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The purpose of this 6-week study is to determine whether treatment with Seroquel® Sustained Release (SR) is more effective than placebo in the treatment of acute schizophrenia.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Seroquel Sustained Release (SR) | Drug | |||
| Seroquel Immediate Release (IR) | Drug | |||
| Placebo | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome variable will be the change from baseline of the Positive and Negative Syndrome Scale (PANSS) total score at the end of treatment at Day 42. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy | ||
| To demonstrate a higher PANSS response rate | ||
| To demonstrate superior Clinical Global Impressions (CGI) response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca CNS Medical Science Director, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Burgas | Bulgaria | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17592906 | Derived | Kahn RS, Schulz SC, Palazov VD, Reyes EB, Brecher M, Svensson O, Andersson HM, Meulien D; Study 132 Investigators. Efficacy and tolerability of once-daily extended release quetiapine fumarate in acute schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychiatry. 2007 Jun;68(6):832-42. doi: 10.4088/jcp.v68n0603. |
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| Rousse |
| Bulgaria |
| Research Site | Sofia | Bulgaria |
| Research Site | Sofia- Novi Iskar | Bulgaria |
| Research Site | Athens | Greece |
| Research Site | Chania | Greece |
| Research Site | Corfu | Greece |
| Research Site | Thessaloniki | Greece |
| Research Site | Chennai | India |
| Research Site | Karnataka | India |
| Research Site | Lucknow | India |
| Research Site | New Delhi | India |
| Research Site | Jakarta | DKI Jakarta | Indonesia |
| Research Site | Bandung | West Java | Indonesia |
| Research Site | Surabaya | Indonesia |
| Research Site | Cebu | Philippines |
| Research Site | Davao City | Philippines |
| Research Site | Mandaluyong | Philippines |
| Research Site | Manila | Philippines |
| Research Site | Pasig | Philippines |
| Research Site | Brasov | Romania |
| Research Site | Bucharest | Romania |
| Research Site | Moscow | Russia |
| Research Site | Saint Petersburg | Russia |
| Research Site | Johannesburg | Gauteng | South Africa |
| Research Site | Medunsa | Pretoria | South Africa |
| Research Site | Bloemfontein | South Africa |
| Research Site | Ga-Rankuwa | South Africa |
| Research Site | Johannesburg | South Africa |
| Research Site | Lyttelton Manor | South Africa |
| Research Site | Pretoria | South Africa |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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