Rapid Dose Escalation of Quetiapine Versus Conventional Escalation in Acute Schizophrenic Patients

NCT ID: NCT00254787

Last Updated: 2009-06-11

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

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2006-01-31

Brief Summary

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The purpose of the study is to compare the safety and tolerability of IR (Immediate-Release) quetiapine in a rapid escalation scheme with to the current approved label titration.

Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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IR (Immediate-Release) quetiapine fumarate (drug)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Men and women age ≥18 to ≤65 years with acute schizophrenia
* Provision of written informed consent prior to enrolment

Exclusion Criteria

* Meeting the criteria for any other (than schizophrenia) psychotic disorder not in full remission, concomitant organic mental disorder or mental retardation
* Patients with substance dependence
* Female patients who are pregnant, lactating or at risk of pregnancy
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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AstraZeneca Germany Medical Director

Role: STUDY_DIRECTOR

AstraZeneca

Locations

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Research Site

Berlin, , Germany

Site Status

Research Site

Cologne, , Germany

Site Status

Research Site

Essen, , Germany

Site Status

Research Site

Hamburg, , Germany

Site Status

Research Site

Jena, , Germany

Site Status

Research Site

Werneck, , Germany

Site Status

Countries

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Germany

Other Identifiers

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RACE

Identifier Type: -

Identifier Source: secondary_id

EudraCT-No. 2004-005122-45

Identifier Type: -

Identifier Source: secondary_id

D1441L00032

Identifier Type: -

Identifier Source: org_study_id

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