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 - STAR

Study identifier:D1443L00086

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Terminated/Withdrawn

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

Medical condition

Acute bipolar mania

Phase

Phase 4

Healthy volunteers

Study drug

Quetiapine fumarate, lithium

Sex

All

Actual Enrollment

131

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Dec 2010

Primary Completion Date: 01 Oct 2012

Study Completion Date: 01 Oct 2012

Study design

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

Verification:

Verified 01 Oct 2013 by AstraZeneca

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: 1 Seroquel XR tablet	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.
Active Comparator: 2 Seroquel XR + lithium	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

Documents available

D1443L00086 Clinical Study Report Synopsis
Download
Trial Results Summaries
Available here

Contacts

Contact

Hui Jung Sin

+82-2-2188-2165

huijung.sin@astrazeneca.com

Investigators

Principal Investigator

Yeon Ho Joo

Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea