Clinical trial NCT00119652: Seroquel in Bipolar Depression Versus SSRI
Official title: Multicentre, Double-blind, Randomised, Parallel Group, Placebo Controlled, Phase 3 Study of the Efficacy & Safety of Quetiapine Fumarate & Paroxetine 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: 2005-07-14
Enrollment: 676
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: The purpose of this study is to determine whether quetiapine is effective and safe in the acute treatment of bipolar depression and whether the effect is maintained when treatment is continued.


Eligibility criteria: Inclusion Criteria:

* Male and female out-patients aged 18 to 65 years inclusive
* Diagnosis of Bipolar Disorder (Bipolar I or Bipolar II), most recent episode depressed

Exclusion Criteria:

* Current period of depression lasting less than 4 weeks or more than 12 months
* Use of prohibited medication
* Substance or alcohol dependence or abuse
* Current suicide risk or suicide attempt within 6 months
* Breast feeding or pregnancy
* Clinically relevant disease or clinical finding

Primary outcomes:
measure: Change from baseline to Week 8 assessment in the total score on the Montgomery-Asberg Depression Rating Scale (MADRS)
Secondary outcomes:
measure: Secondary variables supportive to the primary objective:
measure: MADRS total score response
measure: MADRS total score remission
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Research Site
state: Arizona
city: Little Rock
country: United States
facility: Research Site
state: Arkansas
city: National City
country: United States
facility: Research Site
state: California
city: San Clemente
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Maitland
country: United States
facility: Research Site
state: Florida
city: Winter Park
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Smyrna
country: United States
facility: Research Site
state: Georgia
city: Northfield
country: United States
facility: Research Site
state: Illinois
city: Oak Brook
country: United States
facility: Research Site
state: Illinois
city: New Orleans
country: United States
facility: Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Glen Burnie
country: United States
facility: Research Site
state: Maryland
city: St. Louis
country: United States
facility: Research Site
state: Missouri
city: Clementon
country: United States
facility: Research Site
state: New Jersey
city: New York
country: United States
facility: Research Site
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Research Site
state: Ohio
city: Dayton
country: United States
facility: Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Research Site
state: Oklahoma
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Austin
country: United States
facility: Research Site
state: Texas
city: Dallas
country: United States
facility: Research Site
state: Texas
city: Irving
country: United States
facility: Research Site
state: Texas
city: Richmond
country: United States
facility: Research Site
state: Virginia
city: Bellevue
country: United States
facility: Research Site
state: Washington
city: Kirkland
country: United States
facility: Research Site
state: Washington
city: Brisbane
country: Australia
facility: Research Site
state: Queensland
city: Everton Park
country: Australia
facility: Research Site
state: Queensland
city: Southport
country: Australia
facility: Research Site
state: Queensland
city: Epping
country: Australia
facility: Research Site
state: Victoria
city: Malvern
country: Australia
facility: Research Site
state: Victoria
city: Providencia Santiago
country: Chile
facility: Research Site
city: Santiago
country: Chile
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: San Jose
country: Costa Rica
facility: Research Site
city: Athens
country: Greece
facility: Research Site
city: Thessaloniki
country: Greece
facility: Research Site
city: Tripoli
country: Greece
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: Yucatan
country: Mexico
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: San Borja
country: Peru
facility: Research Site
city: Bucharest
country: Romania
facility: Research Site
city: Galati
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Magura
country: Romania
facility: Research Site
city: Benoni
country: South Africa
facility: Research Site
city: Cape Town
country: South Africa
facility: Research Site
city: Durban
country: South Africa
facility: Research Site
city: Pretoria
country: South Africa
facility: Research Site
city: Gaziantep
country: Turkey
facility: Research Site
city: Istanbul
country: Turkey
facility: Research Site
city: Manisa
country: Turkey
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: AstraZeneca Seroquel Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: McElroy SL, Weisler RH, Chang W, Olausson B, Paulsson B, Brecher M, Agambaram V, Merideth C, Nordenhem A, Young AH; EMBOLDEN II (Trial D1447C00134) Investigators. A double-blind, placebo-controlled study of quetiapine and paroxetine as monotherapy in adults with bipolar depression (EMBOLDEN II). J Clin Psychiatry. 2010 Feb;71(2):163-74. doi: 10.4088/JCP.08m04942gre. Epub 2010 Jan 26.