Study Comparing the Tolerability of Seroquel IR With Seroquel XR in Patients With Bipolar Depression

NCT ID: NCT00926393

Last Updated: 2011-05-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2009-08-31

Brief Summary

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The purpose of the study is to compare the sedation profile one hour after dose administration between Seroquel IR and Seroquel XR.

Detailed Description

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Conditions

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Bipolar Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Quetiapine Immediate Release (IR)

Quetiapine 25, 100, 200 and 300 mg

Group Type ACTIVE_COMPARATOR

Quetiapine Immediate Release

Intervention Type DRUG

Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day

Quetiapine Extended Release (XR)

Quetiapine 50, 200, 300

Group Type ACTIVE_COMPARATOR

Quetiapine Extended Release

Intervention Type DRUG

Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day

Interventions

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Quetiapine Immediate Release

Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day

Intervention Type DRUG

Quetiapine Extended Release

Oral, 3 tablets daily: (2 x 25 mg + 1 x 50 mg) at one time each day

Intervention Type DRUG

Other Intervention Names

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Seroquel IR Seroquel XR

Eligibility Criteria

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Inclusion Criteria

* DSM-IV-TR documented bipolar I or bipolar II, most recent episode depressed
* Outpatient status as enrollment

Exclusion Criteria

* Other than bipolar disorder under study, patients must not have another current, major disorder that is symptomatic or has required treatment within 6 months of enrollment.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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AstraZeneca

Principal Investigators

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Catherine Datto, MD

Role: STUDY_DIRECTOR

AstraZeneca

References

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Riesenberg RA, Baldytcheva I, Datto C. Self-reported sedation profile of quetiapine extended-release and quetiapine immediate-release during 6-day initial dose escalation in bipolar depression: a multicenter, randomized, double-blind, phase IV study. Clin Ther. 2012 Nov;34(11):2202-11. doi: 10.1016/j.clinthera.2012.09.002. Epub 2012 Oct 8.

Reference Type DERIVED
PMID: 23059166 (View on PubMed)

Other Identifiers

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D1443C00040

Identifier Type: -

Identifier Source: org_study_id

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