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Difficulty of recruitment.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Seroquel XR tablet |
|
| 2 | Active Comparator | Seroquel XR + lithium |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine fumarate | Drug | eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From Baseline to Day 29 |
| 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) | 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". |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yeon Ho Joo | Asan Medical Center, St. Asan medical center 86, Songpa-gu, Seoul Korea | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Ansan | Gyeonggi-do | South Korea | |||
| Research Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | Seroquel XR | Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening. Treatment duration: 28 days |
| FG001 | Seroquel XR + Lithium |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| lithium | Drug | 300mg tablet, oral |
|
| From Baseline to Day 29 |
| Daegu |
| Gyeongsangbuk-do |
| South Korea |
| Research Site | Jinju | Gyeongsangnam-do | South Korea |
| Research Site | Pusan | Gyeongsangnam-do | South Korea |
| Research Site | Seoul | Seoul | South Korea |
Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L].
Treatment duration: 28 days
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Seroquel XR | Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening. Treatment duration: 28 days |
| BG001 | Seroquel XR + Lithium | Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L]. Treatment duration: 28 days |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age in ITT population. | Mean | Standard Deviation | Years |
| ||||||||||||||
| Age, Customized | Age at onset of acute bipolar mania in ITT analysis set | Mean | Standard Deviation | Years |
| ||||||||||||||
| Sex: Female, Male | Total ITT analysis set is 121 | Count of Participants | Participants |
| |||||||||||||||
| Total No. of acute bipolar mania episodes over lifetime | Mean | Standard Deviation | Episodes |
| |||||||||||||||
| Bipolar I Disorder | number of patients experiencing manic and mixed episodes in ITT analysis set | Number | Number of Patients in ITT analysis set |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Secondary | 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". | Posted | Mean | Standard Deviation | scores on the scale | From Baseline to Day 29 |
|
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| Primary | 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. | Posted | Mean | Standard Deviation | scores on the scale | From Baseline to Day 29 |
|
Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Seroquel XR | Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening. Treatment duration: 28 days | 2 | 68 | 52 | 68 | ||
| EG001 | Seroquel XR + Lithium | Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration [0.8~1.2mEq/L]. Treatment duration: 28 days | 2 | 62 | 49 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| MANIC SYMPTOMS AGGRAVATION | Psychiatric disorders | Systematic Assessment |
| ||
| BIPOLAR MANIA | Psychiatric disorders | Systematic Assessment |
| ||
| MOOD ELEVATION | Psychiatric disorders | Systematic Assessment |
| ||
| DEATH | Psychiatric disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Dyspepsia | Gastrointestinal disorders | Systematic Assessment |
| ||
| Dry mouth | Gastrointestinal disorders | Systematic Assessment |
| ||
| Nasopharyngitis | Infections and infestations | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Akathisia | Nervous system disorders | Systematic Assessment |
| ||
| Tremor | Nervous system disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Hui Jung Sin / Clinical Project Leader | SM&M Korea | 82-2-2188-2165 | ClinicalTrialTransparency@astrazeneca.com |
| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D008094 | Lithium |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D008672 | Metals, Alkali |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D019565 | Metals, Light |
| D008670 | Metals |
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| Male |
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| Mixed Episodes |
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| Units |
|---|
| Counts |
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| Participants |
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