Safety and efficacy of olanzapine treatment in psychosis: Effect of genetic and epigenetic factors – covariates of treatment response

Conditions

Psychoses

Brief summary

Frequency of gene polymorphisms of CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC3 and HDAC4

Detailed description

Cytosine methylation of 5HT2A, Metabolic phenotype of CYP1A2, Response rate: The treatment response is defined as 20% reduction in PANSS score (see Chapter 7.2) on day 14 or 30% reduction in PANSS score on day 28 compared to baseline score., Remission rate: Remission is defined in compliance with the “Remission in Schizophrenia Working Group” as reduction of the severity of symptoms evaluated in items P1, P2, P3, G5, G9, N1, N4, N6 of PANSS scale to ≤ 3 degree; with respect to the study period, although the original recommended time factor (6 months) will not be included in the evaluation., Time to reach the treatment response (i.e., 20% reduction in PANSS score)., Number of "drop-outs" (olanzapine treatment cessation) and their reasons., Side effects assessment: UKU scale (see Chapter 8.3), Treatment of the adverse effects of olanzapine – medication, doses, treatment duration, changes in olanzapine administration.

Related papers

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Interventions

DRUGOLANZAPINE

Eligibility

Sex/Gender

All

Age

18 Years to 64 Years

Design outcomes

Primary

Measure	Time frame
Frequency of gene polymorphisms of CYP1A2, MDR1, 5HT2A, 5HT2C, HDAC3 and HDAC4	—

Secondary

Measure	Time frame
Cytosine methylation of 5HT2A, Metabolic phenotype of CYP1A2, Response rate: The treatment response is defined as 20% reduction in PANSS score (see Chapter 7.2) on day 14 or 30% reduction in PANSS score on day 28 compared to baseline score., Remission rate: Remission is defined in compliance with the “Remission in Schizophrenia Working Group” as reduction of the severity of symptoms evaluated in items P1, P2, P3, G5, G9, N1, N4, N6 of PANSS scale to ≤ 3 degree; with respect to the study period, although the original recommended time factor (6 months) will not be included in the evaluation., Time to reach the treatment response (i.e., 20% reduction in PANSS score)., Number of "drop-outs" (olanzapine treatment cessation) and their reasons., Side effects assessment: UKU scale (see Chapter 8.3), Treatment of the adverse effects of olanzapine – medication, doses, treatment duration, changes in olanzapine administration.	—

Measure

Time frame

Cytosine methylation of 5HT2A, Metabolic phenotype of CYP1A2, Response rate: The treatment response is defined as 20% reduction in PANSS score (see Chapter 7.2) on day 14 or 30% reduction in PANSS score on day 28 compared to baseline score., Remission rate: Remission is defined in compliance with the “Remission in Schizophrenia Working Group” as reduction of the severity of symptoms evaluated in items P1, P2, P3, G5, G9, N1, N4, N6 of PANSS scale to ≤ 3 degree; with respect to the study period, although the original recommended time factor (6 months) will not be included in the evaluation., Time to reach the treatment response (i.e., 20% reduction in PANSS score)., Number of "drop-outs" (olanzapine treatment cessation) and their reasons., Side effects assessment: UKU scale (see Chapter 8.3), Treatment of the adverse effects of olanzapine – medication, doses, treatment duration, changes in olanzapine administration.

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Countries

Czechia

Outcome results

None listed