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

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ClinicalTrials.gov Identifier: NCT00486798
Recruitment Status : Terminated (study was not ethically acceptable to continue and therefore it was finally stopped)
First Posted : June 15, 2007
Last Update Posted : December 10, 2010
Sponsor:
Information provided by:
AstraZeneca

Brief 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

Condition or disease Intervention/treatment Phase
Psychotic Disorders Schizophrenia Bipolar Disorder Drug: Quetiapine Procedure: Rating Scales Procedure: Self Assessment Form Procedure: Blood and urine samples Procedure: Sleeping pattern Phase 3

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2007
Actual Primary Completion Date : August 2007
Actual Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1

Secondary Outcome Measures :
  1. 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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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00486798


Locations
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, Sweden
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Jaan Ruusa, MD,PhD Huddinge Hospital Stockholm Sweden
Study Director: Birgit Ekholm, MD AstraZeneca Sweden AB

ClinicalTrials.gov Identifier: NCT00486798     History of Changes
Other Study ID Numbers: D1443L00009
EUDRAC No. 2006-006426-26
First Posted: June 15, 2007    Key Record Dates
Last Update Posted: December 10, 2010
Last Verified: April 2009

Keywords provided by AstraZeneca:
acute schizophrenia
schizoaffective disorder
psychosis Not Otherwise Specified (NOS)
bipolar mania with psychotic symptoms

Additional relevant MeSH terms:
Disease
Schizophrenia
Bipolar Disorder
Mental Disorders
Psychotic Disorders
Pathologic Processes
Schizophrenia Spectrum and Other Psychotic Disorders
Bipolar and Related Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs