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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

February 26, 2009
June 12, 2012
February 2009
May 2010   (final data collection date for primary outcome measure)
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%.
  • Change in PANSS total score from baseline (day 1) to final visit (day 42) [ Time Frame: At screening, day 1, day 14 and day 42 ] [ Designated as safety issue: No ]
  • Recording of adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00852631 on ClinicalTrials.gov Archive Site
  • 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.
  • Change in PANSS total score from baseline to each post-baseline visit [ Time Frame: At screening, day 1, day 14 and day 42 ] [ Designated as safety issue: No ]
  • Change in CGI assessment [ Time Frame: At screening, day 1, day 14 and day 42 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Seroquel XR in Adults With Schizophrenia
Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia

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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Schizophrenia
Drug: Quetiapine fumarate (Seroquel)
600mg Extended release tablet, oral, once daily
Other Name: Seroquel XR
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
28
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Thailand
 
NCT00852631
D1443L00060
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Thawatchai Leelahanaj, MD Phramongkutklao Hospital, Bangkok, Thailand
AstraZeneca
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP