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Quetiapine Fumarate Bipolar Maintenance Monotherapy (SPaRCLe)

Primary Purpose

Bipolar Disorder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
quetiapine fumarate
Sponsored by
AstraZeneca
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar I disorder.

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent 18 years or older A diagnosis of Bipolar I Disorder Have a current manic, depressed or mixed episode Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine Female patients of childbearing potential must be using a reliable method of contraception Exclusion Criteria: Pregnancy Substance or alcohol dependence at enrollment Unstable thyroid function Unstable Diabetes Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension Use of an experimental drug within 30 days of enrollment

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Outcomes

Primary Outcome Measures

Time from randomization to recurrence of a mood event

Secondary Outcome Measures

Time from randomization to recurrence of a manic event
Time from randomization to recurrence of a depressed event

Full Information

First Posted
April 11, 2006
Last Updated
December 19, 2008
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00314184
Brief Title
Quetiapine Fumarate Bipolar Maintenance Monotherapy
Acronym
SPaRCLe
Official Title
Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients
Study Type
Interventional

2. Study Status

Record Verification Date
December 2008
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. Study Description

Brief Summary
This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder. PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar I disorder.

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1255 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
quetiapine fumarate
Other Intervention Name(s)
Seroquel
Primary Outcome Measure Information:
Title
Time from randomization to recurrence of a mood event
Secondary Outcome Measure Information:
Title
Time from randomization to recurrence of a manic event
Title
Time from randomization to recurrence of a depressed event

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent 18 years or older A diagnosis of Bipolar I Disorder Have a current manic, depressed or mixed episode Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine Female patients of childbearing potential must be using a reliable method of contraception Exclusion Criteria: Pregnancy Substance or alcohol dependence at enrollment Unstable thyroid function Unstable Diabetes Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension Use of an experimental drug within 30 days of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca CNS Medical Science Director, MD
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Cerritos
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California
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United States
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San Diego
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California
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United States
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Santa Ana
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California
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United States
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Washington
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District of Columbia
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United States
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Gainesville
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Florida
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United States
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Jacksonville
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Florida
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United States
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North Miami
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Florida
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United States
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Orlando
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Florida
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United States
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Atlanta
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Georgia
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United States
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Eagle
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Idaho
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United States
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Hoffman Estates
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Illinois
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United States
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Terre Haute
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Indiana
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United States
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Shreveport
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Louisiana
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United States
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Flowood
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Mississippi
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United States
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St. Charles
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Missouri
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United States
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Las Vegas
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Nevada
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United States
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Clementon
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New Jersey
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United States
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Rochester
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New York
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United States
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Raleigh
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North Carolina
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United States
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Fargo
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North Dakota
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United States
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Portland
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Oregon
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United States
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Salem
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United States
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Philadelphia
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United States
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Memphis
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United States
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Austin
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United States
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Lake Jackson
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Texas
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United States
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Richmond
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Virginia
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United States
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Bellevue
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United States
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Kirkland
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Washington
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United States
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Seattle
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Washington
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United States
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Capital Federal
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Argentina
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Cordoba
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Argentina
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La Plata
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Argentina
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Lanus
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Argentina
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Mendoza
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Argentina
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Rosario
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Argentina
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Bourgas
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Bulgaria
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Plovdiv
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Bulgaria
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Sofia
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Bulgaria
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Antioquia
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Colombia
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Barranquilla
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Colombia
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Bogota
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Colombia
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Pereira
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Colombia
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Ahmedabad
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India
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Chennai
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India
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Jaipur
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India
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Kanpur
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India
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Lucknow
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India
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Mangalore
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India
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Manipal
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India
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Mumbai
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India
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New Delhi
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India
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Visakhapatnam
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India
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Kaunas
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Lithuania
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Klaipeda
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Lithuania
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Vilnius
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Lithuania
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Kuala Lumpur
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Malaysia
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Sarawak
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Malaysia
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Leon
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Mexico
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Mexico
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Mexico
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San Luis Potosi
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Mexico
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Lima
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Peru
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Cebu City
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Philippines
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Davao City
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Philippines
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Mandaluyong City
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Philippines
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Manila
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Philippines
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Quezon City
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Philippines
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Arad
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Romania
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Brasov
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Romania
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Bucuresti
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Romania
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Cluj-Napoca
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Romania
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Com Jebel
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Romania
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Craiova
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Romania
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Iasi
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Romania
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Oradea
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Romania
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Pitesti
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Romania
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Sibiu
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Romania
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Targoviste
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Romania
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Targu Mures
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Romania
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Kazan
Country
Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Russian Federation
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Kaohsiung Hsien
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Taiwan
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Taipei
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Taiwan
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Taoyuan City
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Taiwan
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Taoyuan Hsien
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Taiwan
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Bangkok
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Thailand
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Dnepropetrovsk
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Ukraine
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Kharkiv
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Ukraine
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Kiev
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Ukraine
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Kyiv
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Ukraine
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Lviv
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Ukraine
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Odessa
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Ukraine
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Simferopol
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Ukraine
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Vinnitsa
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
22054050
Citation
Weisler RH, Nolen WA, Neijber A, Hellqvist A, Paulsson B; Trial 144 Study Investigators. Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study). J Clin Psychiatry. 2011 Nov;72(11):1452-64. doi: 10.4088/JCP.11m06878. Erratum In: J Clin Psychiatry. 2014 Mar;75(3):290.
Results Reference
derived

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Quetiapine Fumarate Bipolar Maintenance Monotherapy

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