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Kane J.M.,The Zucker Hillside Hospital
The Journal of clinical psychiatry | Year: 2013

Too many patients with schizophrenia do not achieve the ultimate goal of treatment-recovery. The first step to recovery is achieving response to treatment for the acute psychotic episode. Clinicians should routinely use rating scales to measure treatment response. The next phase is remission of symptoms, which is one of the criteria for recovery. Relapses, however, can disrupt remission and hinder recovery by causing rehospitalization, treatment resistance, and loss of gains in function. Medication adherence plays a major role in preventing relapses so that patients can maintain remission and work toward recovery. Clinicians should educate patients about adherence and consider treatment options that will improve adherence. Recovery is attained when patients experience symptom remission, vocational role fulfillment, independent living, and social relationships for at least 2 years. The proportion of patients who reach recovery can be increased when clinicians focus on treatment adherence, consistent symptom measurement, and appropriate treatment plans tailored to each patient. © Copyright 2013 Physicians Postgraduate Press, Inc.

Kane J.M.,The Zucker Hillside Hospital | Yang R.,Cephalon Inc. | Youakim J.M.,Cephalon Inc.
Schizophrenia Research | Year: 2012

Objective: A prior 4-week, proof-of-concept study suggested that adjunctive therapy with armodafinil 200. mg/day decreases negative symptoms in patients with clinically stable schizophrenia. This study investigated the efficacy and tolerability of adjunctive armodafinil for treatment of negative symptoms in adults with schizophrenia receiving antipsychotic medications. Methods: This parallel-group, 24-week study enrolled adults with schizophrenia who were receiving oral olanzapine, risperidone, or paliperidone for ≥. 6. weeks, and had a Positive and Negative Syndrome Scale (PANSS) negative symptom subscale score of ≥. 15. Patients received one of 3 doses of once-daily armodafinil (150. mg, 200. mg, or 250. mg) or placebo. The primary efficacy measure was the change from baseline to final visit in the PANSS negative symptom subscale score. Secondary measures included the PANSS total score, Clinical Global Impression of Severity, Personal and Social Performance Scale, and CNSVitalSigns cognitive battery. Results: Of 285 randomized patients, 213 received armodafinil and 72 received placebo. The mean (SD) changes in PANSS negative symptom subscale score were - 1.9 (3.8) for armodafinil 150. mg (n = 70), -2.3 (3.6) for armodafinil 200. mg (n = 69), -2.0 (3.3) for armodafinil 250. mg (n = 71), and - 2.2 (4.1) for placebo (n = 70) (p. ≥. 0.70 for each armodafinil group versus placebo). Secondary measures were generally not different between groups. Armodafinil was generally well tolerated, without worsening positive symptoms. Conclusions: This study found no benefit of adjunctive armodafinil versus placebo for negative symptoms in patients with schizophrenia receiving treatment with olanzapine, risperidone, or paliperidone. Armodafinil was generally well tolerated in these patients. © 2011 Elsevier B.V.

Loebel A.,Sunovion Pharmaceuticals | Cucchiaro J.,Sunovion Pharmaceuticals | Xu J.,Sunovion Pharmaceuticals | Sarma K.,Sunovion Pharmaceuticals | And 2 more authors.
Schizophrenia Research | Year: 2013

Objective: To evaluate the relapse prevention efficacy of lurasidone compared with quetiapine XR (QXR) in adults patients with schizophrenia. Method: This double-blind study evaluated the relapse prevention efficacy of 12. months of flexible-dose treatment with lurasidone (40-160. mg/day) compared with QXR (200-800. mg/day), in outpatients with an acute exacerbation of chronic schizophrenia who had recently completed a 6-week placebo-controlled trial of treatment with either lurasidone or QXR. The primary endpoint, time-to-relapse, was analyzed using a Cox proportional hazards model in this noninferiority trial. Results: The Kaplan-Meier estimate of the probability of relapse over 12. months was 23.7% for subjects receiving lurasidone vs. 33.6% for QXR. The hazard ratio [95% CI] for probability of relapse was 0.728 [0.410, 1.295] (log-rank p = 0.280). Since the upper limit of the hazard ratio (1.295) was smaller than the prespecified noninferiority margin (1.93), noninferiority of lurasidone compared with QXR was demonstrated in this study. The probability of hospitalization at 12. months was lower for the lurasidone group compared with the QXR group (9.8% vs. 23.1%; log-rank p = 0.049). A significantly higher proportion of lurasidone subjects achieved remission at study endpoint compared with the QXR group (61.9% vs. 46.3%; p = 0.043). Discontinuation rates due to AEs were similar for lurasidone and QXR (7% vs. 5%). Treatment with lurasidone was not associated with clinically significant changes in weight or metabolic parameters. Conclusions: Twelve months of treatment with lurasidone met noninferiority criteria, and was associated with higher rates of remission, and reduced risk of hospitalization compared with QXR. No clinically significant effects on weight or metabolic parameters were observed during maintenance treatment with lurasidone. © 2013 Elsevier B.V.

Pediatric bipolar disorder (PBD) is associated with poor outcomes, including suicidal ideation (SI) and suicide attempt (SA). However, frequencies and risk factors of SI/SA and targeted intervention trials for SI/SA in PBD have not been reviewed systematically. We conducted a systematic PubMed review, searching for articles reporting on prevalences/incidences, correlates and intervention studies targeting SI/SA in PBD. Weighted means were calculated, followed by an exploratory meta-regression of SI and SA correlates. Fourteen studies (n = 1595), in which 52.1% of patients were male and the mean age was 14.4 years, reported data on SI/SA prevalence (N = 13, n = 1508) and/or correlates (N = 10, n = 1348) in PBD. Weighted mean prevalences were: past SI = 57.4%, past SA = 21.3%, current SI = 50.4%, and current SA = 25.5%; incidences (mean 42 months of follow-up) were: SI = 14.6% and SA = 14.7%. Regarding significant correlates, SI (N = 3) was associated with a higher percentage of Caucasian race, narrow (as opposed to broad) PBD phenotype, younger age, and higher quality of life than SA. Significant correlates of SA (N = 10) included female sex, older age, earlier illness onset, more severe/episodic PBD, mixed episodes, comorbid disorders, past self-injurious behavior/SI/SA, physical/sexual abuse, parental depression, family history of suicidality, and poor family functioning. Race, socioeconomic status, living situation, and life events were not clearly associated with SA. In a meta-regression analysis, bipolar I disorder and comorbid attention-deficit hyperactivity disorder were significantly associated with SA. Only one open label study targeting the reduction of SI/SA in PBD was identified. SI and SA are very common but under-investigated in PBD. Exploration of predictors and protective factors is imperative for the establishment of effective preventive and intervention strategies, which are urgently needed. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Kane J.M.,The Zucker Hillside Hospital
The Journal of clinical psychiatry | Year: 2013

Although effective treatments for negative symptoms are currently limited, clinicians still need to assess and monitor them because of their impact on patient functioning. Further, documenting patients' negative symptoms provides a complete clinical record that the clinician can use to make systematic and careful treatment decisions. Several tools for assessing negative symptoms in schizophrenia are available, including the Clinical Global Impression scale (CGI), the Brief Psychiatric Rating Scale (BPRS), the Positive and Negative Syndrome Scale (PANSS), the Scale for the Assessment of Negative Symptoms (SANS), the 16-item Negative Symptoms Assessment (NSA-16), and the Schedule for Deficit Syndrome (SDS). Additionally, newer instruments are in development-the Clinical Assessment Interview for Negative Symptoms (CAINS) and the Brief Negative Symptoms Scale (BNSS)-and are yielding promising results. This overview outlines these assessment tools so that clinicians can measure negative symptom severity and track treatment response for their patients with schizophrenia. © Copyright 2013 Physicians Postgraduate Press, Inc.

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