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Seroquel XR in Adults With Schizophrenia

NCT ID: NCT00852631

Last Updated: 2012-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2010-05-31

Brief Summary

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The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.

Detailed Description

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Conditions

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Schizophrenia

Keywords

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Quetiapine efficacy in schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Quetiapine fumarate (Seroquel)

600mg Extended release tablet, oral, once daily

Intervention Type DRUG

Other Intervention Names

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Seroquel XR

Eligibility Criteria

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Inclusion Criteria

* Patient meets the DSM-IV criteria for schizophrenia
* Patient has a PANSS total score ≥ 70 at baseline
* Patient has a CGI-S score of ≥ 4(moderately ill) at baseline
* Patient is healthy on the basis of physical examination and vital signs at baseline

Exclusion Criteria

* Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse
* Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B or C virus antigen
* Patient with unstable or inadequately treated Diabetes Mellitus
* Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thawatchai Leelahanaj, MD

Role: PRINCIPAL_INVESTIGATOR

Phramongkutklao Hospital, Bangkok, Thailand

Locations

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Research Site

Bangkok, , Thailand

Site Status

Research Site

Chiang Mai, , Thailand

Site Status

Research Site

Songkhla, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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D1443L00060

Identifier Type: -

Identifier Source: org_study_id