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Trial record 20 of 450 for:    QUETIAPINE

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

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ClinicalTrials.gov Identifier: NCT02142556
Recruitment Status : Completed
First Posted : May 20, 2014
Last Update Posted : May 20, 2014
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Chin-Bin Yeh, Tri-Service General Hospital

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Administration of quetiapine XR Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Efficacy and Safety of Once-daily Quetiapine Extended Release in Patients With Schizophrenia Switched From Other Antipsychotics
Study Start Date : November 2008
Actual Primary Completion Date : March 2012
Actual Study Completion Date : March 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

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.




Primary Outcome Measures :
  1. Efficacy Assessments [ Time Frame: 12 weeks ]
    The variable of the primary endpoint was the change from baseline to Week 12 in PANSS total and subscale score.


Secondary Outcome Measures :
  1. Safety Assessments [ Time Frame: 12 weeks ]
    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.


Other Outcome Measures:
  1. Other Safety Assessments-the measure is a composite for metabolic disturbance [ Time Frame: 12 weeks ]
    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.

  2. Another efficacy assessment-CGI-S [ Time Frame: 12 weeks ]
    Another efficacy endpoint was the difference from baseline to the end of study in Clinical Global Impression-Severity (CGI-S) score in the participants.

  3. other safety assessments-the measure is a composite for EPS [ Time Frame: 12 weeks ]
    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.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02142556


Locations
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Taiwan
Tri-Service General Hospital, National Defense Medical Center
Taipei, Taiwan, 114
Sponsors and Collaborators
Tri-Service General Hospital
AstraZeneca
Investigators
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Principal Investigator: Chin-Bin Yeh, M.D., Ph.D. Tri-Service General Hospital, National Defense Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Chin-Bin Yeh, Chief, Associate Professor, Department of Psychiatry, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02142556     History of Changes
Other Study ID Numbers: D1443L00046
First Posted: May 20, 2014    Key Record Dates
Last Update Posted: May 20, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Antipsychotic Agents
Quetiapine Fumarate
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Antidepressive Agents