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Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients (STAR)
This study has been completed.

First Received on March 16, 2007.   Last Updated on December 7, 2010   History of Changes
Sponsor: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00448578
  Purpose

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.


Condition Intervention Phase
Mania
Bipolar Disorder
Drug: Quetiapine Fumarate
Drug: Lithium
Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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).

Estimated Enrollment: 150
Study Start Date: August 2005
Study Completion Date: June 2006
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00448578

Locations
China
Research Sites
Beijing, China
Research Site
Guang Zhou, China
Research Site
Kunming, China
Research Site
Nanjing, China
Research Site
Shanghai, China
Research Site
Wu han, China
Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Clara Gu AstraZeneca
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00448578     History of Changes
Other Study ID Numbers: D1440L00006
Study First Received: March 16, 2007
Last Updated: December 7, 2010
Health Authority: China: State Food and Drug Administration

Keywords provided by AstraZeneca:
Acute Mania

Additional relevant MeSH terms:
Bipolar Disorder
Affective Disorders, Psychotic
Mood Disorders
Mental Disorders
Lithium
Quetiapine
Lithium Carbonate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Antimanic Agents
Antidepressive Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012