Clinical trial NCT01254721: A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study
Official title: A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative, Phase 4 Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Acute Bipolar Mania
Keywords: Acute bipolar mania
Seroquel XR
Seroquel XR plus lithium
Quetiapine fumarate
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-12-07
Enrollment: 131
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 primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using the last observation carried forward method.

Detailed description: A comparison of the effectiveness of Seroquel XR and Seroquel XR plus lithium in patients with acute bipolar mania: An open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comparative, phase 4 study.

Eligibility criteria: Inclusion Criteria:

* Female and/or male inpatients or outpatients, aged over 18 years and under 65 years
* Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
* YMRS total score =20 at enrollment and randomization (Day 1) Patients had a history of at least one manic episode that required hospitalization and/or treatment with a mood stabilizer or antipsychotic.
* Female patients must have a negative urine human chorionic gonadotropin (HCG) test at enrolment and must be using a reliable method of birth control, ie, barrier method, oral contraceptive, implant, dermal contraception, long-term injectable contraceptive

Exclusion Criteria:

* Pregnancy or lactation Meeting the criteria for any other (than bipolar disorder) DSM-IV Axis I diagnosis, concomitant organic mental disorder or mental retardation
* Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
* Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomization/baseline
* Known intolerance or hypersensitivity to, or lack of response to previous treatment with quetiapine fumarate or lithium

Primary outcomes:
measure: The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29
timeFrame: From Baseline to Day 29
Secondary outcomes:
measure: The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)
timeFrame: From Baseline to Day 29
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Research Site
state: Gyeonggi-do
city: Daegu
country: Korea, Republic of
facility: Research Site
state: Gyeongsangbuk-do
city: Busan
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnam-do
city: Jinju
country: Korea, Republic of
facility: Research Site
state: Gyeongsangnam-do
city: Seoul
country: Korea, Republic of
facility: Research Site
Study officials:
affiliation: Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea
name: Yeon Ho Joo
role: PRINCIPAL_INVESTIGATOR
References: