Acute Bipolar ManiaPhase 4STARNCT01254721
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
A Phase 4 study testing Quetiapine fumarate and lithium in people with Acute Bipolar Mania, run by AstraZeneca at 5 sites in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Bipolar Mania
- What is being tested?
- Quetiapine fumarate and lithium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 5 sitesSouth Korea
- Study dates
- Dec 2010to Oct 2012
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
South Korea5 sites
Research Site
Ansan, Gyeonggi-do
Research Site
Daegu, Gyeongsangbuk-do
Research Site
Jinju, Gyeongsangnam-do
Research Site
Pusan, Gyeongsangnam-do
Research Site
Seoul, Seoul
About this study
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
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.
Read the 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.
- Conditions
- Acute Bipolar Mania
- Being tested
- Quetiapine fumarate, lithium
- Keywords
- Acute bipolar mania, Seroquel XR, Seroquel XR plus lithium, Quetiapine fumarate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quetiapine fumarateDrug
eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study.
lithiumDrug
300mg tablet, oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Seroquel XR tablet Receives: Drug: Quetiapine fumarate |
| 2 | Active comparator | Seroquel XR + lithium Receives: Drug: Quetiapine fumarate; Drug: lithium |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score 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.
Measured: From Baseline to Day 29
Secondary outcomes (1)
The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)
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".
Measured: From Baseline to Day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2010 (estimated)
- Study startDec 2010
- Primary completionOct 2012
- Study completionOct 2012
Why it stopped: Difficulty of recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Bipolar 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yeon Ho Joo, Principal investigator, Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01254721
- Sponsor's protocol ID
- D1443L00086
- Acronym
- STAR
- Status last verified
- Apr 2014
- First submitted
- 3 Dec 2010
- Last updated
- 8 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01254721
- Acronym / sponsor ID
- STAR / D1443L00086
- Conditions
- Acute Bipolar Mania
- Keywords
- Acute bipolar mania, Seroquel XR, Seroquel XR plus lithium, Quetiapine fumarate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulty of recruitment.
- Enrolment
- 131 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 7 Dec 2010 (estimated)
- Results
- Posted 8 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Quetiapine fumarateSeroquel XR tablet |
| 2 | Active comparator | Drug: Quetiapine fumarate, Drug: lithiumSeroquel XR + lithium |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 fumarateeXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study. | Drug | 1, 2 |
| lithium300mg tablet, oral | Drug | 2 |
Primary outcome
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.
1 secondary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Acute Bipolar Mania
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Risperidone vs Cariprazine in Acute Mania
Bipolar 1 Disorder
RecruitingObservational study
Immune Mechanisms of Antipsychotic Treatment Response
Psychosis
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.
Yeon Ho Joo principal investigator
Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Quetiapine fumarate and lithium in people with Acute Bipolar Mania, run by AstraZeneca at 5 sites in South Korea.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 8 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in South Korea. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29 (time frame: From Baseline to Day 29). 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 8 May 2014.