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)

April 9, 2014 updated by: AstraZeneca

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

131

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Research Site
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of
        • Research Site
    • Gyeongsangbuk-do
      • Daegu, Gyeongsangbuk-do, Korea, Republic of
        • Research Site
    • Gyeongsangnam-do
      • Busan, Gyeongsangnam-do, Korea, Republic of
        • Research Site
      • Jinju, Gyeongsangnam-do, Korea, Republic of
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29
Time Frame: From Baseline to Day 29
The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.
From Baseline to Day 29

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)
Time Frame: From Baseline to Day 29
The Severity of Illness scale (CGI-S) is scored to rate the patient's current clinical state. The score range is form 0 to 7. A CGI-S score of 1 indicates that a patient is "Normal, not at all ill" and a score of 7 indicates that a patient is "Among the most extremely ill patients".
From Baseline to Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2010

Primary Completion (ACTUAL)

October 1, 2012

Study Completion (ACTUAL)

October 1, 2012

Study Registration Dates

First Submitted

December 3, 2010

First Submitted That Met QC Criteria

December 6, 2010

First Posted (ESTIMATE)

December 7, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

May 8, 2014

Last Update Submitted That Met QC Criteria

April 9, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D1443L00086

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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