Study Stopped
study was not ethically acceptable to continue and therefore it was finally stopped
FAST-A Study to Evaluate the Efficacy and Safety of Quetiapin IR in Patients With Acute Psychosis
FAST
2 other identifiers
interventional
N/A
1 country
13
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2007
Shorter than P25 for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedFirst Submitted
Initial submission to the registry
June 14, 2007
CompletedFirst Posted
Study publicly available on registry
June 15, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedDecember 10, 2010
April 1, 2009
3 months
June 14, 2007
December 8, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of Positive and Negative Syndrome Scale-Excitatory Subscale (PANSS-EC) at day 5 compared with baseline at day 1
Secondary Outcomes (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
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (13)
Research Site
Borås, Sweden
Research Site
Danderyd, Sweden
Research Site
Falköping, Sweden
Research Site
Gothenburg, Sweden
Research Site
Karlskrona, Sweden
Research Site
Malmo, Sweden
Research Site
Öjebyn, Sweden
Research Site
Piteå, Sweden
Research Site
Simrishamn, Sweden
Research Site
Stockholm, Sweden
Research Site
Trollhättan, Sweden
Research Site
Vaxjo, Sweden
Research Site
Västerås, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jaan Ruusa, MD,PhD
Huddinge Hospital Stockholm Sweden
- STUDY DIRECTOR
Birgit Ekholm, MD
AstraZeneca Sweden AB
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
June 14, 2007
First Posted
June 15, 2007
Study Start
May 1, 2007
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
December 10, 2010
Record last verified: 2009-04