Back to resultsFAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis (FAST)
Primary Purpose
Psychotic Disorders, Schizophrenia, Bipolar Disorder
Status
Terminated
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Quetiapine
Rating Scales
Self Assessment Form
Blood and urine samples
Sleeping pattern
Sponsored by
About this trial
This is an interventional treatment trial for Psychotic Disorders focused on measuring acute schizophrenia, schizoaffective disorder, psychosis Not Otherwise Specified (NOS), bipolar mania with psychotic symptoms
Eligibility 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
Sites / Locations
- Research Site
- Research Site
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- Research Site
Outcomes
Primary Outcome Measures
Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00486798
Brief Title
FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis
Acronym
FAST
Study Type
Interventional
2. Study Status
Record Verification Date
April 2009
Overall Recruitment Status
Terminated
Why Stopped
study was not ethically acceptable to continue and therefore it was finally stopped
Study Start Date
May 2007 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychotic Disorders, Schizophrenia, Bipolar Disorder
Keywords
acute schizophrenia, schizoaffective disorder, psychosis Not Otherwise Specified (NOS), bipolar mania with psychotic symptoms
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine
Intervention Type
Procedure
Intervention Name(s)
Rating Scales
Intervention Type
Procedure
Intervention Name(s)
Self Assessment Form
Intervention Type
Procedure
Intervention Name(s)
Blood and urine samples
Intervention Type
Procedure
Intervention Name(s)
Sleeping pattern
Primary Outcome Measure Information:
Title
Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaan Ruusa, MD,PhD
Organizational Affiliation
Huddinge Hospital Stockholm Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Birgit Ekholm, MD
Organizational Affiliation
AstraZeneca Sweden AB
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Boras
Country
Sweden
Facility Name
Research Site
City
Danderyd
Country
Sweden
Facility Name
Research Site
City
Falkoping
Country
Sweden
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Karlskrona
Country
Sweden
Facility Name
Research Site
City
Malmo
Country
Sweden
Facility Name
Research Site
City
Ojebyn
Country
Sweden
Facility Name
Research Site
City
Pitea
Country
Sweden
Facility Name
Research Site
City
Simrishamn
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Trollhattan
Country
Sweden
Facility Name
Research Site
City
Vasteras
Country
Sweden
Facility Name
Research Site
City
Vaxjo
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis
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