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

This study has been terminated.
(study was not ethically acceptable to continue and therefore it was finally stopped)
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00486798
First received: June 14, 2007
Last updated: December 8, 2010
Last verified: April 2009
  Purpose

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

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

Study Start Date: May 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00486798     History of Changes
Other Study ID Numbers: D1443L00009, EUDRAC No. 2006-006426-26
Study First Received: June 14, 2007
Last Updated: December 8, 2010
Health Authority: Sweden: Medical Products Agency

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

Additional relevant MeSH terms:
Bipolar Disorder
Psychotic Disorders
Mental Disorders
Schizophrenia
Affective Disorders, Psychotic
Mood Disorders
Schizophrenia and Disorders with Psychotic Features
Quetiapine
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 20, 2014