Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
356 participants
INTERVENTIONAL
2009-06-30
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Seroquel XR and Lithium
Quetiapine fumarate XR
Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator.
Lithium
Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator.
2
Seroquel XR and placebo
Quetiapine fumarate XR
Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator.
Placebo
Oral treatment twice daily.
Interventions
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Quetiapine fumarate XR
Oral treatment, once daily, Day 1 = 300 mg, Day 2 and thereafter 600 mg. Dose might be adjusted as from Day 3 by the discretion of the investigator.
Lithium
Oral treatment, twice daily, Days 1 and 2 = 600 mg/day, Days 3-8 = 900 mg/day. Dose adjustment from day 9 to end of study will be at the discretion of the investigator.
Placebo
Oral treatment twice daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* The patient must have a documented clinical diagnosis for bipolar I disorder, including recent episode manic or mixed, and being male of females age 18-65 years, inclusive.
* Patients may be outpatients or inpatients at enrollment visit, but all patients must be inpatients when randomized and remain inpatients until discharged at the discretion of the investigator.
Exclusion Criteria
* The patient can not have a past diagnosis of stroke or medically documented transient ischemic attacks (TIA) or a history of seizure disorder, except for febrile convulsions.
* The patient must not have received electroconvulsive treatment (ECT) within 90 days before participating in the study and in the doctors judgement pose a current suicidal or homicidal risk.
18 Years
65 Years
ALL
No
Sponsors
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Quintiles, Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Michael Castiglione
Role: STUDY_DIRECTOR
AstraZeneca
Michel Bourin, Professeur
Role: PRINCIPAL_INVESTIGATOR
Neurobiologie de l'anxiété et de la dépression Faculté de Médecine
Locations
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Research Site
Montignies-sur-Sambre, Belgium, Belgium
Research Site
Overpelt, Belgium, Belgium
Research Site
Cedex, Cedex, Belgium
Research Site
Dendermonde, , Belgium
Research Site
Tournai, , Belgium
Research Site
Burgas, Bulgaria, Bulgaria
Research Site
Radnevo, Bulgaria, Bulgaria
Research Site
Cedex, Cedex, Bulgaria
Research Site
Kazanlak, , Bulgaria
Research Site
Pazardzhik, , Bulgaria
Research Site
Plovdiv, , Bulgaria
Research Site
Sofia, , Bulgaria
Research Site
Cedex, Cedex, Germany
Research Site
Cologne, North Rhine-Westphalia, Germany
Research Site
Berlin, State of Berlin, Germany
Research Site
Berlin, , Germany
Research Site
Mannheim, , Germany
Research Site
München, , Germany
Research Site
Nuremberg, , Germany
Research Site
Visakhapatnam, Andh Prad, India
Research Site
Cedex, Cedex, India
Research Site
Ahmedabad, Gujarat, India
Research Site
Bangalore, Karna, India
Research Site
Mangalore, Karna, India
Research Site
Manipal, Karna, India
Research Site
Nashik, Mahara, India
Research Site
Jaipur, Rajasthan, India
Research Site
Kanpur, Uttar Prad, India
Research Site
Cedex, Cedex, Israel
Research Site
Bat Yam, , Israel
Research Site
Beer Ya'acov, , Israel
Research Site
Haifa, , Israel
Research Site
Petah Tikva, , Israel
Research Site
Tel Litwinsky, , Israel
Research Site
Cedex, Cedex, Poland
Research Site
Bydgoszcz, Poland, Poland
Research Site
Choroszcz, Poland, Poland
Research Site
Gorlice, , Poland
Research Site
Katowice, , Poland
Research Site
Krakow, , Poland
Research Site
Lublin, , Poland
Research Site
Poznan, , Poland
Research Site
Cedex, Cedex, Russia
Research Site
Arkhangelsk, , Russia
Research Site
Chita, , Russia
Research Site
Kazan', , Russia
Research Site
Moscow, , Russia
Research Site
Saint Petersburg, , Russia
Research Site
Saratov, , Russia
Research Site
Voronezh, , Russia
Research Site
Cedex, Cedex, South Africa
Research Site
Bloemfontein, Free State, South Africa
Research Site
Vereeniging, Free State, South Africa
Research Site
Worcester, W Cape, South Africa
Research Site
Cape Town, , South Africa
Research Site
Johannesburg, , South Africa
Research Site
Port Elizabeth, , South Africa
Research Site
Cedex, Cedex, Ukraine
Research Site
Kharkiv, Ukraine, Ukraine
Research Site
Kiev, Ukraine, Ukraine
Research Site
Dnipropetrovsk, , Ukraine
Research Site
Donetsk, , Ukraine
Research Site
Kiev, , Ukraine
Research Site
Odesa, , Ukraine
Research Site
Vinnitsia, , Ukraine
Countries
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References
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Bourin MS, Severus E, Schronen JP, Gass P, Szamosi J, Eriksson H, Chandrashekar H. Lithium as add-on to quetiapine XR in adult patients with acute mania: a 6-week, multicenter, double-blind, randomized, placebo-controlled study. Int J Bipolar Disord. 2014 Nov 8;2:14. doi: 10.1186/s40345-014-0014-9. eCollection 2014.
Other Identifiers
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D144AC00003
Identifier Type: -
Identifier Source: org_study_id
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