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

NCT02142556 | Completed Phase 3

• 1 other identifier: D1443L00046
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety Assessments

  12 weeks

Other Outcomes (3)

• Other Safety Assessments-the measure is a composite for metabolic disturbance

  12 weeks

• Another efficacy assessment-CGI-S

  12 weeks

• other safety assessments-the measure is a composite for EPS

  12 weeks

Study Arms (1)

Quetiapine XR

EXPERIMENTAL

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

Interventions

Administration of quetiapine XR DRUG

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.

Quetiapine XR

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Tri-Service General Hospital, National Defense Medical Center

Taipei, 114, Taiwan

Location

Related Publications (1)

• 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.

  PMID: 25609320 DERIVED

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Chin-Bin Yeh, M.D., Ph.D.

  Tri-Service General Hospital, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Associate Professor, Department of Psychiatry

Study Record Dates

• First Submitted: May 12, 2014
• First Posted: May 20, 2014
• Study Start: November 1, 2008
• Primary Completion: March 1, 2012
• Study Completion: March 1, 2012
• Last Updated: May 20, 2014

Record last verified: 2014-05

Locations

TW (1)