Seroquel XR in Adults With Schizophrenia

Study Overview
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Brief Summary
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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.

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

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Quetiapine fumarate (Seroquel)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Quetiapine fumarate (Seroquel)|600mg Extended release tablet, oral, once daily|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Quetiapine efficacy in schizophrenia