Clinical trial NCT02142556: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
Collaborators: name: AstraZeneca
First posted: 2014-05-20
Enrollment: 61
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Efficacy Assessments
timeFrame: 12 weeks
Secondary outcomes:
measure: Safety Assessments
timeFrame: 12 weeks
Other outcomes:
measure: Other Safety Assessments-the measure is a composite for metabolic disturbance
timeFrame: 12 weeks
measure: Another efficacy assessment-CGI-S
timeFrame: 12 weeks
measure: other safety assessments-the measure is a composite for EPS
timeFrame: 12 weeks
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital, National Defense Medical Center
Study officials:
affiliation: Tri-Service General Hospital, National Defense Medical Center
name: Chin-Bin Yeh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.