A Clinical Study of Clozapine Treatment and Predictors of Response in a Canadian Sample

Objective To study the clinical response to clozapine in patients with refractory schizophrenia. Method Open trial of clozapine in 61 consecutively-treated patients. Results Following clozapine, the level of function of patients was improved relative to admission (p = 0.0001) and to the highest level in the previous year (p = 0.0001). Severity of illness was decreased (p = 0.0001). Overall, 31% of the patients were classified as responders to clozapine and the responders were all identified by 32 weeks of treatment. Poor functioning in the previous year was associated with less favourable response. At a mean interval of 26 months following discharge, 72% of the patients were continuing clozapine treatment. Conclusions This open trial of patients who were treated consecutively indicates a comparable degree of response to clozapine as observed in controlled clinical trials, and that level of functioning in the previous year was the best predictor of response.

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Pharmacological management of treatment-resistant schizophrenia: fundamentals of clozapine

10.1093/med/9780198828761.003.0006 ◽

2018 ◽

Author(s):

Yvonne Yang ◽

Stephen Marder

Keyword(s):

Clinical Trials ◽

Weight Gain ◽

Side Effects ◽

Plasma Concentrations ◽

Psychotic Symptoms ◽

Controlled Clinical Trials ◽

Treatment Resistant ◽

Minimum Duration ◽

Pharmacological Management ◽

Clozapine Treatment

Evidence from controlled clinical trials supports the prescribing of clozapine for patients with treatment-resistant schizophrenia (TRS). Early studies focused on severely ill TRS patients. More recent studies indicate that clozapine can be effective for patients who are relatively stable but are burdened by persistent psychotic symptoms. Clozapine treatment is associated with a substantial side effect burden, including sedation, orthostasis, weight gain, constipation, and seizures. In addition, because of a risk of potentially fatal agranulocytosis, clozapine patients require regular monitoring of their neutrophil count. Measuring clozapine plasma concentrations can be helpful in managing patients with severe side effects and those with an inadequate clinical response. A trial of clozapine should consist of a minimum duration of 12 weeks.

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Psychotherapy research ethics: Continuing the debate on controlled clinical trials.

American Psychologist ◽

10.1037/0003-066x.42.10.956.b ◽

1987 ◽

Vol 42 (10) ◽

pp. 956-957 ◽

Cited By ~ 2

Author(s):

Craig A. Heflinger

Keyword(s):

Clinical Trials ◽

Research Ethics ◽

Psychotherapy Research ◽

Controlled Clinical Trials

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A rejoinder to "Psychotherapy research ethics: Continuing the debate on controlled clinical trials."

American Psychologist ◽

10.1037/0003-066x.42.12.1132 ◽

1987 ◽

Vol 42 (12) ◽

pp. 1132-1133

Author(s):

Stanley D. Imber ◽

Lawrence M. Glanz ◽

Irene Elkin ◽

Stuart M. Sotsky ◽

Jenny L. Boyer ◽

...

Keyword(s):

Clinical Trials ◽

Research Ethics ◽

Psychotherapy Research ◽

Controlled Clinical Trials

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The Advancement of Controlled Clinical Trials

PsycEXTRA Dataset ◽

10.1037/e715772007-001 ◽

2007 ◽

Author(s):

Linda Bren

Keyword(s):

Clinical Trials ◽

Controlled Clinical Trials

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A Multivariate Approach to Analyze Ordinal Data Collected in Clinical Trials of Analgesic Agents

Methods of Information in Medicine ◽

10.1055/s-0038-1636462 ◽

1979 ◽

Vol 18 (03) ◽

pp. 175-179

Author(s):

E. Mabubini ◽

M. Rainisio ◽

V. Mandelli

Keyword(s):

Clinical Trials ◽

Multivariate Analysis ◽

Analgesic Effect ◽

Ordinal Data ◽

Ordinal Scale ◽

Multivariate Approach ◽

Controlled Clinical Trials ◽

Second Stage ◽

Analgesic Agents ◽

Relevant Factors

After pointing out the drawbacks of the approach commonly used to analyze the data collected in controlled clinical trials carried out to evaluate the analgesic effect of potential agents, the authors suggest a procedure suitable for analyzing data coded according to an ordinal scale. In the first stage a multivariate analysis is carried out on the codec! data and the projection of each result in the space of the most relevant factors is obtained. In the second stage the whole set of these values is processed by distribution-free tests. The procedure has been applied to data previously published by VENTAITBIDDA et al. [18].

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