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NCT00486798 Clinical Trial

FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis

Schizophrenia Clinical Trial

— FAST  

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00486798
Other study ID # D1443L00009
Secondary ID EUDRAC No. 2006-
Status Terminated
Phase Phase 3
First received June 14, 2007
Last updated December 8, 2010
Start date May 2007
Est. completion date August 2007

Study information
Verified date April 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority Sweden: Medical Products Agency
Study type Interventional

Clinical Trial Summary

The purpose of this study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis

Recruitment information / eligibility
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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Quetiapine

Procedure:
• Rating Scales

• Self Assessment Form

• Blood and urine samples

• Sleeping pattern

Locations
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

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Sweden, 

Outcome
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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