An exploratory open‐label trial of aripiprazole as an adjuvant to clozapine therapy in chronic schizophrenia

Henderson, David C.; Kunkel, Laura; Nguyen, Dana; Borba, Christina P.C.; Daley, Tara B.; Louie, Pearl M.; Freudenreich, Oliver; Cather, Corrine; Evins, A. Eden; Goff, Donald C.

doi:10.1111/j.1600-0447.2005.00612.x

Cited by 111 publications

(78 citation statements)

References 32 publications

(27 reference statements)

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“…The relationship between adjunctive medications in clozapine-treated pediatric subjects and adverse metabolic side effects has not been adequately examined in pediatric subjects. There are some preliminary data in adults with schizophrenia that show the addition of aripiprazole to clozapine may be associated with a significant decrease in weight, BMI, fasting total serum cholesterol, and total triglycerides (Henderson et al 2006). Thus, this strategy needs to be explored in pediatric cases as it may target both clozapine-associated medical morbidity and residual symptoms.…”

Section: Week 12 a Week 24mentioning

confidence: 99%

Clozapine Versus “High-Dose” Olanzapine in Refractory Early-Onset Schizophrenia: An Open-Label Extension Study

Kumra

Kranzler

Gerbino-Rosen

et al. 2008

Journal of Child and Adolescent Psychopharmacology

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Objective: A recent 12-week controlled comparison demonstrated the superiority of clozapine to "high-dose" olanzapine in adolescents with treatment-refractory schizophrenia. In the present study, the authors conducted a 12-week, open-label, follow-up study to examine changes in lipid and glucose metabolism in youths maintained on clozapine and to determine whether patients who were previously randomized to high-dose olanzapine (up to 30 mg/day) responded to clozapine. Method: Thirty three (14 clozapine, 19 olanzapine) (85%) of 39 patients were available for the present 12-week, open-label extension study. Extended safety data using an intention-to-treat analysis from the 14 subjects treated with clozapine for a total of 24 weeks are presented. In addition, we report the clinical outcomes for 10 of 19 olanzapine-treated patients who were switched after 12 weeks to clozapine due to treatment nonresponse. Clinical response was defined as a decrease of 30% or more in total Brief Psychiatric Rating score from week 12 and a Clinical Global Impression-Improvement rating of 1 (very much improved) or 2 (much improved). Results: The incidence of hypertriglyceridemia (defined as fasting triglycerides Ͼ125 mg/dL) (10/14 ϭ 71%) and the incidence of "prediabetes" (defined as fasting blood glucose Ն100) (4/14 ϭ 29%) at week 24 in the clozapine-treated subjects were notable. Seven (70%) of 10 of young patients with schizophrenia who failed treatment with "high-dose" olanzapine were found to respond to a 12-week, open-label clozapine trial. Conclusions: Clinicians and caregivers need to be aware of potential metabolic adverse events of long-term clozapine treatment. Adolescents with a poor response to olanzapine may do better on clozapine. 307

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Section: Week 12 a Week 24mentioning

confidence: 99%

Clozapine Versus “High-Dose” Olanzapine in Refractory Early-Onset Schizophrenia: An Open-Label Extension Study

Kumra

Kranzler

Gerbino-Rosen

et al. 2008

Journal of Child and Adolescent Psychopharmacology

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“…The first of these was an open-label study of aripiprazole 15-30 mg daily added to clozapine (mean dose 455 mg/day) for 6 weeks in 13 people with chronic schizophrenia (Henderson et al, 2006). Eight people completed the trial and two withdrew at week 4.…”

Section: Use Of Adjunctive Aripiprazolementioning

confidence: 99%

BAP guidelines on the management of weight gain, metabolic disturbances and cardiovascular risk associated with psychosis and antipsychotic drug treatment

et al. 2016

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Excess deaths from cardiovascular disease are a major contributor to the significant reduction in life expectancy experienced by people with schizophrenia. Important risk factors in this are smoking, alcohol misuse, excessive weight gain and diabetes. Weight gain also reinforces service users' negative views of themselves and is a factor in poor adherence with treatment. Monitoring of relevant physical health risk factors is frequently inadequate, as is provision of interventions to modify these. These guidelines review issues surrounding monitoring of physical health risk factors and make recommendations about an appropriate approach. Overweight and obesity, partly driven by antipsychotic drug treatment, are important factors contributing to the development of diabetes and cardiovascular disease in people with schizophrenia. There have been clinical trials of many interventions for people experiencing weight gain when taking antipsychotic medications but there is a lack of clear consensus regarding which may be appropriate in usual clinical practice. These guidelines review these trials and make recommendations regarding appropriate interventions. Interventions for smoking and alcohol misuse are reviewed, but more briefly as these are similar to those recommended for the general population. The management of impaired fasting glycaemia and impaired glucose tolerance ('pre-diabetes'), diabetes and other cardiovascular risks, such as dyslipidaemia, are also reviewed with respect to other currently available guidelines.These guidelines were compiled following a consensus meeting of experts involved in various aspects of these problems. They reviewed key areas of evidence and their clinical implications. Wider issues relating to primary care/secondary care interfaces are discussed but cannot be resolved within guidelines such as these.

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“…68 We identified six noncontrolled observational studies that examined the relationship between antipsychotic polypharmacy and clinical outcomes in samples without documented treatment resistance to monotherapy (Table 2). [71][72][73][74][75][76] One study did not report on clinical outcomes. 71 Three of the studies evaluated the addition of a second antipsychotic to an existing antipsychotic 72,74,75 ; two studies found no improvement in symptoms, 72,75 while one study reported no clinical effects.…”

Section: Samples Without Established Treatment Resistance To Antipsycmentioning

confidence: 99%

“…[71][72][73][74][75][76] One study did not report on clinical outcomes. 71 Three of the studies evaluated the addition of a second antipsychotic to an existing antipsychotic 72,74,75 ; two studies found no improvement in symptoms, 72,75 while one study reported no clinical effects. 74 The remaining two studies had a different design, using regression analysis to assess the association between antipsychotic polypharmacy and premature death in patients with schizophrenia.…”

Section: Samples Without Established Treatment Resistance To Antipsycmentioning

confidence: 99%

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When Is Antipsychotic Polypharmacy Supported by Research Evidence? Implications for QI

Gören

Parks

Ghinassi

et al. 2008

The Joint Commission Journal on Quality and Patient Safety

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An exploratory open‐label trial of aripiprazole as an adjuvant to clozapine therapy in chronic schizophrenia

Abstract: This combination may be useful for clozapine-associated medical morbidity and must be studied in placebo-controlled double-blind randomized trials to determine efficacy and safety.

Cited by 111 publications

References 32 publications

Clozapine Versus “High-Dose” Olanzapine in Refractory Early-Onset Schizophrenia: An Open-Label Extension Study

Clozapine Versus “High-Dose” Olanzapine in Refractory Early-Onset Schizophrenia: An Open-Label Extension Study

BAP guidelines on the management of weight gain, metabolic disturbances and cardiovascular risk associated with psychosis and antipsychotic drug treatment

When Is Antipsychotic Polypharmacy Supported by Research Evidence? Implications for QI

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