Clinical trial NCT00314184: Quetiapine Fumarate Bipolar Maintenance Monotherapy
Official title: Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled Phase 3 Study of the Efficacy and Safety of Quetiapine Fumarate and Lithium as Monotherapy for up to 104 Weeks Maintenance Treatment of Bipolar I Disorder in Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bipolar Disorder
Keywords: Bipolar I disorder.
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2006-04-13
Enrollment: 1255
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multicenter, randomized, parallel-group, double-blind, placebo-controlled study to evaluate the efficacy and safety of quetiapine and lithium (comparator in the study) for up to 104 weeks of maintenance treatment in adult patients with Bipolar I Disorder.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent
* 18 years or older
* A diagnosis of Bipolar I Disorder
* Have a current manic, depressed or mixed episode
* Have had a manic, depressed or mixed episode during the last 26 weeks that was treated with quetiapine
* Female patients of childbearing potential must be using a reliable method of contraception

Exclusion Criteria:

* Pregnancy
* Substance or alcohol dependence at enrollment
* Unstable thyroid function
* Unstable Diabetes
* Unstable or inadequately treated medical illness e.g., angina pectoris and hypertension
* Use of an experimental drug within 30 days of enrollment

Primary outcomes:
measure: Time from randomization to recurrence of a mood event
Secondary outcomes:
measure: Time from randomization to recurrence of a manic event
measure: Time from randomization to recurrence of a depressed event
Other outcomes:
Locations:
city: Cerritos
country: United States
facility: Research Site
state: California
city: San Diego
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Washington
country: United States
facility: Research Site
state: District of Columbia
city: Gainesville
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: North Miami
country: United States
facility: Research Site
state: Florida
city: Orlando
country: United States
facility: Research Site
state: Florida
city: Atlanta
country: United States
facility: Research Site
state: Georgia
city: Eagle
country: United States
facility: Research Site
state: Idaho
city: Hoffman Estates
country: United States
facility: Research Site
state: Illinois
city: Terre Haute
country: United States
facility: Research Site
state: Indiana
city: Shreveport
country: United States
facility: Research Site
state: Louisiana
city: Flowood
country: United States
facility: Research Site
state: Mississippi
city: St. Charles
country: United States
facility: Research Site
state: Missouri
city: Las Vegas
country: United States
facility: Research Site
state: Nevada
city: Clementon
country: United States
facility: Research Site
state: New Jersey
city: Rochester
country: United States
facility: Research Site
state: New York
city: Raleigh
country: United States
facility: Research Site
state: North Carolina
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: Portland
country: United States
facility: Research Site
state: Oregon
city: Salem
country: United States
facility: Research Site
state: Oregon
city: Philadelphia
country: United States
facility: Research Site
state: Pennsylvania
city: Memphis
country: United States
facility: Research Site
state: Tennessee
city: Austin
country: United States
facility: Research Site
state: Texas
city: Lake Jackson
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: Seattle
country: United States
facility: Research Site
state: Washington
city: Capital Federal
country: Argentina
facility: Research Site
city: Cordoba
country: Argentina
facility: Research Site
city: La Plata
country: Argentina
facility: Research Site
city: Lanus
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Bourgas
country: Bulgaria
facility: Research Site
city: Plovdiv
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Antioquia
country: Colombia
facility: Research Site
city: Barranquilla
country: Colombia
facility: Research Site
city: Bogota
country: Colombia
facility: Research Site
city: Pereira
country: Colombia
facility: Research Site
city: Ahmedabad
country: India
facility: Research Site
city: Chennai
country: India
facility: Research Site
city: Jaipur
country: India
facility: Research Site
city: Kanpur
country: India
facility: Research Site
city: Lucknow
country: India
facility: Research Site
city: Mangalore
country: India
facility: Research Site
city: Manipal
country: India
facility: Research Site
city: Mumbai
country: India
facility: Research Site
city: New Delhi
country: India
facility: Research Site
city: Visakhapatnam
country: India
facility: Research Site
city: Kaunas
country: Lithuania
facility: Research Site
city: Klaipeda
country: Lithuania
facility: Research Site
city: Vilnius
country: Lithuania
facility: Research Site
city: Kuala Lumpur
country: Malaysia
facility: Research Site
city: Sarawak
country: Malaysia
facility: Research Site
city: Leon
country: Mexico
facility: Research Site
city: Mexico
country: Mexico
facility: Research Site
city: San Luis Potosi
country: Mexico
facility: Research Site
city: Lima
country: Peru
facility: Research Site
city: Cebu City
country: Philippines
facility: Research Site
city: Davao City
country: Philippines
facility: Research Site
city: Mandaluyong City
country: Philippines
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Arad
country: Romania
facility: Research Site
city: Brasov
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Cluj-Napoca
country: Romania
facility: Research Site
city: Com Jebel
country: Romania
facility: Research Site
city: Craiova
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Oradea
country: Romania
facility: Research Site
city: Pitesti
country: Romania
facility: Research Site
city: Sibiu
country: Romania
facility: Research Site
city: Targoviste
country: Romania
facility: Research Site
city: Targu Mures
country: Romania
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Kaohsiung Hsien
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taoyuan City
country: Taiwan
facility: Research Site
city: Taoyuan Hsien
country: Taiwan
facility: Research Site
city: Bangkok
country: Thailand
facility: Research Site
city: Dnepropetrovsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kiev
country: Ukraine
facility: Research Site
city: Kyiv
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 CNS Medical Science Director, MD
role: STUDY_DIRECTOR
References:
citation: Weisler RH, Nolen WA, Neijber A, Hellqvist A, Paulsson B; Trial 144 Study Investigators. Continuation of quetiapine versus switching to placebo or lithium for maintenance treatment of bipolar I disorder (Trial 144: a randomized controlled study). J Clin Psychiatry. 2011 Nov;72(11):1452-64. doi: 10.4088/JCP.11m06878.