The Efficacy and Safety of Quetiapine XR in Patients With Schizophrenia Switched From Other Antipsychotics
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|ClinicalTrials.gov Identifier: NCT02142556|
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : May 20, 2014
Purpose To evaluate the efficacy and safety of once-daily quetiapine extended release (XR) in patients with schizophrenia switched from other antipsychotics which were suboptimal due to insufficient efficacy or insufficient tolerability.
This was a 12-week, open-label study conducted in the Chinese population in Taiwan. Quetiapine XR was administrated 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 tolerability of the patients.
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia||Drug: Administration of quetiapine XR||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Efficacy and Safety of Once-daily Quetiapine Extended Release in Patients With Schizophrenia Switched From Other Antipsychotics|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||March 2012|
|Actual Study Completion Date :||March 2012|
Experimental: Quetiapine XR
Patients had schizophrenia and fulfilled the criteria including having 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 due to insufficient efficacy or insufficient tolerability (N=61). They will receive the intervention of administration of quetiapine XR.
Drug: Administration of quetiapine XR
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 quetiapine XR with daily dose 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 tolerability of the patients.
- Efficacy Assessments [ Time Frame: 12 weeks ]The variable of the primary endpoint was the change from baseline to Week 12 in PANSS total and subscale score.
- Safety Assessments [ Time Frame: 12 weeks ]The occurrence and severity of adverse events (AEs) will be recorded throughout the study to assess the tolerability of quetiapine XR, including AEs spontaneously reported by the patients or observed by the staff.
- Other Safety Assessments-the measure is a composite for metabolic disturbance [ Time Frame: 12 weeks ]The patient's vital signs and body weight will be measured at screening and every visit schedule (week 1, 2, 4, 8, 12). An electrocardiogram and laboratory measurements including hematology and glycosylated hemoglobin (HbA1c) will be performed at enrolment and week 12.
- Another efficacy assessment-CGI-S [ Time Frame: 12 weeks ]Another efficacy endpoint was the difference from baseline to the end of study in Clinical Global Impression-Severity (CGI-S) score in the participants.
- other safety assessments-the measure is a composite for EPS [ Time Frame: 12 weeks ]Other scales used to evaluate the extrapyramidal symptoms (EPS) associated with the previous antipsychotics or quetiapine XR were Abnormal Involuntary Movement Scale (AIMS), Barnes-Akathisia Rating scale (BARS) and Simpson-Angus Scale (SAS). The use of anticholinergic medications during the treatment period will also be recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142556
|Tri-Service General Hospital, National Defense Medical Center|
|Taipei, Taiwan, 114|
|Principal Investigator:||Chin-Bin Yeh, M.D., Ph.D.||Tri-Service General Hospital, National Defense Medical Center|