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

NCT ID: NCT00486798

Last Updated: 2010-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2007-05-31

Study Completion Date

2007-08-31

Brief Summary

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The purpose of this study is to compare the efficacy of quetiapine IR, following rapid titration versus conventional titration in patients with acute psychosis

Detailed Description

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Conditions

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Psychotic Disorders Schizophrenia Bipolar Disorder

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Quetiapine

Intervention Type DRUG

Rating Scales

Intervention Type PROCEDURE

Self Assessment Form

Intervention Type PROCEDURE

Blood and urine samples

Intervention Type PROCEDURE

Sleeping pattern

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Principal Investigators

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Jaan Ruusa, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Huddinge Hospital Stockholm Sweden

Birgit Ekholm, MD

Role: STUDY_DIRECTOR

AstraZeneca Sweden AB

Locations

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Research Site

Borås, , Sweden

Site Status

Research Site

Danderyd, , Sweden

Site Status

Research Site

Falköping, , Sweden

Site Status

Research Site

Gothenburg, , Sweden

Site Status

Research Site

Karlskrona, , Sweden

Site Status

Research Site

Malmo, , Sweden

Site Status

Research Site

Öjebyn, , Sweden

Site Status

Research Site

Piteå, , Sweden

Site Status

Research Site

Simrishamn, , Sweden

Site Status

Research Site

Stockholm, , Sweden

Site Status

Research Site

Trollhättan, , Sweden

Site Status

Research Site

Vaxjo, , Sweden

Site Status

Research Site

Västerås, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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EUDRAC No. 2006-006426-26

Identifier Type: -

Identifier Source: secondary_id

D1443L00009

Identifier Type: -

Identifier Source: org_study_id