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The primary purpose of the study is to assess the efficacy of Quetiapine extended release 600mg per day either as monotherapy or combined therapy in the treatment of patients with mania associated to Bipolar disorder. This trial will also assess the life quality and productivity loss improvement for patients from baseline to day 21.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetapine 600 mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine 600mg | Drug | 300 mg quetiapine fumarate tablets for oral use. Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21) | Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. | Baseline and 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2. | Change in the YMRS total score from baseline to visit 2 (1 week) ,. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60. | Baseline and 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ana Polanco, MD | AstraZeneca Mexico | Study Director |
| Doris Gutierrez, MD | INP | Principal Investigator |
| Julieta Jimenez | AstraZeneca | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Guadalajara | Jalisco | Mexico | |||
| Research Site |
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Type I Bipolar Disorder in manic phase with a YMRS (Young Mania Rating Scale) score ≥12 at study entry. Patients of both genders, 18 - 65 years old, with bipolar disorder I according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria.
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine 600 mg | Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows: Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day. This study is a single arm study. All patients received quetiapine XR 600 mg. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine 600 mg | Quetiapine Extended release 600 mg per day either as monotherapy or combined therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Participants were asked for their age in years at V0 |
| 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 | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to End of Treatment (Day 21) | Change in the YMRS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF), modified intention to treat (mITT) population. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. | Modified Intention to treat patients (88). Patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 3 weeks |
|
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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 | Quetiapine 600 mg | Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows: Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day. This study is a single arm study. All patients received quetiapine XR 600 mg. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mania Increased | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Akathisia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
Open label, non comparative study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | 09645895 | 4415 | ClinicalTrialTransparency@astrazeneca.com |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D000087122 | Mania |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D019954 | Neurobehavioral Manifestations |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3 |
Change in the YMRS total score from baseline to visit 3(2 weeks). YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60. |
| Baseline and 2 weeks |
| Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF) | Number of participants that had Young Mania Rating Scale (YMRS) response at Final Visit or Last Observation Carried Forward (LOCF). A patient is scored as responder if the change from inclusion shows a reduction of 6 points in the YMRS total score. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. | 21 days ± 2 days or Last Observation Carried Forward |
| Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF). | Number of participants that had Young Mania Rating Scale (YMRS) remission at Final Visit or Last Observation Carried Forward (LOCF). A patient is classified in remission if his/her final YMRS total score was ≤11. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. | 21 days ± 2 days or Last Observation Carried Forward |
| Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I). | Clinical Global Impression-Severity(CGI-S)is a measurement of illness severity evaluated at baseline. Clinical Global Impression-Improvement(CGI-I)is a measurement of improvement taken at Final Visit (FV) or Last Observation Carried Forward(LOCF).Change CGI Total score is assessed with next equation: CGI-I total score at FV or LOCF - CGI-S score. CGI-S Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Normal 7=the most extremely ill patients. CGI-I Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Very much improved; 4= No change; 7=Very much worse. | Baseline and 3 weeks |
| Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF). | Change in the CGI- I at Final Visit or Last Observation Carried Forward (LOCF). CGI I Questionnaire has a one item with scale range 0 to 7. 0=patients who ere not assessed, 1=Very much improved; 4= No change; 7=Very much worse. | Baseline and 3 weeks |
| Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study. | Total possible index score is 0-1(0=The worsen quality of life; 1=The best Quality of life). | Baseline and 3 weeks |
| Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF). | Change from baseline to Final Visit or Last Observation Carried Forward (LOCF). Quality of Life Questionnaire (EQ5D) part 2 has 1 item with continuous scale range 0 to 100. 0=The worsen Quality of Life; 100=The best Quality of life. | Baseline and 3 weeks |
| Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF). | Change in the Simpson-Angus Scale (SAS) total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). SAS Questionnaire has a 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18. | Baseline and 3 weeks |
| Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF). | Change in the BARS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). BARS Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14. | Baseline and 3 weeks |
| Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF). | Baseline and 3 weeks |
| Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF). | Baseline and 3 weeks |
| Number of Participants With >7% Increase in Weight | Number of participants with >7% increase in weight from baseline to end of study. | Baseline and 3 weeks |
| Mexico City |
| Mexico City |
| Mexico |
| Research Site | Monterrey | Nuevo León | Mexico |
| Research Site | San Pedro Garza García | Nuevo León | Mexico |
| Research Site | San Luis Potosí City | San Luis Potosí | Mexico |
| Research Site | Mérida | Yucatán | Mexico |
| Research Site | Durango | Mexico |
| Drug compliance |
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| Usage of not allowed drugs |
|
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Participants were classified as male or female during V0. | Count of Participants | Participants |
|
| Young Mania Rating Scale (YMRS) total score | Young Mania Rating Scale (YMRS) total score at visit 1(day 0). 11 item instrument with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0 = normal; 4 or 8 = most abnormal. Total possible score is 0 - 60. | Mean | Standard Deviation | Scores on a scale |
|
| Clinical Global Impression-Severity (CGI-S) total score | Clinical Global Impression-Severity (CGI-S) total score at visit 1( day 0). 1 item instrument with scale range 0 to 7. 0 = patients who were not assessed, 1 = Normal 7 = the most extremely ill patients. | Mean | Standard Deviation | Scores on a scale |
|
| European Quality of Life 5 Dimensions (EQ5D) Questionnaire Index | European Quality of Life 5 Dimensions (EQ5D) Total possible score is 0-1 (0 = The worst quality of life; 1 = The best quality of life). | Mean | Standard Deviation | Scores on a scale |
|
| European Quality of Life 5 Dimensions (EQ5D) Questionnaire Visual Analogue Scale (VAS) | European Quality of Life 5 Dimensions (Eq5D) Visual Analog Scale (VAS) at visit 1(day 0). European Quality of Life 5 Dimensions (EQ5D) questionnaire part 2 has 1 item with continuous scale range 0 to 100, where 0= the worst quality of life and 100 = the best quality of life. | Mean | Standard Deviation | Scores on a scale |
|
| Safety scales | Simpson-Angus Scale (SAS) and Barnes Akathisia Rating Scale (BARS)total score at visit 1 (day 0). Simpson-Angus Scale (SAS) for evaluating drug-related extrapyramidal syndromes Questionnaire has 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18. Barnes Akathisia Rating Scale (BARS) Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14. | Mean | Standard Deviation | Scores on a scale |
|
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| Secondary | Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 2. | Change in the YMRS total score from baseline to visit 2 (1 week) ,. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60. | Outcome was comparing the data at baseline with the specific data at visit 2(not with the LOCF), since only 78 patients completed YMRS at visit 2 the number of patients analyzed is different respect to the LOCF (88). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 1 week |
|
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|
| Secondary | Change in the Young Mania Rating Scale (YMRS) Total Score From Baseline to Visit 3 | Change in the YMRS total score from baseline to visit 3(2 weeks). YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0-60. | Outcome was comparing the data at baseline with the specific data at visit 3 (not with the LOCF), since only 79 patients completed YMRS at visit 3 the number of patients analyzed is different respect to the LOCF (88). | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 2 weeks |
|
|
|
| Secondary | Number of Participants With Young Mania Rating Scale (YMRS) Response at Final Visit or Last Observation Carried Forward (LOCF) | Number of participants that had Young Mania Rating Scale (YMRS) response at Final Visit or Last Observation Carried Forward (LOCF). A patient is scored as responder if the change from inclusion shows a reduction of 6 points in the YMRS total score. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. | Posted | Number | Participants | 21 days ± 2 days or Last Observation Carried Forward |
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|
|
| Secondary | Number of Participants With Young Mania Rating Scale (YMRS) Remission at Final Visit or Last Observation Carried Forward (LOCF). | Number of participants that had Young Mania Rating Scale (YMRS) remission at Final Visit or Last Observation Carried Forward (LOCF). A patient is classified in remission if his/her final YMRS total score was ≤11. YMRS questionnaire has 11 items with scale range 0 to 4 for 7 items and 0 to 8 for 4 items. 0=normal; 4 or 8=most abnormal. Total possible score is 0 - 60. | Posted | Number | Participants | 21 days ± 2 days or Last Observation Carried Forward |
|
|
|
| Secondary | Change in the Clinical Global Impression (CGI) Total Score From Baseline (CGI-S) to Final Visit or Last Observation Carried Forward (LOCF)(CGI-I). | Clinical Global Impression-Severity(CGI-S)is a measurement of illness severity evaluated at baseline. Clinical Global Impression-Improvement(CGI-I)is a measurement of improvement taken at Final Visit (FV) or Last Observation Carried Forward(LOCF).Change CGI Total score is assessed with next equation: CGI-I total score at FV or LOCF - CGI-S score. CGI-S Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Normal 7=the most extremely ill patients. CGI-I Questionnaire has a scale range 0-7. 0=patients who are not assessed, 1=Very much improved; 4= No change; 7=Very much worse. | Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 3 weeks |
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| Secondary | Change in the Clinical Global Impression - Improvement (CGI-I) at Final Visit or Last Observation Carried Forward (LOCF). | Change in the CGI- I at Final Visit or Last Observation Carried Forward (LOCF). CGI I Questionnaire has a one item with scale range 0 to 7. 0=patients who ere not assessed, 1=Very much improved; 4= No change; 7=Very much worse. | Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 3 weeks |
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| Secondary | Change in the Quality of Life Questionnaire EQ5D Index From Baseline to End of the Study. | Total possible index score is 0-1(0=The worsen quality of life; 1=The best Quality of life). | Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 3 weeks |
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| Secondary | Change in the Quality of Life Questionnaire EQ5D Visual Analogue Scale (VAS) From Baseline to Final Visit or Last Observation Carried Forward (LOCF). | Change from baseline to Final Visit or Last Observation Carried Forward (LOCF). Quality of Life Questionnaire (EQ5D) part 2 has 1 item with continuous scale range 0 to 100. 0=The worsen Quality of Life; 100=The best Quality of life. | Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 3 weeks |
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| Secondary | Change in the Simpson-Angus Scale (SAS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF). | Change in the Simpson-Angus Scale (SAS) total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). SAS Questionnaire has a 6 items with scale range 0 to 3 for each item.0=Normal; 3=Most abnormal. Total possible score is 0-18. | Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 3 weeks |
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| Secondary | Change in the Barnes Akathisia Rating Scale (BARS) Total Score From Baseline to Final Visit or Last Observation Carried Forward (LOCF). | Change in the BARS total score from baseline to Final Visit or Last Observation Carried Forward (LOCF). BARS Questionnaire has 4 items with scale range 0 to 3 for 3 items and 0 to 5 for 1 item. 0=Normal; 3 or 5=Most abnormal. Total possible score is 0-14. | Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and 3 weeks |
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| Secondary | Change in Weight From Baseline to Final Visit or Last Observation Carried Forward (LOCF). | Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline. | Posted | Mean | Standard Deviation | Kg | Baseline and 3 weeks |
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| Secondary | Change in Waist Circumference From Baseline to Final Visit or Last Observation Carried Forward (LOCF). | Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline. | Posted | Mean | Standard Deviation | cm | Baseline and 3 weeks |
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| Secondary | Number of Participants With >7% Increase in Weight | Number of participants with >7% increase in weight from baseline to end of study. | Modified Intention to treat patients mITT- (88), for each outcome measure where mITT is evaluated, population is the group of patients who had taken at least one dose of study drug and had at least one evaluable Young Mania Rating Scale at baseline. | Posted | Number | Participants | Baseline and 3 weeks |
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|
|
| 1 |
| 88 |
| 30 |
| 88 |
| Cephalea | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Hypertriglycerides | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Tachycardia | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
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| Tremor | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Anxiety | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |