Adult Bipolar Mania

PHASE4CompletedINTERVENTIONAL
Enrollment

356

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

November 30, 2010

Study Completion Date

November 30, 2010

Conditions
Acute Mania
Interventions
DRUG

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.

DRUG

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.

DRUG

Placebo

Oral treatment twice daily.

Trial Locations (65)

Unknown

Research Site, Montignies-sur-Sambre

Research Site, Overpelt

Research Site, Cedex

Research Site, Dendermonde

Research Site, Tournai

Research Site, Burgas

Research Site, Radnevo

Research Site, Cedex

Research Site, Kazanlak

Research Site, Pazardzhik

Research Site, Plovdiv

Research Site, Sofia

Research Site, Cedex

Research Site, Cologne

Research Site, Berlin

Research Site, Berlin

Research Site, Mannheim

Research Site, München

Research Site, Nuremberg

Research Site, Visakhapatnam

Research Site, Cedex

Research Site, Ahmedabad

Research Site, Bangalore

Research Site, Mangalore

Research Site, Manipal

Research Site, Nashik

Research Site, Jaipur

Research Site, Kanpur

Research Site, Cedex

Research Site, Bat Yam

Research Site, Beer Ya'acov

Research Site, Haifa

Research Site, Petah Tikva

Research Site, Tel Litwinsky

Research Site, Cedex

Research Site, Bydgoszcz

Research Site, Choroszcz

Research Site, Gorlice

Research Site, Katowice

Research Site, Krakow

Research Site, Lublin

Research Site, Poznan

Research Site, Cedex

Research Site, Arkhangelsk

Research Site, Chita

Research Site, Kazan'

Research Site, Moscow

Research Site, Saint Petersburg

Research Site, Saratov

Research Site, Voronezh

Research Site, Cedex

Research Site, Bloemfontein

Research Site, Vereeniging

Research Site, Worcester

Research Site, Cape Town

Research Site, Johannesburg

Research Site, Port Elizabeth

Research Site, Cedex

Research Site, Kharkiv

Research Site, Kiev

Research Site, Dnipropetrovsk

Research Site, Donetsk

Research Site, Kiev

Research Site, Odesa

Research Site, Vinnitsia

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Quintiles, Inc.

INDUSTRY

lead

AstraZeneca

INDUSTRY