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Seroquel XR in Adults With Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00852631
Recruitment Status : Terminated (The study was prematurely terminated due to insufficient recruitment.)
First Posted : February 27, 2009
Results First Posted : July 17, 2012
Last Update Posted : July 17, 2012
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Quetiapine fumarate (Seroquel) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia
Study Start Date : February 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Intervention Details:
  • Drug: Quetiapine fumarate (Seroquel)
    600mg Extended release tablet, oral, once daily
    Other Name: Seroquel XR

Outcome Measures
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Primary Outcome Measures :
  1. Change in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: From Day 1 (baseline) to Day 42 ]

    Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210.

    Minimum value considered better is score decreased from baseline at least 30%.



Secondary Outcome Measures :
  1. Change in Clinical Global Impression - Severity of Illness (CGI-S) Score [ Time Frame: From Day 1 (Baseline) to Day 42 ]
    Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.

  2. Clinical Global Impression - Severity of Illness (CGI-S) Score [ Time Frame: Day 14 ]
    Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patient meets the DSM-IV criteria for schizophrenia
  • Patient has a PANSS total score ≥ 70 at baseline
  • Patient has a CGI-S score of ≥ 4(moderately ill) at baseline
  • Patient is healthy on the basis of physical examination and vital signs at baseline

Exclusion Criteria:

  • Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse
  • Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B or C virus antigen
  • Patient with unstable or inadequately treated Diabetes Mellitus
  • Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline
Contacts and Locations
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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): NCT00852631


Locations
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Thailand
Research Site
Bangkok, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Songkla, Thailand
Sponsors and Collaborators
AstraZeneca
Investigators
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Principal Investigator: Thawatchai Leelahanaj, MD Phramongkutklao Hospital, Bangkok, Thailand
More Information
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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00852631    
Other Study ID Numbers: D1443L00060
First Posted: February 27, 2009    Key Record Dates
Results First Posted: July 17, 2012
Last Update Posted: July 17, 2012
Last Verified: May 2012
Keywords provided by AstraZeneca:
Quetiapine efficacy in schizophrenia
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antidepressive Agents
 Psychotropic Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs