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Effectiveness of Quetiapine XR on the Control of Symptoms of Manic Phase of Bipolar Disorder.

NCT ID: NCT00521365

Last Updated: 2012-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-08-31

Brief Summary

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The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.

Detailed Description

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Conditions

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Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State

Keywords

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Bipolar Disorder Bipolar Affective Psychosis Mania Manic Disorder Manic State

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quetapine 600 mg

Group Type EXPERIMENTAL

Quetiapine 600mg

Intervention Type DRUG

300 mg quetiapine fumarate tablets for oral use.

Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.

Interventions

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Quetiapine 600mg

300 mg quetiapine fumarate tablets for oral use.

Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with type I Bipolar Disorder in Manic phase according to standard scales and physician criteria.
* Patients of both genders, aged 18-65 years old being at the first episode
* Patients with chronic Bipolar Disorder with at least one previous manic episode 6 months before inclusion, that based on the physician experience are in a manic episode at study entry quality

Exclusion Criteria

* Psychoactive substance or alcohol abuse or dependence, forbidden medication, pregnancy, rapid cycling patients, intolerance to Quetiapine, clinically severe disease, unstable Diabetes Mellitus, neutropenia, other laboratory abnormalities
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

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ana Polanco, MD

Role: STUDY_DIRECTOR

AstraZeneca Mexico

Doris Gutierrez, MD

Role: PRINCIPAL_INVESTIGATOR

INP

Julieta Jimenez

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Site

Guadalajara, Jalisco, Mexico

Site Status

Research Site

Mexico City, Mexico City, Mexico

Site Status

Research Site

Monterrey, Nuevo León, Mexico

Site Status

Research Site

San Pedro Garza García, Nuevo León, Mexico

Site Status

Research Site

San Luis Potosí City, San Luis Potosí, Mexico

Site Status

Research Site

Mérida, Yucatán, Mexico

Site Status

Research Site

Durango, , Mexico

Site Status

Countries

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Mexico

Other Identifiers

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D1443L00017

Identifier Type: -

Identifier Source: org_study_id