Schizophrenia Clinical Trial
— FASTVerified date | April 2009 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | Sweden: Medical Products Agency |
Study type | Interventional |
The purpose of this study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis
Status | Terminated |
Enrollment | 0 |
Est. completion date | August 2007 |
Est. primary completion date | August 2007 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - provision of written informed consent - male or female, aged 18-65 years - requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode - able to swallow tablets from Day 1 Exclusion Criteria: - In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5 - patients with known relevant clinical disease - history of syncope, or orthostatic hypotension - patients with known neutropenia |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Research Site | Boras | |
Sweden | Research Site | Danderyd | |
Sweden | Research Site | Falkoping | |
Sweden | Research Site | Goteborg | |
Sweden | Research Site | Karlskrona | |
Sweden | Research Site | Malmo | |
Sweden | Research Site | Ojebyn | |
Sweden | Research Site | Pitea | |
Sweden | Research Site | Simrishamn | |
Sweden | Research Site | Stockholm | |
Sweden | Research Site | Trollhattan | |
Sweden | Research Site | Vasteras | |
Sweden | Research Site | Vaxjo |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1 | |||
Secondary | Assessment of PANSS-EC at Day 3 and 8. Clinical Global Impression (CGI) at baseline and at Day 5 and 8. FAST (For Acute Seroquel Therapy) rating scale at baseline and at Day 5 and 8. The sleeping pattern (8days). Withdrawals/treatment failures. AE |
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