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Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients

NCT ID: NCT00448578

Last Updated: 2010-12-09

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

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-08-31

Study Completion Date

2006-06-30

Brief Summary

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This is a randomised, double blind, double dummy, multicentre, parallel-group study to compare the efficacy and safety of quetiapine and lithium used as monotherapy in the treatment of mania in patients hospitalised for an acute manic episode. After given of informed consent and undergoing screening procedures, the patients will be randomised into quetiapine or lithium group on Day 1. The efficacy of study treatment on symptoms of mania will be assessed at Day 28. Patients will not permitted to use any psychoactive or antipsychotic medications throughout the study period other than those expressly permitted by the protocol. The patients are required to be hospitalised for the treatment and assessment defined in the protocol. He/She could be discharged from the hospital after Week 2 (i.e. On Day 15) if the investigator believes that it will be clinical appropriate to discharge the patient, that the patient is not suicidal or homicidal, and that the patient could reasonably be expected to continue in the study on an outpatient basis. The patients discharged after Day 15 will be given sufficient study medication for the period from discharge to the next visit. At each centre, the same individual will administer a specific psychiatric assessment for a patient at all study visits in order to reduce variability in rating scale scoring. Before the initiation of the study, a consistency assessment will be done among the investigators who conduct the scale assessment in each centre.

Detailed Description

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Conditions

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Mania Bipolar Disorder

Keywords

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Acute Mania

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Quetiapine Fumarate

Intervention Type DRUG

Lithium

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent for study participation, signed by the patient's legal guardian.
* Both at screening and at randomization (Day 1), had a YMRS total score of at least 20.

Exclusion Criteria

* Known intolerance or lack of response to quetiapine or lithium, as judged by the investigator.
* Known or suspected hypersensitivity to quetiapine or lithium.
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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Clara Gu

Role: STUDY_CHAIR

AstraZeneca

Locations

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Research Sites

Beijing, , China

Site Status

Research Site

Guangzhou, , China

Site Status

Research Site

Kunming, , China

Site Status

Research Site

Nanjing, , China

Site Status

Research Site

Shanghai, , China

Site Status

Research Site

Wuhan, , China

Site Status

Countries

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China

Other Identifiers

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D1440L00006

Identifier Type: -

Identifier Source: org_study_id