CClinicalTrials.gg
TerminatedNCT00486798FASTUpdated Dec 10, 2010

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

A Phase 3 interventional study of Quetiapine and Rating Scales in Psychotic Disorders, Schizophrenia and Bipolar Disorder, sponsored by AstraZeneca. Terminated at 13 sites in Sweden. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2010-12-10.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Why this study was terminated
study was not ethically acceptable to continue and therefore it was finally stopped
Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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

02

Conditions studied

  • Psychotic Disorders
  • Schizophrenia
  • Bipolar Disorder

Keywords

  • acute schizophrenia
  • schizoaffective disorder
  • psychosis Not Otherwise Specified (NOS)
  • bipolar mania with psychotic symptoms
03

In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

Browse Schizophrenia studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • DrugQuetiapine
  • ProcedureRating Scales
  • ProcedureSelf Assessment Form
  • ProcedureBlood and urine samples
  • ProcedureSleeping pattern
06

What researchers measure

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

07

Study locations

13 sites
  • 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
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00486798
Lead sponsor
AstraZeneca
First posted
Jun 15, 2007
Start date
May 2007
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Dec 10, 2010

Study contacts

Jaan Ruusa, MD,PhD
principal investigator · Huddinge Hospital Stockholm Sweden
Birgit Ekholm, MD
study director · AstraZeneca Sweden AB
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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