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Study terminated due to poor recruitment
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The purpose of this study is to determine whether increasing the amount (dose) of quetiapine IR (immediate release formulation) more rapidly than conventional dose increases, improves the control of symptoms as measured by the Positive and Negative Syndrome Scale (PANSS) - a psychiatric assessment scale that measures both positive and negative symptoms - in patients with acute schizophrenia or schizoaffective disorder.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine IR (Immediate Release) | Drug | oral |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome variable of this study is change from baseline in total PANSS score | at Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in total PANSS scores | on day 5 and 14 | |
| change from baseline in CGI-S and absolute CGI-I | on days 5, 7 and 14 | |
| frequency and severity of adverse events; change in vital signs. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| AstraZeneca UK Medical Director, MD | AstraZeneca UK | Study Director |
| Professor Gary Sullivan, MD | St Tydfil's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Brentwood | Essex | United Kingdom | |||
| Research Site |
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| assessed at each visit |
| change from baseline in subscale PANSS and PANSS-EC scores | on days 5, 7 and 14 |
| Harrow |
| Middlesex |
| United Kingdom |
| Research Site | Surbiton | Surrey | United Kingdom |
| Research Site | Birmingham | United Kingdom |
| Research Site | Bognor Regis | United Kingdom |
| Research Site | Bury St Edmunds | United Kingdom |
| Research Site | Coventry | United Kingdom |
| Research Site | Crewe | United Kingdom |
| Research Site | Darlington | United Kingdom |
| Research Site | London | United Kingdom |
| Research Site | Sandbach | United Kingdom |
| Research Site | Warrington | United Kingdom |
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| 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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