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The Efficacy and Safety of Quetiapine XR in Patients With Schizophrenia Switched From Other Antipsychotics

Primary Purpose

Schizophrenia

Status
Completed
Phase
Phase 3
Locations
Taiwan
Study Type
Interventional
Intervention
Administration of quetiapine XR
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • The participants who were aged from 20 to 65 years and met the diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) were eligible for the recruitment to the clinical trial.
  • They also 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.

Exclusion Criteria:

  • Any DSM-IV-TR Axis I disorder other than schizophrenia, except comorbid obsessive-compulsive disorder, anxiety disorder, eating disorders or impulse control disorders if they had been stable and had not been primary focus of treatment over the previous 6 months
  • An imminent risk of suicide or a danger to self or others
  • Pregnancy or lactation
  • Intolerance or lack of response to quetiapine IR
  • Use of cytochrome P450 3A4 inhibitors or inducers in the 14 days preceding enrolment
  • Administration of a depot antipsychotic injection within one dosing interval before recruitment
  • Unstable or inadequately treated medical illness as judged by the investigator.

Sites / Locations

  • Tri-Service General Hospital, National Defense Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Quetiapine XR

Arm Description

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.

Outcomes

Primary Outcome Measures

Efficacy Assessments
The variable of the primary endpoint was the change from baseline to Week 12 in PANSS total and subscale score.

Secondary Outcome Measures

Safety Assessments
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.

Full Information

First Posted
May 12, 2014
Last Updated
May 15, 2014
Sponsor
Tri-Service General Hospital
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT02142556
Brief Title
The Efficacy and Safety of Quetiapine XR in Patients With Schizophrenia Switched From Other Antipsychotics
Official Title
The Efficacy and Safety of Once-daily Quetiapine Extended Release in Patients With Schizophrenia Switched From Other Antipsychotics
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
March 2012 (Actual)
Study Completion Date
March 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital
Collaborators
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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. Methods: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Quetiapine XR
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Administration of quetiapine XR
Intervention Description
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.
Primary Outcome Measure Information:
Title
Efficacy Assessments
Description
The variable of the primary endpoint was the change from baseline to Week 12 in PANSS total and subscale score.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Safety Assessments
Description
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.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Other Safety Assessments-the measure is a composite for metabolic disturbance
Description
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.
Time Frame
12 weeks
Title
Another efficacy assessment-CGI-S
Description
Another efficacy endpoint was the difference from baseline to the end of study in Clinical Global Impression-Severity (CGI-S) score in the participants.
Time Frame
12 weeks
Title
other safety assessments-the measure is a composite for EPS
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The participants who were aged from 20 to 65 years and met the diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision (DSM-IV-TR) were eligible for the recruitment to the clinical trial. They also 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. Exclusion Criteria: Any DSM-IV-TR Axis I disorder other than schizophrenia, except comorbid obsessive-compulsive disorder, anxiety disorder, eating disorders or impulse control disorders if they had been stable and had not been primary focus of treatment over the previous 6 months An imminent risk of suicide or a danger to self or others Pregnancy or lactation Intolerance or lack of response to quetiapine IR Use of cytochrome P450 3A4 inhibitors or inducers in the 14 days preceding enrolment Administration of a depot antipsychotic injection within one dosing interval before recruitment Unstable or inadequately treated medical illness as judged by the investigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chin-Bin Yeh, M.D., Ph.D.
Organizational Affiliation
Tri-Service General Hospital, National Defense Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tri-Service General Hospital, National Defense Medical Center
City
Taipei
ZIP/Postal Code
114
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25609320
Citation
Pan PY, Lee MS, Yeh CB. 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. BMC Psychiatry. 2015 Jan 22;15:1. doi: 10.1186/s12888-014-0378-5.
Results Reference
derived

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The Efficacy and Safety of Quetiapine XR in Patients With Schizophrenia Switched From Other Antipsychotics

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