Seroquel in Bipolar Depression Versus Lithium

Condition(s) targeted: Bipolar Disorder; Bipolar Depression; Depression

Intervention: Quetiapine Fumarate (Seroquel™) drug, mood stabilizer (mood) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZeneca

This study is being carried out to see if quetiapine fumarate (Seroquel) is effective in treating bipolar depression during an 8-week acute phase compared with placebo and lithium, followed by continuation treatment for 26 up to 52 with quetiapine fumarate (Seroquel) compared to placebo.

Official title: Multi-Centre, Double-Blind, Randomised, Parallel-Group, Placebo-Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Lithium as Monotherapy in Adult Patients With Bipolar Depression for 8 Weeks & Quetiapine in Continuation (Abbreviated)

Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.

Secondary outcome:

MADRS total score response

MADRS total score remission

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Patients with a diagnosis of bipolar I disorder or bipolar II disorder, currently

depressed, aged 18 to 65 years old and outpatient status at enrolment and randomization.

Exclusion Criteria:

- Patients with a current DSM-IV Axis I disorder other than bipolar disorder that is

symptomatic or requiring treatment within 6 months of enrolment,

- History of non-response to an adequate treatment

- Patients who, in the investigator’s judgment pose a current serious suicidal or

homicidal risk

- Pregnancy or lactation

- Clinically relevant disease or clinical finding

Research Site, Zagreb-Susedgrad, Croatia

Research Site, Osijek, Croatia

Research Site, Split, Croatia

Research Site, Zadar, Croatia

Research Site, Kohtla-Jarve, Estonia

Research Site, Tartu, Estonia

Research Site, Tallinn, Estonia

Research Site, Berlin, Germany

Research Site, Würzburg, Germany

Research Site, Lawang, Indonesia

Research Site, Jakarta, Indonesia

Research Site, Seoul, Korea, Republic of

Research Site, Gyeonggi-do, Korea, Republic of

Research Site, Riga, Latvia

Research Site, Daugavpils, Latvia

Research Site, Vilnius, Lithuania

Research Site, Kaunas, Lithuania

Research Site, Siauliai, Lithuania

Research Site, Kuala Lumpur, Malaysia

Research Site, Petaling Jaya, Malaysia

Research Site, Kuching Sarawak, Malaysia

Research Site, Mysen, Norway

Research Site, Paradis, Norway

Research Site, Brattvag, Norway

Research Site, Drammen, Norway

Research Site, Fredrikstad, Norway

Research Site, Mandaluyong City, Philippines

Research Site, Iloilo, Philippines

Research Site, Davao, Philippines

Research Site, Manila, Philippines

Research Site, Bialystok, Poland

Research Site, Gdynia, Poland

Research Site, Leszno, Poland

Research Site, Lodz, Poland

Research Site, Skorzewo, Poland

Research Site, Wroclaw, Poland

Research Site, Zabrze, Poland

Research Site, BYDGOSZCZ, Poland

Research Site, Moscow, Russian Federation

Research Site, St. Petersburg, Russian Federation

Research Site, Kazan, Russian Federation

Research Site, Lipetsk, Russian Federation

Research Site, Nizhniy Novgorod, Russian Federation

Research Site, Rostov-on-Don, Russian Federation

Research Site, Saratov, Russian Federation

Research Site, Smolensk, Russian Federation

Research Site, Stavropol, Russian Federation

Research Site, Tver, Russian Federation

Research Site, Yaroslavl, Russian Federation

Research Site, ARKHANGELSK, Russian Federation

Research Site, Belgrade, Serbia and Montenegro

Research Site, Kragujevac, Serbia and Montenegro

Research Site, Niš, Serbia and Montenegro

Research Site, Valjevo, Serbia and Montenegro

Research Site, Cacak, Serbia and Montenegro

Research Site, Taipei, Taiwan

Research Site, Changhua, Taiwan

Research Site, Lviv, Ukraine

Research Site, Kharkiv, Ukraine

Research Site, Odessa, Ukraine

Research Site, Kiev, Ukraine

Research Site, Simferopol, Ukraine

Research Site, Vinnitsa, Ukraine

Research Site, Dnipropetrovsk, Ukraine

Research Site, Donetsk, Ukraine

Research Site, Lugansk, Ukraine

Research Site, Kelowna, British Columbia, Canada

Research Site, Solo, Java, Indonesia

Research Site, Sydney, Nova Scotia, Canada

Research Site, Markham, Ontario, Canada

Research Site, Mississauga, Ontario, Canada

Research Site, Orleans, Ontario, Canada

Research Site, Sudbury, Ontario, Canada

Research Site, Waterloo, Ontario, Canada

Research Site, Montreal, Quebec, Canada

Research Site, Sherbrooke, Quebec, Canada

Starting date: August 2005
Last updated: July 17, 2007