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

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02142556
• Other study ID #: D1443L00046
• Status: Completed
• Phase: Phase 3
• First received: May 12, 2014
• Last updated: May 15, 2014
• Start date: November 2008
• Est. completion date: March 2012

Study information

• Verified date: May 2014
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan : Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: March 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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 Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital, National Defense Medical Center	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
Tri-Service General Hospital	AstraZeneca

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	No
Other	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	Yes
Primary	Efficacy Assessments	The variable of the primary endpoint was the change from baseline to Week 12 in PANSS total and subscale score.	12 weeks	No
Secondary	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	Yes