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The efficacy and safety of once-daily quetiapine extended release in patients with schizophrenia switched from other antipsychotics: an open-label study in Chinese population.

Pan PY, Lee MS, Yeh CB - BMC Psychiatry (2015)

Bottom Line: The use of concomitant anticholinergics decreased from 15.0% to 8.3%.The results of our investigation implicated that quetiapine XR was an effective and well tolerated alternative for Chinese schizophrenic patients with previous suboptimal treatment.Future large-scale studies are warranted to validate our results.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, No.325, Sec.2,Chenggong Rd., Neihu Dist., Taipei City, 114, Taiwan. pan-peiyin@mail.ndmctsgh.edu.tw.

ABSTRACT

Background: Non-adherence to antipsychotic medication in schizophrenic patients is common and associated with symptom relapse and poorer long-term outcomes. The risk factors for treatment non-adherence include dosing frequency and complexity. Besides, slower dose titration in an acute schizophrenic episode may lead to attenuated efficacy. Therefore, the convenient dosage regimen and rapid initiation scheme of quetiapine extended release (XR) were expected to provide better effectiveness and promote adherence in patients with schizophrenia. This study was implemented to assess the efficacy and safety of once-daily quetiapine XR in schizophrenic patients with switched from other antipsychotics which were suboptimal due to insufficient efficacy or tolerability.

Methods: This was a 12-week, open-label study conducted in the Chinese population in Taiwan. Patients who had a score of 4 (moderate) or greater on any of the 7 items of the Positive and Negative Syndrome Scale (PANSS) Positive Symptom Subscale and needed to switch from previous antipsychotics were recruited. Quetiapine XR was administered at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within 400-800 mg per day, depending on the clinical response and tolerance of the patients. The variable of the primary outcome was the change from baseline to Week 12 in PANSS total and subscale scores. Secondary outcome was the baseline-to-endpoint difference in the Clinical Global Impression-Severity (CGI-S) scores of the participants.

Results: Sixty-one patients were recruited and 55.7% of them completed the study. The mean changes in the PANSS total score and CGI-S score showed significant improvement (-18.4, p < .001 and -1.0, p < .001, respectively). Four patients (6.7%) experienced adverse events including headache, exacerbation of psychosis and dysuria. The use of concomitant anticholinergics decreased from 15.0% to 8.3%.

Conclusions: The results of our investigation implicated that quetiapine XR was an effective and well tolerated alternative for Chinese schizophrenic patients with previous suboptimal treatment. Future large-scale studies are warranted to validate our results.

Trial registration: ClinicalTrials.gov ID NCT02142556 . Registered 15 May 2014.

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Related in: MedlinePlus

The study design and schematic diagram of switching from other antipsychotics to quetiapine XR in this investigation.aAfter day 2, the dosage of quetiapine XR was allowed up to 800 mg. From day 8 until week 12, the dose of quetiapine XR was adjusted within the effective dose range of 400 mg to 800 mg per day.
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Fig1: The study design and schematic diagram of switching from other antipsychotics to quetiapine XR in this investigation.aAfter day 2, the dosage of quetiapine XR was allowed up to 800 mg. From day 8 until week 12, the dose of quetiapine XR was adjusted within the effective dose range of 400 mg to 800 mg per day.

Mentions: This study was a 12-week, open-label investigation conducted in the Chinese population in Taiwan (November 2008 to March 2012). The treatment was initiated with a 7-day cross-titration period. Previous antipsychotic medication was maintained at the original dose from day 1 to day 3; then reduced to 50% of the original dose from day 4 to day 7 and discontinued on day 8. Meanwhile, the patients started the study medication with a daily dose of 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study (treatment period), the dose of study medication was adjusted within the effective dose range of 400 mg to 800 mg per day, depending on the clinical response and tolerance of the patient. The administration of any other antipsychotics or psychoactive medications was prohibited during the treatment period. Patients treated with quetiapine IR preceding enrollment were direct switched to the equivalent dose of quetiapine XR. The dose and treatment regimen of this study are shown in Figure 1.Figure 1


The efficacy and safety of once-daily quetiapine extended release in patients with schizophrenia switched from other antipsychotics: an open-label study in Chinese population.

Pan PY, Lee MS, Yeh CB - BMC Psychiatry (2015)

The study design and schematic diagram of switching from other antipsychotics to quetiapine XR in this investigation.aAfter day 2, the dosage of quetiapine XR was allowed up to 800 mg. From day 8 until week 12, the dose of quetiapine XR was adjusted within the effective dose range of 400 mg to 800 mg per day.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4308905&req=5

Fig1: The study design and schematic diagram of switching from other antipsychotics to quetiapine XR in this investigation.aAfter day 2, the dosage of quetiapine XR was allowed up to 800 mg. From day 8 until week 12, the dose of quetiapine XR was adjusted within the effective dose range of 400 mg to 800 mg per day.
Mentions: This study was a 12-week, open-label investigation conducted in the Chinese population in Taiwan (November 2008 to March 2012). The treatment was initiated with a 7-day cross-titration period. Previous antipsychotic medication was maintained at the original dose from day 1 to day 3; then reduced to 50% of the original dose from day 4 to day 7 and discontinued on day 8. Meanwhile, the patients started the study medication with a daily dose of 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study (treatment period), the dose of study medication was adjusted within the effective dose range of 400 mg to 800 mg per day, depending on the clinical response and tolerance of the patient. The administration of any other antipsychotics or psychoactive medications was prohibited during the treatment period. Patients treated with quetiapine IR preceding enrollment were direct switched to the equivalent dose of quetiapine XR. The dose and treatment regimen of this study are shown in Figure 1.Figure 1

Bottom Line: The use of concomitant anticholinergics decreased from 15.0% to 8.3%.The results of our investigation implicated that quetiapine XR was an effective and well tolerated alternative for Chinese schizophrenic patients with previous suboptimal treatment.Future large-scale studies are warranted to validate our results.

View Article: PubMed Central - PubMed

Affiliation: Department of Psychiatry, Tri-Service General Hospital, National Defense Medical Center, No.325, Sec.2,Chenggong Rd., Neihu Dist., Taipei City, 114, Taiwan. pan-peiyin@mail.ndmctsgh.edu.tw.

ABSTRACT

Background: Non-adherence to antipsychotic medication in schizophrenic patients is common and associated with symptom relapse and poorer long-term outcomes. The risk factors for treatment non-adherence include dosing frequency and complexity. Besides, slower dose titration in an acute schizophrenic episode may lead to attenuated efficacy. Therefore, the convenient dosage regimen and rapid initiation scheme of quetiapine extended release (XR) were expected to provide better effectiveness and promote adherence in patients with schizophrenia. This study was implemented to assess the efficacy and safety of once-daily quetiapine XR in schizophrenic patients with switched from other antipsychotics which were suboptimal due to insufficient efficacy or tolerability.

Methods: This was a 12-week, open-label study conducted in the Chinese population in Taiwan. Patients who had a score of 4 (moderate) or greater on any of the 7 items of the Positive and Negative Syndrome Scale (PANSS) Positive Symptom Subscale and needed to switch from previous antipsychotics were recruited. Quetiapine XR was administered at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within 400-800 mg per day, depending on the clinical response and tolerance of the patients. The variable of the primary outcome was the change from baseline to Week 12 in PANSS total and subscale scores. Secondary outcome was the baseline-to-endpoint difference in the Clinical Global Impression-Severity (CGI-S) scores of the participants.

Results: Sixty-one patients were recruited and 55.7% of them completed the study. The mean changes in the PANSS total score and CGI-S score showed significant improvement (-18.4, p < .001 and -1.0, p < .001, respectively). Four patients (6.7%) experienced adverse events including headache, exacerbation of psychosis and dysuria. The use of concomitant anticholinergics decreased from 15.0% to 8.3%.

Conclusions: The results of our investigation implicated that quetiapine XR was an effective and well tolerated alternative for Chinese schizophrenic patients with previous suboptimal treatment. Future large-scale studies are warranted to validate our results.

Trial registration: ClinicalTrials.gov ID NCT02142556 . Registered 15 May 2014.

Show MeSH
Related in: MedlinePlus