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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

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Bipolar Mania

Intervention: Quetiapine fumarate (Drug); lithium (Drug)

Phase: Phase 4

Status: Terminated

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
Yeon Ho Joo, Principal Investigator, Affiliation: Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29

Secondary outcome: The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)

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

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

Research Site, Seoul, Korea, Republic of

Research Site, Ansan, Gyeonggi-do, Korea, Republic of

Research Site, Daegu, Gyeongsangbuk-do, Korea, Republic of

Research Site, Busan, Gyeongsangnam-do, Korea, Republic of

Research Site, Jinju, Gyeongsangnam-do, Korea, Republic of

Additional Information

Starting date: December 2010
Last updated: April 9, 2014

Page last updated: August 23, 2015

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