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Seroquel XR in Adults With Schizophrenia

This study has been terminated.
(The study was prematurely terminated due to insufficient recruitment.)
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00852631
First received: February 26, 2009
Last updated: June 12, 2012
Last verified: May 2012
History of Changes
  Purpose

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 Intervention Phase
Schizophrenia
 Drug: Quetiapine fumarate (Seroquel)
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Change in Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: From Day 1 (baseline) to Day 42 ] [ Designated as safety issue: Yes ]

    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:
  • Change in Clinical Global Impression - Severity of Illness (CGI-S) Score [ Time Frame: From Day 1 (Baseline) to Day 42 ] [ Designated as safety issue: Yes ]
    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.

  • Clinical Global Impression - Severity of Illness (CGI-S) Score [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 28
Study Start Date: February 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Quetiapine fumarate (Seroquel)
    600mg Extended release tablet, oral, once daily
    Other Name: Seroquel XR
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00852631

Locations
Thailand
Research Site
Bangkok, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Songkla, Thailand
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Thawatchai Leelahanaj, MD Phramongkutklao Hospital, Bangkok, Thailand
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00852631     History of Changes
Other Study ID Numbers: D1443L00060
Study First Received: February 26, 2009
Results First Received: May 18, 2011
Last Updated: June 12, 2012
Health Authority: Thailand: Ethical Committee

Keywords provided by AstraZeneca:
Quetiapine efficacy in schizophrenia

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
 Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on May 23, 2013