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L Citrome

Publications and source records attributed to L Citrome.

At least 19 recordsLinked to original sources

Schizophrenia, Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) and number needed to treat: how can CATIE inform clinicians?

The schizophrenia medication study conducted as part of the Clinical Antipsychotic Trials of Intervention Effectiveness (CATIE) provided a large quantity of data. However, placing these data into a clinically meaningful context for the individual practitioner has been challenging. Effectiveness and safety outcome data were extracted from the three principal publications that documented the results of phases 1 and 2 of the CATIE schizophrenia study. Number needed to treat (NNT) and number needed to harm (NNH) were calculated from the categorical results, together with their confidence intervals. Olanzapine and clozapine demonstrated advantages over comparators in terms of all-cause discontinuation, largely driven by efficacy advantages. NNT for olanzapine compared with perphenazine, quetiapine, risperidone and ziprasidone ranged from 5.5 to 10.1 in phase 1. NNT for clozapine compared with risperidone or quetiapine was approximately 3 in phase 2. There were marked differences in association with weight gain and metabolic effects, with olanzapine demonstrating a NNH ranging from 12.4 to 17.7 in terms of discontinuation of treatment in phase 1 because of these effects. Results from phase 2 reflect phase 1 in this regard, and demonstrated an advantage for ziprasidone in terms of discontinuation because of weight gain or metabolic effects, with NNT ranging from 10.6 to 20.8. However, these notable differences in association with weight gain and metabolic effects did not seem to drive the differences in overall time to all-cause discontinuation. NNT and NNH can help place the wide array of CATIE results into clinical context, and permits quantification of the differences observed between the antipsychotics that were tested.

Antipsychotic Agents↗

Olanzapine for schizophrenia refractory to typical and atypical antipsychotics: an open-label, prospective trial.

The role of olanzapine in treatment-resistant schizophrenia is still unresolved. This article presents an open-label, prospective, 14-week trial with olanzapine in patients with schizophrenia and schizoaffective disorder selected for unambiguous resistance to either clozapine or risperidone and to typical antipsychotics. Forty-three inpatients (mean age, 41.6 years; mean duration of illness, 21.7 years) were enrolled and treated after cross-titration from their previous antipsychotic treatment with olanzapine 10 to 40 mg daily without any concomitant antipsychotic medication. Patients were evaluated with the Positive and Negative Syndrome Scale (PANSS), the Clinical Global Impressions Scale, and the Extrapyramidal Symptom Rating Scale. The change with olanzapine treatment was associated with a PANSS total score improvement of 3.7 (SD = 15.6; not significant). There was a significant improvement for the PANSS cognitive and depression/anxiety factors, whereas the PANSS excitement factor worsened. The improvement rate was superior in patients receiving olanzapine doses higher than 20 mg. A total of 16.7% of patients reached response criteria set forth by a previous study. There was a significant decrease in extrapyramidal side effects (t = 2.04; p < 0.05) and statistically significant, yet modest, weight gain. These results indicate that olanzapine is only modestly effective in these severely treatment-resistant patients with schizophrenia. However, a trial with olanzapine can be recommended in these patients before moving to augmentation strategies, given the lack of proven alternatives and the observation that 16.7% of patients reached the response criteria.

Adult↗

Effects of clozapine, olanzapine, risperidone, and haloperidol on hostility among patients with schizophrenia.

OBJECTIVE: This study compared the specific antiaggressive effects of clozapine with those of olanzapine, risperidone, and haloperidol. METHODS: A total of 157 inpatients with schizophrenia or schizoaffective disorder and a history of suboptimal treatment response were randomly assigned to receive clozapine, olanzapine, risperidone, or haloperidol in a double-blind 14-week trial. The trial was divided into two periods: eight weeks during which the dosage was escalated and then fixed, and six weeks during which variable dosages were used. The hostility item of the Positive and Negative Syndrome Scale (PANSS) was the principal outcome measure. Covariates included the items that reflect positive symptoms of schizophrenia (delusions, suspiciousness or feelings of persecution, grandiosity, unusual thought content, conceptual disorganization, and hallucinations) and the sedation item of the Nurses Observation Scale for Inpatient Evaluation (NOSIE). RESULTS: Patients differed in their treatment response as measured by the hostility item of the PANSS. The scores of patients taking clozapine indicated significantly greater improvement than those of patients taking haloperidol or risperidone. The effect on hostility appeared to be independent of the antipsychotic effect of clozapine on other PANSS items that reflect delusional thinking, a formal thought disorder, or hallucinations and independent of sedation as measured by the NOSIE. Neither risperidone nor olanzapine showed superiority to haloperidol. CONCLUSION: Clozapine has a relative advantage over other antipsychotics as a specific antihostility agent.

Adult↗

Changes in use of valproate and other mood stabilizers for patients with schizophrenia from 1994 to 1998.

OBJECTIVE: The study describes changes over time in the adjunctive use of valproate and other mood stabilizers-lithium, carbamazepine, and gabapentin--among hospitalized psychiatric patients with a diagnosis of schizophrenia. METHODS: For each calendar year from 1994 through 1998, data were drawn from a database containing clinical and drug prescription information for every inpatient in the adult civil facilities of the New York State Office of Mental Health. RESULTS: In 1994 a total of 26.2 percent of inpatients diagnosed as having schizophrenia received a mood stabilizer, compared with 43.4 percent in 1998. In 1994 lithium was the most commonly prescribed mood stabilizer, for 13.2 percent of patients, followed by valproate, for 12.3 percent. In 1998 valproate was the most commonly prescribed, for 35 percent of patients, followed by lithium, for 11.3 percent. On average, patients received valproate for about two-thirds of their hospital stay, at a mean dose of 1,520 mg per day. CONCLUSIONS: The adjunctive use of valproate nearly tripled from 1994 to 1998 among patients with a diagnosis of schizophrenia. Valproate has become the most commonly prescribed mood stabilizer for this population, despite the paucity of evidence in the literature for efficacy in this use. Controlled clinical trials are needed to examine the adjunctive use of mood stabilizers, in particular valproate, among patients with schizophrenia.

Acetates↗

Atypical antipsychotics in the treatment of the persistently aggressive psychotic patient: methodological concerns.

Aggressive behavior of psychotic patients impacts all aspects of their clinical care. Better treatments to address this problem are needed, and atypical antipsychotics, such as clozapine, risperidone, and perhaps quetiapine, have shown promise. However, studying the psychopharmacology of aggression is difficult because of the many methodological problems that arise in the design of appropriate clinical trials. These include imprecise definitions of aggression, the difficulty of measuring outcome because of the relative rarity of aggressive events, bias in the selection of patients for study, inadequate and inappropriate control groups, and inattention to comorbidities and concomitant medications in analyzing results. Since the usual outcome measure is the aggressive event rate, a large sample size and lengthy baseline and trial periods are required when this rate is low. Furthermore, formidable practical and ethical obstacles interfere with the many sound techniques (e.g. randomization) used in typical designs of psychopharmacological clinical trials. Current research methods should be modified and new ones developed in order to progress in assessing the antiaggressive effects of treatments.

Aggression↗

Violent patients in the emergency setting.

Violent or threatening behavior is a common reason for presentation to the ED. Patients with aggressive behavior must first be assessed for the possibility of comorbid medical conditions. Acute withdrawal from alcohol or sedatives needs to be ruled out. Short-term sedation with lorazepam is a safe and effective choice for managing patients with acute agitation. The use of typical neuroleptics may lead to side effects, such as akathisia, which may in turn precipitate additional agitation. This may be obviated with the introduction of IM preparations of atypical antipsychotics.

Antipsychotic Agents↗

Utilization of valproate: extent of inpatient use in the New York State Office of Mental Health.

OBJECTIVE: To describe the extent and type of use of valproate among hospitalized psychiatric patients. METHOD: A database containing patient information and drug prescription information for every in-patient within the adult civil facilities of the New York State Office of Mental Health was queried. RESULTS: In 1994, 2,888 of 18,668 in-patients received valproate (15.5%). In 1996, 4,247 of 12,444 in-patients received valproate (34.1%). In 1996, approximately 50% of all patients diagnosed as bipolar or schizoaffective, and 28% of all patients diagnosed with schizophrenia, received valproate. Once started on valproate, over 90% remained on it after 2 weeks, with no difference found in the discontinuation rates between valproic acid or divalproex sodium at the end of the initial 14 day period. Patients received valproate for approximately two-thirds of their hospital stay, at a mean dose of 1400 mg/day. 95% also received concomitant antipsychotics, and 20% received concomitant lithium. Use of lithium and carbamazepine was less in 1996 than in 1994, but the magnitude of this change was much less than the increase in utilization of valproate. CONCLUSIONS: From 1994 to 1996 valproate use has more than doubled, and it is being used widely in patients with schizophrenia, an off-label indication for which there is only anecdotal support in the literature. Given the lack of difference in early discontinuation rates, there are probably no dramatic differences in side effects for the two preparations of valproate.

Adult↗

Practice protocols, parameters, pathways, and guidelines: a review.

The evolution of clinical practice protocols is described within the context of its origins in utilization review and utilization management. Physician concerns and barriers to implementation, as well as the role of the Agency for Health Care Policy and Research (AHCPR) are discussed. An example of competing guidelines from the AHCPR and the American Psychiatric Association is described in detail. The available literature on cost savings related to utilization management and clinical guidelines is reviewed and summarized. With over 1,800 medical practice guidelines catalogued, practice protocols have become ubiquitous and continued research into their cost and impact on quality are needed.

Attitude of Health Personnel↗

New antipsychotic medications: what advantages do they offer?

New, so-called atypical antipsychotic medications will no doubt supplant the traditional, or "typical," antipsychotic medications, just as the new generation of antidepressant agents has replaced the older tricyclic drugs. At issue with most of the new drugs is not acute efficacy, but long-term tolerability. Side effects must be minimized to enhance compliance and prevent relapse. It appears that many of the new antipsychotic drugs have fewer or less troublesome side effects than the older agents. In addition, the "atypical" antipsychotic agents hold promise for treating refractory schizophrenia. At present, only clozapine, with its risks for agranulocytosis and seizures, is clearly established as a treatment for refractory illness. Risperidone may be an alternative for treatment-resistant schizophrenia, but this has not yet been clearly proved. Olanzapine has recently been introduced. Sertindole should be available soon, and quetiapine and ziprasidone should quickly follow. Safety, efficacy, and cost will guide their use. None of these newer agents have been compared head-to-head with clozapine. More research is needed to place these new drugs into clinical perspective.

Antipsychotic Agents↗

Adjunctive nadolol in the treatment of acutely aggressive schizophrenic patients.

BACKGROUND: This study assessed the safety and efficacy of nadolol 120 mg/day compared with placebo, when administered adjunctively to neuroleptic in a group of acutely aggressive schizophrenic patients. METHOD: Thirty-four male patients enrolled in this double-blind, placebo-controlled trial. The subjects were evaluated with the Brief Psychiatric Rating Scale (BPRS) and the Simpson Angus Neurologic Rating Scale for extrapyramidal effects. The total BPRS score as well as three factors, thought disturbance, hostility, and activation, was analyzed. RESULTS: Compared with those who received placebo, the patients taking nadolol showed significant improvement on total BPRS score, particularly on the thought disturbance and activation factors, after the first treatment week (p = .05). By the end of the second treatment week, the patients taking placebo also began to show improvement, and the group differences were no longer significant. The patients treated with nadolol showed significantly more improvement on Simpson-Angus scores than those who received placebo (p = .03). However, there was no significant correlation between BPRS and Simpson-Angus changes. In the nadolol group, patients with and without akathisia showed no significant difference in their BPRS scores. CONCLUSION: These findings suggest that adjunctive nadolol may be useful in the treatment of acutely aggressive schizophrenic patients by inducing a more rapid and consistent decrease of overall psychiatric symptoms and by reducing the extrapyramidal effects. Our results raise the possibility that the mechanism of action of nadolol on psychiatric symptoms in schizophrenic patients may be different from the mechanism of improvement of neuroleptic-induced extrapyramidal symptoms and akathisia. Nadolol may be a helpful adjunctive treatment for schizophrenic patients in general and not just for those with a high hostility level.

Acute Disease↗

Utilization of depot neuroleptic medication in psychiatric inpatients.

This report describes the extent and pattern of use of depot neuroleptics within the 21 adult civil psychiatric hospitals operated by the New York State Office of Mental Health (OMH). All inpatients receiving depot or oral neuroleptics in calendar year 1994 were identified. In addition to descriptive data on admission and drug orders, a logistic regression was fit using gender, age, race, and facility for the probability of receiving depot. Depot utilization ranged from 12 percent to 39 percent of all patients receiving neuroleptics (N = 18,543). Differences among facilities were statistically significant (p < .05). Gender was not found to be a statistically significant factor, but blacks and Hispanic/others were found to be more likely than whites to receive depot (p < .05), and those 65 years or older were found to be less likely to receive depot (p < .05). For patients admitted in 1994, depot neuroleptics were typically started within a month or two of admission and continued for 2 to 3 months, with 86 percent of these patients discharged by December 31, 1995. Except for milligram dose and frequency of injection, haloperidol decanoate and fluphenazine decanoate did not differ in terms of extent and pattern of use.

Adult↗

Clinical and administrative consequences of a reduced census on a psychiatric intensive care unit.

The Psychiatric Intensive Care Unit at the FDR VA Hospital is a specialized ward designed to assess and treat suicidal and assaultive patients. Since its creation in 1983, over 1600 admissions have taken place. The authors have previously reported that patients referred for aggressive behavior had a statistically significant higher recidivism rate, as well as a statistically significant longer length of stay. The unit went through several changes in response to externally perceived needs and available resources. When the census cap was decreased, the referral pattern changed and the patients were even more likely to be aggressive. Length of stay decreased dramatically leading to a unit with a significantly higher turnover rate. Clinical and administrative concerns are also discussed.

Aggression↗