Clinical trial NCT00206141: Seroquel in Bipolar Depression Versus Lithium
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Bipolar Depression
Depression
Keywords: Bipolar disorder
bipolar depression
depression
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2005-09-21
Enrollment: 672
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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

Primary outcomes:
measure: The change from randomization to Week 8 assessment in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Secondary outcomes:
measure: MADRS total score response
measure: MADRS total score remission
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: Research Site
state: British Columbia
city: Sydney
country: Canada
facility: Research Site
state: Nova Scotia
city: Markham
country: Canada
facility: Research Site
state: Ontario
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Orleans
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Waterloo
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Sherbrooke
country: Canada
facility: Research Site
state: Quebec
city: Osijek
country: Croatia
facility: Research Site
city: Split
country: Croatia
facility: Research Site
city: Zadar
country: Croatia
facility: Research Site
city: Zagreb-Susedgrad
country: Croatia
facility: Research Site
city: Kohtla-Jarve
country: Estonia
facility: Research Site
city: Tallinn
country: Estonia
facility: Research Site
city: Tartu
country: Estonia
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Würzburg
country: Germany
facility: Research Site
city: Solo
country: Indonesia
facility: Research Site
state: Java
city: Jakarta
country: Indonesia
facility: Research Site
city: Lawang
country: Indonesia
facility: Research Site
city: Gyeonggi-do
country: Korea, Republic of
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Daugavpils
country: Latvia
facility: Research Site
city: Riga
country: Latvia
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Siauliai
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Kuching Sarawak
country: Malaysia
facility: Research Site
city: Petaling Jaya
country: Malaysia
facility: Research Site
city: Brattvag
country: Norway
facility: Research Site
city: Drammen
country: Norway
facility: Research Site
city: Fredrikstad
country: Norway
facility: Research Site
city: Mysen
country: Norway
facility: Research Site
city: Paradis
country: Norway
facility: Research Site
city: Davao
country: Philippines
facility: Research Site
city: Iloilo
country: Philippines
facility: Research Site
city: Mandaluyong City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdynia
country: Poland
facility: Research Site
city: Leszno
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Skorzewo
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
city: Zabrze
country: Poland
facility: Research Site
city: Arkhangelsk
country: Russian Federation
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Lipetsk
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Research Site
city: Rostov-on-Don
country: Russian Federation
facility: Research Site
city: Saratov
country: Russian Federation
facility: Research Site
city: Smolensk
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Stavropol
country: Russian Federation
facility: Research Site
city: Tver
country: Russian Federation
facility: Research Site
city: Yaroslavl
country: Russian Federation
facility: Research Site
city: Belgrade
country: Serbia
facility: Research Site
city: Cacak
country: Serbia
facility: Research Site
city: Kragujevac
country: Serbia
facility: Research Site
city: Niš
country: Serbia
facility: Research Site
city: Valjevo
country: Serbia
facility: Research Site
city: Changhua
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Lugansk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Odessa
country: Ukraine
facility: Research Site
city: Simferopol
country: Ukraine
facility: Research Site
city: Vinnitsa
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Seroquel Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Young AH, McElroy SL, Bauer M, Philips N, Chang W, Olausson B, Paulsson B, Brecher M; EMBOLDEN I (Trial 001) Investigators. A double-blind, placebo-controlled study of quetiapine and lithium monotherapy in adults in the acute phase of bipolar depression (EMBOLDEN I). J Clin Psychiatry. 2010 Feb;71(2):150-62. doi: 10.4088/JCP.08m04995gre. Epub 2010 Jan 26.