Seroquel in Bipolar Depression Versus Lithium

Depression Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00206141
• Other study ID #: D1447C00001
• Secondary ID: EMBOLDEN I
• Status: Completed
• Phase: Phase 3
• First received: September 13, 2005
• Last updated: January 3, 2013
• Start date: August 2005
• Est. completion date: May 2007

Study information

• Verified date: January 2013
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 672
• Est. completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bipolar Depression
• Bipolar Disorder
• Depression
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Canada	Research Site	Kelowna	British Columbia
Canada	Research Site	Markham	Ontario
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Orleans	Ontario
Canada	Research Site	Sherbrooke	Quebec
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Sydney	Nova Scotia
Canada	Research Site	Waterloo	Ontario
Croatia	Research Site	Osijek
Croatia	Research Site	Split
Croatia	Research Site	Zadar
Croatia	Research Site	Zagreb-Susedgrad
Estonia	Research Site	Kohtla-Jarve
Estonia	Research Site	Tallinn
Estonia	Research Site	Tartu
Germany	Research Site	Berlin
Germany	Research Site	Würzburg
Indonesia	Research Site	Jakarta
Indonesia	Research Site	Lawang
Indonesia	Research Site	Solo	Java
Korea, Republic of	Research Site	Gyeonggi-do
Korea, Republic of	Research Site	Seoul
Latvia	Research Site	Daugavpils
Latvia	Research Site	Riga
Lithuania	Research Site	Kaunas
Lithuania	Research Site	Siauliai
Lithuania	Research Site	Vilnius
Malaysia	Research Site	Kuala Lumpur
Malaysia	Research Site	Kuching Sarawak
Malaysia	Research Site	Petaling Jaya
Norway	Research Site	Brattvag
Norway	Research Site	Drammen
Norway	Research Site	Fredrikstad
Norway	Research Site	Mysen
Norway	Research Site	Paradis
Philippines	Research Site	Davao
Philippines	Research Site	Iloilo
Philippines	Research Site	Mandaluyong City
Philippines	Research Site	Manila
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdynia
Poland	Research Site	Leszno
Poland	Research Site	Lodz
Poland	Research Site	Skorzewo
Poland	Research Site	Wroclaw
Poland	Research Site	Zabrze
Russian Federation	Research Site	Arkhangelsk
Russian Federation	Research Site	Kazan
Russian Federation	Research Site	Lipetsk
Russian Federation	Research Site	Moscow
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	St. Petersburg
Russian Federation	Research Site	Stavropol
Russian Federation	Research Site	Tver
Russian Federation	Research Site	Yaroslavl
Serbia	Research Site	Belgrade
Serbia	Research Site	Cacak
Serbia	Research Site	Kragujevac
Serbia	Research Site	Niš
Serbia	Research Site	Valjevo
Taiwan	Research Site	Changhua
Taiwan	Research Site	Taipei
Ukraine	Research Site	Dnipropetrovsk
Ukraine	Research Site	Donetsk
Ukraine	Research Site	Kharkiv
Ukraine	Research Site	Kiev
Ukraine	Research Site	Lugansk
Ukraine	Research Site	Lviv
Ukraine	Research Site	Odessa
Ukraine	Research Site	Simferopol
Ukraine	Research Site	Vinnitsa

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Canada,  Croatia,  Estonia,  Germany,  Indonesia,  Korea, Republic of,  Latvia,  Lithuania,  Malaysia,  Norway,  Philippines,  Poland,  Russian Federation,  Serbia,  Taiwan,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Secondary	MADRS total score response
Secondary	MADRS total score remission