Seroquel XR in Adults With Schizophrenia

Schizophrenia Clinical Trial

Official title:

Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00852631
• Other study ID #: D1443L00060
• Status: Terminated
• Phase: Phase 3
• First received: February 26, 2009
• Last updated: June 12, 2012
• Start date: February 2009
• Est. completion date: May 2010

Study information

• Verified date: May 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 28
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Quetiapine fumarate (Seroquel)
600mg Extended release tablet, oral, once daily

Locations

Country	Name	City	State
Thailand	Research Site	Bangkok
Thailand	Research Site	Chiang Mai
Thailand	Research Site	Songkla

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Positive and Negative Syndrome Scale (PANSS) Total Score	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%.	From Day 1 (baseline) to Day 42	Yes
Secondary	Change in Clinical Global Impression - Severity of Illness (CGI-S) Score	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.	From Day 1 (Baseline) to Day 42	Yes
Secondary	Clinical Global Impression - Severity of Illness (CGI-S) Score	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.	Day 14	Yes