To assess the effects of antipsychotic medication treatment on people with early episode schizophrenia spectrum disorders. SEARCH STRATEGY:We searched the Cochrane Schizophrenia Group register (July 2007) as well as references of included studies. We contacted authors of studies for further data. SELECTION CRITERIA:Studies with a majority of first and second episode schizophrenia spectrum disorders comparing initial antipsychotic medication treatment with placebo, milieu, or psychosocial treatment. DATA COLLECTION AND ANALYSIS:Working independently, we critically appraised records from 681studies, of which five studies met inclusion criteria. John Rathbone from the Schizophrenia Group supported us with the data extraction. We calculated risk ratios (RR) and their 95% confidence intervals (CI) where possible. For continuous data, we calculated mean difference (MD). We calculated numbers needed to treat/harm (NNT/NNH) where appropriate. MAIN RESULTS:Five studies with a combined N = 998 met inclusion criteria. Four studies (N = 724) provided leaving the study early data and results suggested that individuals treated with a typical antipsychotic medication are less likely to leave the study early than those treated with placebo (Chlorpromazine: 3 RCTs N = 353, RR 0.4 CI 0.3 to 0.5, NNT 3.2, Fluphenaxine: 1 RCT N = 240, RR 0.5 CI 0.3 to 0.8, NNT 5; Thioridazine: 1 RCT N = 236, RR 0.44 CI 0.3 to 0.7, NNT 4.3, Trifulperazine: 1 RCT N = 94, RR 0.96 CI 0.3 to 3.6). Two studies (Cole 1964; May 1976) contributed data to assessment of side effects and present a general pattern of more frequent side effects among individuals treated with typical antipsychotic medications compared to placebo. Rappaport 1978 suggested a higher rehospitalisation rate for those receiving chlorpromazine compared to placebo (N = 80, RR 2.29 CI 1.3 to 4.0, NNH 2.9). However, a higher attrition in the placebo group is likely to have introduced a survivor bias into this comparison, as this difference becomes non-significant in a sensitivity analysis on intent-to-treat participants (N = 127, RR 1.69 CI 0.9 to 3.0). One study (May 1976) contributes data to a comparison of trifluoperazine to psychotherapy on long-term health in favour of the trifluoperazine group (N = 92, MD 5.8 CI 1.6 to 0.0); however, data from this study are also likely to contain biases due to selection and attrition. One study (Mosher 1995) contributes data to a comparison of typical antipsychotic medication to psychosocial treatment on six-week outcome measures of global psychopathology (N = 89, MD 0.01 CI -0.6 to 0.6) and global improvement (N = 89, MD -0.03 CI -0.5 to 0.4), indicating no between-group differences. On the whole, there is very little useable data in the few studies meeting inclusion criteria. AUTHORS' CONCLUSIONS:With only a few studies meeting inclusion criteria, and with limited useable data in these studies, it is not possible to arrive at definitive conclusions. The preliminary pattern of evidence suggests that people with early episode schizophrenia treated with typical antipsychotic medications are less likely to leave the study early, but more likely to experience medication-related side effects. Data are too sparse to assess the effects of antipsychotic medication on outcomes in early episode schizophrenia.

Project description:ObjectivesTo evaluate the usability of a neuropsychological screening instrument and two observation scales of everyday behaviour to describe cognitive and functional capacity of patients with multiepisode schizophrenia and considerable care needs, who frequently refuse to participate in cognitive testing or performance-based functional measurement.SettingOne psychiatric unit specialised in severe mental illness at the Sahlgrenska University Hospital, Gothenburg, Sweden.ParticipantsPatients were included consecutively from date of admission to the unit.Inclusion criteriaage 18-65 years, International Classification of Diseases 10 diagnoses F20.0-F20.9 (schizophrenia) or F25.0-F25.9 (schizoaffective disorder) since at least 5 years.Exclusion criteriaacute serious psychotic episodes or physical illness, alcohol or drug abuse during the year before the study, diagnosed cerebral disorder at admission to the unit, and insufficient ability to speak Swedish. 64 patients filled the criteria and 19 accepted participation: 14 males, 5 females, median age 56 years.Outcome measuresBarrow Neurological Institute Screen for Higher Cerebral Functions (BNIS) scores, measured by a psychologist; Frontal Systems Behaviour Scale (FrSBe) Family Version and Functional Independence Measure (FIM) V.4.0 scores, measured by nursing staff. Non-parametric statistics were consistently applied to process the data.ResultsFailure analysis showed differences regarding gender and subdiagnoses between participants and non-participants. All participants had BNIS scores indicating cognitive dysfunction. FrSBe group medians showed apathy and executive problems, indicating possible frontal lobe disturbance. FIM showed dependency on others for linguistic and social communication, everyday problem solving, and remembering persons and daily routines. Correlations between FrSBe and FIM (p?0.01) suggested executive dysfunction being crucial to explain difficulties in performing activities of daily functioning.ConclusionsIndications of considerable cognitive and functional difficulties found among the participants suggestedthat the instruments are clinically applicable for tentative assessment of cognitive and functional ability among patients with multiepisode schizophrenia and considerable care needs.

Project description:ObjectiveThis study used a decision-analytic framework to assess the cost-effectiveness of brexpiprazole vs comparator branded therapies for reducing relapses and hospitalizations among adults with schizophrenia from a US payer perspective.MethodsAn economic model was developed to assess patients with stable schizophrenia initiating treatment with brexpiprazole (1-4 mg), cariprazine (1-6 mg), or lurasidone (40-80 mg) over a 1-year period. After 6 months, patients remained on treatment or discontinued due to relapse, adverse events, or other reasons. Patients who discontinued due to relapse or adverse events were assumed to have switched to other therapy, and those who discontinued due to other reasons were assumed to have received no therapy. Primary outcomes were incremental cost per relapse avoided and hospitalization avoided, and the secondary outcome was cost per quality-adjusted life-year (QALY) gained. Sensitivity and scenario analyses were also conducted.ResultsBrexpiprazole was associated with the highest per-patient clinical effectiveness (avoided relapses 0.637, avoided hospitalizations 0.719, QALYs 0.707) among comparators, followed by cariprazine (avoided relapses 0.590, avoided hospitalizations 0.683, QALYs 0.683) and lurasidone (avoided relapses 0.400, avoided hospitalizations 0.536, QALYs 0.623). Annual per-patient health-care costs were lowest for brexpiprazole ($20,510), followed by cariprazine ($22,282) and lurasidone ($25,510). Brexpiprazole was the least costly and most effective treatment strategy for all outcomes. Results were sensitive to relapse rates and daily cost of brexpiprazole. Limitations include data principally obtained from drug-specific randomized withdrawal studies and lack of direct-comparison trials.ConclusionThis analysis evaluated brexpiprazole treatment for the reduction of schizophrenia relapses and hospitalizations over a 1-year period compared to other recently available branded antipsychotics, and excluded generic antipsychotic treatments. Brexpiprazole treatment may lead to clinical benefits and medical cost savings, and provides a cost-effective treatment option for patients relatively to other branded second-generation antipsychotics.

Dataset Information

The effect of brexpiprazole in adult outpatients with early-episode schizophrenia: an exploratory study.

Publications

The effect of brexpiprazole in adult outpatients with early-episode schizophrenia: an exploratory study.

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