MedTrace Logo

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

NCT01254721 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2014-05-08

Study results available
· View outcomes & findings →

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.

Conditions

  • Acute Bipolar Mania

Interventions

DRUG

Quetiapine fumarate

eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study.

DRUG

lithium

300mg tablet, oral

Sponsors & Collaborators

Principal Investigators

  • Yeon Ho Joo · Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-10-31
Completion
2012-10-31

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01254721 on ClinicalTrials.gov