Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
NCT ID: NCT00883493
Last Updated: 2012-07-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
421 participants
INTERVENTIONAL
2009-04-30
2011-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Quetiapin fumarate XR
Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapine fumarate XR
Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Quetiapin fumarate XR+Lithium carbonate
Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.
Quetiapine fumarate XR
Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Lithium carbonate
Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day
Interventions
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Quetiapine fumarate XR
Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Lithium carbonate
Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The total score of the scale that's used for the evaluation of depression (HAM-D) should be ≥20
* The total score of the scale that' used for the evaluation of mania (YMRS) should be ≤12
Exclusion Criteria
* Use of drugs that induce or inhibit the hepatic metabolizing enzymes within 14 days before randomisation
* Patients who are unable to discontinue all psychoactive medications, including antidepressants, antipsychotics, and mood stabilizers at least 7 days prior to randomisation and consistent with the pharmacokinetics of the drug
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Simavi Vahip, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Ege University Faculty of Medicine Psychiatry Department İzmir
Locations
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Research Site
La Plata, Buenos Aires, Argentina
Research Site
Godoy Cruz, Mendoza Province, Argentina
Research Site
Mendoza, Mendoza Province, Argentina
Research Site
Caba, , Argentina
Research Site
Aparecida de Goiânia, Goiás, Brazil
Research Site
Rio de Janeiro, Rio de Janeiro, Brazil
Research Site
São Paulo, São Paulo, Brazil
Research Site
Santiago, Chile, Chile
Research Site
Medellín, Antioquia, Colombia
Research Site
Bogota D.c, Cundinamarca, Colombia
Research Site
Guatemala City, Ciudad de Guatemala, Guatemala
Research Site
Monterrey, Nuevo León, Mexico
Research Site
San Luis Potosí City, San Luis Potosí, Mexico
Research Site
Durango, , Mexico
Research Site
Monterrey, , Mexico
Research Site
Lima, Lima Province, Peru
Research Site
Ankara, Turkey, Turkey (Türkiye)
Research Site
Elâzığ, Turkey, Turkey (Türkiye)
Research Site
Istanbul, Turkey, Turkey (Türkiye)
Research Site
Izmir, Turkey, Turkey (Türkiye)
Research Site
Kocaeli, Turkey, Turkey (Türkiye)
Research Site
Malatya, Turkey, Turkey (Türkiye)
Research Site
Manisa, Turkey, Turkey (Türkiye)
Research Site
Caracas, , Venezuela
Countries
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Other Identifiers
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D1443L00055
Identifier Type: -
Identifier Source: org_study_id