Amisulpride and olanzapine followed by open-label treatment with clozapine in first-episode schizophrenia and schizophreniform disorder (OPTiMiSE): a three-phase switching study

Rossum, Inge Winter van; Kapur, Shitij; Kahn, René S.; Sommer, Iris; Rossum, Inge Winter-van; Somers, Metten; Ywema, Paula C; Kapur, S.; McGuire, Philip; Leboyer, Marion; Meyer‐Lindenberg, Andreas; Lewis, Shôn; Leucht, Stefan; Arango, Celso; Fleischhacker, W. Wolfgang; Meijering, Anne Lotte; Petter, Jocelyn; Brug, Resy van de; Schotsman, Joost; Zwerver, Jildou; Peuskens, J.; Hert, Marc De; Thys, E; Hranov, Lucho G; Hranov, Valentin; Libiger, Jan; Köhler, Richard; Mohr, Pavel; Glenthøj, Birte; Broberg, Brian Villumsen; Düring, Signe; Baandrup, Lone; Jamain, Stéphane; Heres, Stephan; Rujescu, Dan; Giegling, Ina; Weiser, Mark; Heim, M; Davidson, Michael; Galderisi, Silvana; Bucci, Paola; Mucci, Armida; Rybakowski, Janusz; Remlinger-Molenda, Agnieszka; Gonen, Ilan; Radu, Paull; Dı́az-Marsá, Marina; Rodríguez, Alberto González; Palomo, Tomás; Rodríguez‐Jiménez, Roberto; García‐Portilla, Paz; Bernardo, Miquel; Bobes, Julio; Oliveira, Christina Vilares; Berger, Gregor; Wildt, Claudia; Dazzan, Paola; Perez-Iglesias, Roccio; Drake, Richard; Gregory, Sarah; Wilson, Danielle; Díaz‐Caneja, Covadonga M.; Eijkemans, Marinus J.C.

doi:10.1016/s2215-0366(18)30252-9

Cited by 161 publications

(122 citation statements)

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“…This case report highlights the importance of clozapine for nonresponding patients in early stages of disease. Kahn et al [78] recently suggested that clozapine should be used after patients fail a single antipsychotic trial rather than after two different antipsychotics have been tried, as in the current recommendations. Clozapine may also exert a neuroprotective effect by restoring white matter integrity as described in our recently published study [79].…”

Section: Discussionmentioning

confidence: 99%

Dandy-Walker Malformation-Like Condition Revealed by Refractory Schizophrenia: A Case Report and Literature Review

et al. 2018

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Introduction: Dandy-Walker malformation is a rare congenital malformation involving cystic dilatation of the fourth ventricle, enlarged posterior fossa, complete or partial agenesis of the cerebellar vermis, elevated tentorium cerebelli, and hydrocephalus. Previous research highlighted a possible role for the cerebellum in schizophrenia as well as the contribution of underlying brain malformations to treatment resistance. Here, we present a case of a Dandy-Walker malformation-like condition revealed by a refractory schizophrenia in a 24-year-old male patient. We also conduct a literature review of all previously published case reports or case series of co-occurring posterior fossa abnormalities and schizophrenia or psychosis using a PubMed search query to better understand the potential link between these two disorders. Case Presentation: A 9-month hospital stay was needed to address the treatment-resistant psychotic symptoms, and the patient continued to experience moderate symptoms despite the prescription of various antipsychotic and antidepressant medications. After an irregular initial medical follow-up, the patient is currently treated with 350 mg daily clozapine and 20 mg daily prazepam and still exhibits moderate anxiety without delirious thoughts, however allowing him to re-enroll at the university. Regarding the literature, 24 cases published between 1996 and 2017 were identified, reviewed and compared to the present case report. Discussion: This case report and literature review further illuminates the pathophysiology of psychotic disorders including the potential role of the cerebellum, reinforces the importance of a multidisciplinary approach for the neurological and psychiatric management of patients with schizophrenia, and highlights optimal pharmacological management strategies for treatment-resistant schizophrenia.

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Section: Discussionmentioning

confidence: 99%

Dandy-Walker Malformation-Like Condition Revealed by Refractory Schizophrenia: A Case Report and Literature Review

et al. 2018

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“…non-clozapine) antipsychotic in the UK. It was decided that a stratifier would be more useful for patients who failed a first-line conventional antipsychotic than patients who are treatment-naïve, because the latter patient group has a high response rate to first-line conventional antipsychotic (ranges from 67.4 to 75.4% as reported by published literature [13,14]).…”

Section: Populationmentioning

confidence: 99%

“…There is a lack of clinical evidence about patients' response to a second-line antipsychotic after failing a first-line antipsychotic. According to a recent literature review [14], there are only two trials which examined patients' response to a second-line antipsychotic after failing a first-line antipsychotic: one is a naturalistic study conducted by Agid et al [13], and another is an openlabel treatment with clozapine in first-episode schizophrenia and schizophreniform disorder (OPTiMiSE) trial [14]. It was decided that the data reported by Agid et al is more appropriate for this model for two reasons: (1) Agid et al has a larger sample size than the OPTiMiSE trial (60 vs 39, number of patients who were switched to a second-line antipsychotic after failing a first-line antipsychotic); (2) The results of the OPTiMiSE trial indicated that for patients who did not achieve remission with a first-line antipsychotic within 4 weeks, switching to a second-line conventional antipsychotic did not improve their response rate-or in another word, for patients who failed a first-line antipsychotic, the proportion of AP2 responder is nearly zero.…”

Section: Input Datamentioning

confidence: 99%

“…According to a recent systematic review [14], there are only two trials which examined patients' response to a second-line antipsychotic after failing a first-line antipsychotic: Agid et al [13] and the OPTiMiSE trial [14]. Both studies found that for patients who failed a first-line conventional antipsychotic, their response to a second-line conventional antipsychotic is poor-in fact, the OPTiMiSE trial found that for patients who did not achieve remission with a firstline antipsychotic within 4 weeks, it might be better for them to continue their current antipsychotic, rather than being switched to a second-line conventional antipsychotic.…”

Section: Main Findings and Interpretationmentioning

confidence: 99%

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Stratified Medicine in Schizophrenia - How Accurate Would a Test of Drug Response Need to Be to Achieve Cost-Effective Improvements in Quality of Life?

2018

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Objective Stratified medicine refers to the use of tests that predict treatment response to drive treatment decisions for individual patient. The pharmacoeconomic implications of this approach in schizophrenia are unknown. We aimed to assess the cost-effectiveness of a hypothetical stratified medicine algorithm (SMA) compared with treatment as usual (TAU), for patients with schizophrenia who failed a first-line antipsychotic.Methods A decision analytic model with embedded Markov process was constructed, which simulated the health and cost outcomes for patients followed SMA or TAU over a lifetime horizon, from healthcare and social care perspective. In the basecase analysis, sensitivity and specificity of the stratifier were both set as 60%. Extensive sensitivity analyses were conducted to test the impact of uncertainty around the value of important parameters. The primary outcome was the incremental cost per quality-adjusted life year (QALY) gained. Results When both sensitivity and specificity of the stratified test were set at 60%, SMA appeared to be the optimal strategy as it produces more QALYs and incurs lower costs than TAU. This is robust to all scenarios tested. At a willingness-to-pay threshold of £20,000 per QALY, the probability for SMA to be the optimal strategy is 82.4%. Conclusions Our results suggest that use of any stratifier with a sensitivity and specificity over 60% is very likely to be costeffective comparing to TAU, for psychotic patients who failed a first-line antipsychotic. This finding, however, should be interpreted with caution due to lack of evidence for clozapine as a second-line antipsychotic.

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“…While the current evidence is promising, well‐designed and well‐powered RCTs in patients with early‐phase schizophrenia will be needed to establish whether clozapine may indeed improve clinical outcome and quality of life. Indeed, a recent example of such a trial suggests that clozapine may have a role in a simple treatment algorithm for early‐stage schizophrenia .…”

mentioning

confidence: 99%

Clozapine as an early‐stage treatment

Homan

Kane

2018

Acta Psychiatr Scand

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Amisulpride and olanzapine followed by open-label treatment with clozapine in first-episode schizophrenia and schizophreniform disorder (OPTiMiSE): a three-phase switching study

Abstract: European Commission Seventh Framework Program.

Cited by 161 publications

References 24 publications

Dandy-Walker Malformation-Like Condition Revealed by Refractory Schizophrenia: A Case Report and Literature Review

Dandy-Walker Malformation-Like Condition Revealed by Refractory Schizophrenia: A Case Report and Literature Review

Stratified Medicine in Schizophrenia - How Accurate Would a Test of Drug Response Need to Be to Achieve Cost-Effective Improvements in Quality of Life?

Clozapine as an early‐stage treatment

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