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

The Efficacy and Safety of Once-daily Quetiapine Extended Release in Patients With Schizophrenia Switched From Other Antipsychotics

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: Administration of quetiapine XR

• Study Type: Interventional
• Enrollment (Actual): 61
• Phase: Phase 3

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 114
    • Tri-Service General Hospital, National Defense Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy Assessments	The variable of the primary endpoint was the change from baseline to Week 12 in PANSS total and subscale score.	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Other Safety Assessments-the measure is a composite for metabolic disturbance	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.	12 weeks
Another efficacy assessment-CGI-S	Another efficacy endpoint was the difference from baseline to the end of study in Clinical Global Impression-Severity (CGI-S) score in the participants.	12 weeks
other safety assessments-the measure is a composite for EPS	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.	12 weeks

Collaborators and Investigators

• Sponsor: Tri-Service General Hospital
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Chin-Bin Yeh, M.D., Ph.D., Tri-Service General Hospital, National Defense Medical Center

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2008
• Primary Completion (Actual): March 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: May 12, 2014
• First Submitted That Met QC Criteria: May 15, 2014
• First Posted (Estimate): May 20, 2014

Study Record Updates

• Last Update Posted (Estimate): May 20, 2014
• Last Update Submitted That Met QC Criteria: May 15, 2014
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Antidepressive Agents; Quetiapine Fumarate
• Other Study ID Numbers: D1443L00046