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Biomedical subjects

Rajiv Tandon

Publications and source records attributed to Rajiv Tandon.

At least 19 recordsLinked to original sources
PubMed2006

A prospective, multicenter, randomized, parallel-group, open-label study of aripiprazole in the management of patients with schizophrenia or schizoaffective disorder in general psychiatric practice: Broad Effectiveness Trial With Aripiprazole (BETA).

OBJECTIVE: BETA was designed to evaluate the overall effectiveness of aripiprazole in patients with schizophrenia or schizoaffective disorder treated in a general psychiatry outpatient practice setting. METHODS: In this 8-week, multicenter, open-label study, 1,599 outpatients with schizophrenia or schizoaffective disorder were randomly assigned to receive either aripiprazole (n=1,295) or another antipsychotic medication (safety control [SC] group; n=304). Aripiprazole was initiated at 15 mg/d with the option to adjust between 10-30 mg/d. The SC medication was specifically selected for each patient by the clinician and dosed according to prescribing guidelines for that medication. The primary effectiveness measure was the Clinical Global Impression-Improvement (CGI-I) score of the aripiprazole group at study end point. Secondary measures included response rates and preference of medicine (POM) ratings by patients and caregivers. RESULTS: Sixty-five percent of aripiprazole patients completed the study. The mean aripiprazole dose at end point was 19.9 mg/d, with approximately 39% of patients starting and remaining at 15 mg/d. At end point, the mean CGI-I score of 2.77 demonstrated that aripiprazole was minimally to moderately effective; the mean CGI-I score for the SC group was 3.59 indicating minimally effective to no change. Fifty-three percent of aripiprazole patients responded to treatment (CGI-I score of 1 or 2; last-observation-carried-forward [LOCF]), and approximately 71% of patients and caregivers rated aripiprazole as better than the prestudy medication on the POM (LOCF). Incidence and severity of adverse events (AEs) were similar to those reported in double-blind, randomized, placebo-controlled aripiprazole clinical trials. The most frequent AE in the aripiprazole group was insomnia (24%). CONCLUSIONS: Aripiprazole was effective for the treatment of schizophrenia and schizoaffective disorder in a general psychiatry outpatient practice setting. Overall, aripiprazole was found to be effective by the treating clinician and well accepted by patients and caregivers over the 8-week treatment course.

Adult↗
PubMed2006

Strategies for maximizing clinical effectiveness in the treatment of schizophrenia.

The ultimate clinical objective in the treatment of schizophrenia is to enable affected individuals to lead maximally productive and personally meaningful lives. As with other chronic diseases that lack a definitive cure, the individual's service/recovery plan must include treatment interventions directed towards decreasing manifestations of the illness, rehabilitative services directed towards enhancing adaptive skills, and social support mobilization aimed at optimizing function and quality of life. In this review, we provide a conceptual framework for considering approaches for maximizing the effectiveness of the array of treatments and other services towards promoting recovery of persons with schizophrenia. We discuss pharmacological, psychological, and social strategies that decrease the burden of the disease of schizophrenia on affected individuals and their families while adding the least possible burden of treatment. In view of the multitude of treatments necessary to optimize outcomes for individuals with schizophrenia, effective coordination of these services is essential. In addition to providing best possible clinical assessment and pharmacological treatment, the psychiatrist must function as an effective leader of the treatment team. To do so, however, the psychiatrist must be knowledgeable about the range of available services, must have skills in clinical-administrative leadership, and must accept the responsibility of coordinating the planning and delivery of this multidimensional array of treatments and services. Finally, the effectiveness of providing optimal individualized treatment/rehabilitation is best gauged by measuring progress on multiple effectiveness domains. Approaches for efficient and reliable assessment are discussed.

Adaptation, Psychological↗
PubMed2005

Validation of the Investigator's Assessment Questionnaire, a new clinical tool for relative assessment of response to antipsychotics in patients with schizophrenia and schizoaffective disorder.

The success of long-term therapy in schizophrenia is contingent upon real-world effectiveness or improvements in several domains, including efficacy, safety and tolerability. This report describes the Investigator's Assessment Questionnaire (IAQ), a new 10-item instrument designed to assess relative effectiveness (efficacy, safety and tolerability) of antipsychotic medications in patients with schizophrenia or schizoaffective disorder. To measure content validity, 300 psychiatrists rated the importance of the IAQ items. Efficacy (i.e., positive and negative symptoms) was considered most important, but importance scores relative to the mean ranged only from 0.87 to 1.18, suggesting similar importance of the items. Cronbach's coefficient alpha values showed that the items were internally consistent. Factor analyses indicated that all IAQ items belong to a single domain. Data from the US Broad Effectiveness Trial of Aripiprazole were used for construct validation. Total IAQ score correlated significantly with time to treatment discontinuation (r=-0.50), Clinical Global Impressions-Improvement (CGI-I) score (r=0.76) and medication preference of patients (r=0.71) or caregivers (r=0.70). A one-unit decrease in IAQ score corresponded to an additional 1.35 days in the study and a decrease in CGI-I of 0.21 units. These results provide initial validation of the IAQ as a tool for evaluating antipsychotic response in patients with schizophrenia or schizoaffective disorder.

Adolescent↗
PubMed2005

Comparative efficacy of antipsychotics in the treatment of schizophrenia: a critical assessment.

Because of their broader spectrum of efficacy and lower risk of short- and long-term motor side-effects in comparison to first generation 'typical' antipsychotics (FGAs), second generation 'atypical' antipsychotics (SGAs) are rapidly becoming the standard of antipsychotic pharmacotherapy. It is unclear, however, as to how different SGAs compare in efficacy since the multitude of studies and integrative reviews seemingly provide discrepant information in this regard. To address this issue, we critically review three distinct approaches to analysis of data from randomized controlled clinical trials of the efficacy of SGAs in the treatment of schizophrenia and schizoaffective disorder: (i) comparing average improvement in symptomatology with different SGAs; (ii) comparing average improvement observed with different SGAs relative to haloperidol; and (iii) head-head trials comparing one SGA to another. We discuss the strengths and limitations of each approach with reference to the reports in which it was applied to assess comparative antipsychotic efficacy. We conclude that the most informative picture is obtained by using each of these strategies, looking at all available data, and then putting all the results together. Data thus far do not support claims of differential efficacy among SGAs with the singular exception of clozapine possibly still being the gold standard of antipsychotic efficacy in otherwise treatment-refractory schizophrenia. Dosing appears to be a critical variable in optimizing efficacy.

Antipsychotic Agents↗
PubMed2005

Defining and measuring clinical effectiveness in the treatment of schizophrenia.

OBJECTIVES: Expectations in treating schizophrenia are expanding beyond just controlling psychotic symptoms to include functional recovery. This report describes an approach to define and measure the clinical effectiveness of treatment in achieving these objectives. METHODS: A comprehensive literature review established that there is limited information about the meaning of the term "clinical effectiveness." To address this gap a consensus conference of schizophrenia researchers was held to consider the components of clinical effectiveness in real-world community practice and how these components can best be measured. RESULTS: The consensus of the researchers was that effective clinical treatment is characterized by four outcome domains: symptoms of disease, treatment burden, disease burden, and health and wellness. A clinical instrument to measure these four domains was constructed: Global Outcome Assessment of Life in Schizophrenia (GOALS). In using GOALS, clinicians rate each of the four domains on a scale of 1, very much improved, to 7, very much worse. Field-testing of this instrument is planned. CONCLUSIONS: Effective treatment interventions that combine optimal pharmacotherapy and targeted psychosocial treatments are raising expectations about the prospects of functional recovery among patients with schizophrenia. GOALS is proposed as one tool that can provide busy clinicians with a simple, objective measure of the effectiveness and outcomes of the clinical treatment they provide to patients with schizophrenia.

Affect↗
PubMed2005

Suicidal behavior in schizophrenia.

There is a high prevalence of suicidal behavior in individuals suffering from schizophrenia and recent investigations substantially elucidate this problem and provide useful insights about clinical risk factors, neurobiologic underpinnings and the impact of various treatments on reducing such behavior. The risk of suicide is greatest early in the course of schizophrenic illness but continues throughout life; risk factors for suicidal behavior include psychosis, depression and substance abuse. Effectively treating positive symptoms and depression, reducing substance abuse, avoiding akathisia, addressing demoralization and instilling hope are important elements in this treatment approach. The newer generation of atypical antipsychotics (particularly clozapine) and new psychologic approaches (particularly cognitive behavioral therapy) appear to be useful in reducing suicidality in schizophrenia. The significant advances in defining the neurobiologic basis of suicidality may enable the development of more effective treatments. The renewed emphasis on resilience and recovery as desired outcomes in schizophrenia and the accompanying sense of hope encourage optimism about effectively reducing suicidality in schizophrenia. Over the past 10 years, much has been learnt and hopefully this momentum will be translated into increasingly better outcomes.

Expert Testimony↗
PubMed2004

Quetiapine has a direct effect on the negative symptoms of schizophrenia.

Second-generation 'atypical' antipsychotics appear to be more effective than first-generation 'typical' antipsychotics in improving negative symptoms in schizophrenia; it is unclear, however, if this greater improvement represents a direct beneficial effect or is mediated indirectly by an antidepressant effect or the absence of extrapyramidal symptoms (EPS). To address this issue with reference to quetiapine ('Seroquel'), data were evaluated from four randomized, controlled clinical studies involving 1106 patients employing a path analysis model. The total effect of quetiapine on negative symptoms was measured using the Scale for Assessment of Negative Symptoms (SANS) total score. Indirect effects on negative symptoms via positive, depressive and EPS were assessed using appropriate instruments. Effect sizes were calculated by path analysis for the difference between treatment groups in change from baseline to endpoint in SANS total score. Analysis confirmed that quetiapine produced a greater overall improvement in negative symptoms than placebo (effect size 1.96); this was explained by a significant direct effect (p = 0.001; 44.2% of total improvement), and a secondary effect of improved positive symptoms (p < 0.001; 47.5% of total improvement), but was not a consequence of changes in depressive symptoms or EPS. Within the constraints of the path analysis methodology, these results indicate that quetiapine has a substantial direct effect on improving the negative symptoms of schizophrenia.

Antipsychotic Agents↗
PubMed2003

A paradigm for treatment of inpatient psychiatric disorders: from asylum to intensive care.

OBJECTIVE: No articles, chapters, or texts have been published in the last 5 years that detail a workable model of inpatient psychiatric treatment based on current, drastically changed realities. METHODS: We reviewed controlled studies on inpatient psychiatric care and pooled our clinical experience from two academic inpatient units and a Veterans Affairs inpatient unit. RESULTS: Major changes in systems of care, the population now being hospitalized, the emphasis on practicing evidence-based medicine, and decreased funding of inpatient psychiatric units have necessitated changes in the traditional paradigm of inpatient treatment. We describe the functions that an inpatient unit performs best and detail 1) objectives of treatment with an emphasis on the "focal problem", and 2) the specific treatment interventions, treatment team members, and outpatient links necessary to maximize post-hospital outcome for patient and family. CONCLUSION: Given current realities, the treatment paradigm that we recommend has evolved from an asylum-like long-stay model to one that is more like a medical-surgical intensive care unit with an emphasis on rapid diagnosis, psychopharmacological intervention, and laying the groundwork for effective outpatient management. In consequence, the expected clinical outcomes from an episode of inpatient psychiatric treatment are quite different from those of the recent past.

Journal Article↗
PubMed2003

Improvement without impairment: a review of clinical data for quetiapine in the treatment of schizophrenia.

Quetiapine fumarate is an atypical antipsychotic medication approved for the treatment of patients with schizophrenia and other psychotic disorders. Quetiapine is superior to placebo and at least equivalent to haloperidol for improving a broad range of symptoms encountered in patients with schizophrenia, including positive symptoms, negative symptoms, affective symptoms, and cognitive outcomes. Available data comparing quetiapine with other atypical antipsychotics, while limited, suggest it is as efficacious as other atypical agents and has a favorable tolerability profile; in particular, the incidence of motor adverse effects and prolactin elevation is comparable to that of placebo across its entire dose range. The favorable overall effectiveness of quetiapine suggests it is well suited for the long-term treatment of patients with psychotic disorders.

Dibenzothiazepines↗
PubMed2002

The making of a polio-free India.

Rotary one of the largest non-government international organization focused mainly towards the up-liftment of the downtrodden worldwide, got involved in the Polio Eradication Program way back in 1979 with a five-year pledge to immunize about six million Philippine children from the crippling disease of poliomyelitis. By 1982, Rotary committed itself to implement the most ambitious program ever, "to immunize all the world's children against polio by 2005" -Rotary's first birth centenary year. Encouraged by Rotary's commitment towards this objective, the World Health Organization (WHO) adopted a resolution of eradicating polio, as part of the Expanded Programme on Immunization (EPI). The World Health Assembly in 1988, in which Governments of over 100 countries including the Government of India resolved to eradicate polio, recognized Rotary International as the key non-government, private partner on the global team. Ever since Rotary has been providing financial assistance to national governments for the purchase of Oral Polio Vaccine and conducting the highest level of advocacy efforts to see that soon polio is eradicated globally. Rotary called its Polio Eradication Initiative" Polio Plus Program" and focused primarily on social mobilization and voluntarism.

Charities↗
PubMed2002

Extrapyramidal side effects of antipsychotic treatment: scope of problem and impact on outcome.

Previously, clinicians worked with antipsychotic drugs (conventional or typical) that almost invariably caused extrapyramidal symptoms (EPS) at clinically effective doses. This led to the false impression that all antipsychotics were the same, and that EPS were an unavoidable consequence of effective antipsychotic therapy. EPS adversely impact several aspects of antipsychotic efficacy and tolerability, thereby worsening outcome of afflicted individuals. EPS reduce beneficial effects of antipsychotic treatment on the negative, cognitive, and mood symptom domains, while increasing the risk of tardive dyskinesia and reducing compliance. By definition, the newer generation of "atypical" antipsychotic agents are significantly better than conventional agents with regard to EPS (i.e., they are clinically effective at doses at which they do not cause EPS). Pharmacologically, this difference is expressed in the greater degree of separation between respective dose response curves for antipsychotic and EPS effects observed for "atypical" in contrast to conventional agents. Clinically, this EPS advantage of atypical antipsychotics translates into several important benefits, including better negative symptom efficacy, less dysphoria, less impaired cognition, a lower risk of TD, and better overall outcome.

Antipsychotic Agents↗
PubMed2002

Safety and tolerability: how do newer generation "atypical" antipsychotics compare?

Previously, clinicians worked with antipsychotic drugs that almost invariably caused extrapyramidal side effects (EPS) at the dose at which they were clinically effective. By definition, all newer generation atypical antipsychotic agents are significantly better than conventional agents with regard to EPS; i.e., they are clinically effective at doses at which they do not cause EPS. This EPS advantage of atypical antipsychotics translates into several important clinical benefits, including better negative symptom efficacy, lesser dysphoria, less impaired cognition, and a lower risk of tardive dyskinesia; in fact, this "EPS advantage" is the principal basis of the many clinical advantages provided by the class of atypical antipsychotics. While all atypical agents share this "EPS advantage," there are important differences between these agents with regard to the ease and consistency with which this EPS advantage can be realized. Pharmacologically, different atypical antipsychotics differ; these differences translate into differences in their side effect profiles. Five atypical antipsychotics are currently available: clozapine, risperidone, olanzapine, quetiapine, and ziprasidone. Meaningful differences between these agents with regard to weight gain, sedation, anticholinergic side effects, cardiovascular issues, endocrine side effects, hepatic and sexual issues, will be considered and their clinical implications discussed.

Antipsychotic Agents↗
PubMed2002

Best clinical practice with ziprasidone: update after one year of experience.

This article presents clinical recommendations for using ziprasidone based on information from a year of post-marketing experience. The recommendations are based on the clinical literature, the package insert, presentations at recent meetings, data on file with the manufacturer, and the consensus of a panel of expert psychiatrists. The article provides updates on efficacy and safety data and gives recommendations for dosing and switching strategies. With regard to the QTc issue, there has not been any case of torsades de pointes reported in the more than 150,000 patients who have received ziprasidone since its approval. Ziprasidone is weight neutral and does not appear to cause increases in glucose or lipid levels or in insulin resistance. The panel generally recommends beginning with an initial dose of 80 mg/day (40 mg b.i.d.) rather than the 40 mg/day dose recommended in the package insert. The ability to begin with a therapeutic dose and to titrate up rapidly is an advantage of ziprasidone, especially in treatment settings where admission time is short. In making an elective switch to ziprasidone, the panel recommends a variety of different switching strategies but stresses the importance of trying to maintain a therapeutic dose of one antipsychotic at all times.

Journal Article↗
PubMed2002

Efficacy, safety, and tolerability of quetiapine in patients with schizophrenia.

Schizophrenia is a serious and disabling psychiatric disorder affecting approximately 1% of the world's population, with its economic cost in the United States alone estimated to exceed that of all cancers combined. The new generation of atypical antipsychotics introduced over the past decade have comparable or greater efficacy than traditional antipsychotics in treating the psychotic symptoms of schizophrenia and a much improved neurologic side effect profile. Quetiapine, the fourth atypical antipsychotic marketed in the United States, was approved by the U.S. Food and Drug Administration in September 1997 and is also currently approved in over 70 countries worldwide for the treatment of psychosis associated with schizophrenia. This article will review the clinical trials examining the efficacy, safety, and tolerability of quetiapine in the treatment of patients with schizophrenia.

Affect↗