Seroquel XR in Adults With Schizophrenia

Phase 3

Terminated

• Conditions: Schizophrenia

• Registration Number: NCT00852631
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-26
• Study First Submitted QC: 2009-02-26
• Study First Posted: 2009-02-27
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Results First Submitted: 2011-05-18
• Status Verified: 2012-05
• Results First Submitted QC: 2012-06-12
• Last Update Submitted: 2012-06-12
• Results First Posted: 2012-07-17
• Last Update Posted: 2012-07-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in Positive and Negative Syndrome Scale (PANSS) Total Score	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

Name	Time	Method
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score	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.
Clinical Global Impression - Severity of Illness (CGI-S) Score	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.

Trial Locations

Locations (1)

Research Site; 🇹🇭 Songkla, Thailand