ManiaPhase 3STARNCT00448578
Efficacy and Safety of Seroquel and Lithium as Monotherapy in Acute Mania Treatment in Bipolar Disorder Patients
A Phase 3 study testing Quetiapine Fumarate and Lithium in people with Mania and Bipolar Disorder, run by AstraZeneca at 6 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Mania, Bipolar Disorder
- What is being tested?
- Quetiapine Fumarate and Lithium
- How many people
- 150 participants
- Where
- 6 sitesChina
- Study dates
- Aug 2005to Jun 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Known intolerance or lack of response to quetiapine or lithium, as judged by the investigator.
- Known or suspected hypersensitivity to quetiapine or lithium.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites
Research Sites
Beijing
Research Site
Guangzhou
Research Site
Kunming
Research Site
Nanjing
Research Site
Shanghai
Research Site
Wuhan
About this study
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
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.
- Conditions
- Mania, Bipolar Disorder
- Being tested
- Quetiapine Fumarate, Lithium
- Keywords
- Acute Mania
- Medical subject headings
- Mania, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine FumarateDrug
LithiumDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (1)
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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2007 (estimated)
- Study startAug 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ManiaStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 150 participants
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Clara Gu, Study chair, AstraZeneca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00448578
- Sponsor's protocol ID
- D1440L00006
- Acronym
- STAR
- Status last verified
- Dec 2010
- First submitted
- 16 Mar 2007
- Last updated
- 9 Dec 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00448578
- Acronym / sponsor ID
- STAR / D1440L00006
- Conditions
- Mania, Bipolar Disorder
- Keywords
- Acute Mania
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Aug 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 19 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Known intolerance or lack of response to quetiapine or lithium, as judged by the investigator.
- Known or suspected hypersensitivity to quetiapine or lithium.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quetiapine Fumarate | Drug | – |
| Lithium | Drug | – |
Primary outcome
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
1 secondary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clara Gu study chair
AstraZeneca
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Quetiapine Fumarate and Lithium in people with Mania and Bipolar Disorder, run by AstraZeneca at 6 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2010.