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Seroquel XR in Adults With Schizophrenia

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Quetiapine fumarate (Seroquel) (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Thawatchai Leelahanaj, MD, Principal Investigator, Affiliation: Phramongkutklao Hospital, Bangkok, Thailand

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.

Clinical Details

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

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

Primary outcome: Change in Positive and Negative Syndrome Scale (PANSS) Total Score

Secondary outcome:

Change in Clinical Global Impression - Severity of Illness (CGI-S) Score

Clinical Global Impression - Severity of Illness (CGI-S) Score

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Research Site, Bangkok, Thailand

Research Site, Chiang Mai, Thailand

Research Site, Songkla, Thailand

Additional Information

Starting date: February 2009
Last updated: June 12, 2012

Page last updated: August 23, 2015

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