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ACAD 2H 2019 va a ser clave. Resultados en indicaciones 10x a las actuales y

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ACAD

2H 2019 va a ser clave. Resultados en indicaciones 10x a las actuales y con buenas opciones como es DRP (y MDD es tan grande que con repetir la fase 2 podría rascar algo también). Ver página 5 de la presentación de JMP19.

En este artículo (pagado por ACAD) explica el potencial para RDP y el estudio que se está llevando a cabo, un extracto:

"There are several advantages of the relapse prevention design of this study. First, it maximizes the duration of exposure to a potentially effective treatment (pimavanserin) and minimizes the duration of exposure to placebo ( 5556). A second advantage is the enrichment of the study population with an open-label, run-in phase, which helps to minimize inclusion of non-responders. Also, Brief Psychosocial Therapy will be used at screening to eliminate patients who respond to non-pharmacological therapies, ensuring that most patients in need, receive pharmacological treatment. In addition, the withdrawal design affords the advantage of offering potentially therapeutic medication to all participants at enrollment, making it more feasible to enroll persons with active psychosis who might otherwise be unwilling or unable to consider trial participation. This addresses a major barrier to enrollment in trials when treatment is perceived as most necessary. Similar designs have been used successfully with a number of antipsychotics and antidepressants to demonstrate long-term efficacy and safety in a range of psychiatric indications (57). This design is aligned with 2017 American Psychiatric Association guidelines for use of antipsychotic drugs in dementia patients: if a drug demonstrates no efficacy after 4–6 weeks, therapy should be discontinued. If a drug demonstrates efficacy within 16 weeks, an attempt should be made to taper off medication to determine if ongoing therapy is necessary."

 

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