- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00448578
Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients (STAR)
December 7, 2010 updated by: AstraZeneca
A Double Dummy & Double Blind, Multicenter, Randomized Study of the Efficacy and Safety of Seroquel (Quetiapine Fumarate) and Lithium as Monotherapy in the Treatment of Acute Mania in Patients With Bipolar Disorder
This is a randomised, double blind, double dummy, multicentre, parallel-group study to compare the efficacy and safety of quetiapine and lithium used as monotherapy in the treatment of mania in patients hospitalised for an acute manic episode.
After given of informed consent and undergoing screening procedures, the patients will be randomised into quetiapine or lithium group on Day 1.
The efficacy of study treatment on symptoms of mania will be assessed at Day 28.
Patients will not permitted to use any psychoactive or antipsychotic medications throughout the study period other than those expressly permitted by the protocol.
The patients are required to be hospitalised for the treatment and assessment defined in the protocol.
He/She could be discharged from the hospital after Week 2 (i.e.
On Day 15) if the investigator believes that it will be clinical appropriate to discharge the patient, that the patient is not suicidal or homicidal, and that the patient could reasonably be expected to continue in the study on an outpatient basis.
The patients discharged after Day 15 will be given sufficient study medication for the period from discharge to the next visit.
At each centre, the same individual will administer a specific psychiatric assessment for a patient at all study visits in order to reduce variability in rating scale scoring.
Before the initiation of the study, a consistency assessment will be done among the investigators who conduct the scale assessment in each centre.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
150
Phase
- Phase 3
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
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Beijing, China
- Research Sites
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Guang Zhou, China
- Research Site
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Kunming, China
- Research Site
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Nanjing, China
- Research Site
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Shanghai, China
- Research Site
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Wu han, China
- Research Site
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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:
- Written informed consent for study participation, signed by the patient's legal guardian.
- Both at screening and at randomization (Day 1), had a YMRS total score of at least 20.
Exclusion Criteria:
- Known intolerance or lack of response to quetiapine or lithium, as judged by the investigator.
- Known or suspected hypersensitivity to quetiapine 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 Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Effectiveness of quetiapine fumarate used as monotherapy in treatment of symptoms of acute mania in patients with bipolar disorder by evaluation of the change from baseline in YMRS total score at Day 28 using the last observation carried forward method
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Secondary Outcome Measures
Outcome Measure |
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The effectiveness of quetiapine used as monotherapy to treat symptoms in patients with acute mania by evaluation of YMRS response rate at Day 28 (LOCF).
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Clara Gu, AstraZeneca
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
August 1, 2005
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
March 16, 2007
First Submitted That Met QC Criteria
March 16, 2007
First Posted (Estimate)
March 19, 2007
Study Record Updates
Last Update Posted (Estimate)
December 9, 2010
Last Update Submitted That Met QC Criteria
December 7, 2010
Last Verified
December 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Bipolar and Related Disorders
- Bipolar Disorder
- Mania
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Antidepressive Agents
- Quetiapine Fumarate
Other Study ID Numbers
- D1440L00006
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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