Bipolar Depression
Conditions
Keywords
Bipolar Depression, Mental disease,
Brief summary
The primary objective of this study is to evaluate the superior efficacy of quetiapine extended release(XR) mono-therapy, administered once daily compared to placebo, in the treatment of depressive symptoms in patients with Bipolar I and Bipolar II Disorder
Interventions
DRUGQuetiapine Fumarate (SEROQUEL) Extended Release
Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.
DRUGPlacebo
Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Provision of informed consent prior to any study specific procedures * Male and female patients, aged 18 to 65 years, inclusive. * Meets Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria for bipolar disorder I or bipolar II, most recent episode depressed (296.5x and 296.89x). * Hamilton Rating Scale for Depression (HAM-D) (17-item) total score of ≥ 20 and HAM-D item 1 (depressed mood) score ≥ 2 at enrolment and randomisation. * Patients must be able to understand and comply with the requirements of the study,as judged by the Investigator
Exclusion criteria
* Patients with a current Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) diagnosis other than bipolar disorder * Patients whose Young Mania Rating Scale (YMRS) total score \>12 at enrolment and randomisation. * Patients with \>8 mood episodes during the past 12 months at enrolment. * Patients whose current episode of depression exceeds 12 months or is less than 4 weeks from enrolment. * Patients with a history of non-response to an adequate treatment (6 weeks) with more than 2 classes of antidepressants during their current episode. * Alcohol or other substance dependence or abuse as defined by Diagnostic and Statistical Manual of Mental Disorders - 4th Edition (DSM-IV) criteria at enrolment that is not in extended full or extended partial remission (12 months or longer), except caffeine and nicotine dependence. * Patients who, in the Investigator's judgment, pose a current serious suicidal or homicidal risk, have a Hamilton Rating Scale for Depression (HAM-D) item 3 score ≥ 3, or have made a suicide attempt within the past 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline to Week 8 | MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) | After 8 week of start of treatment | Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12 |
| Change From Baseline to Each Assessment in MADRS Total Score | Baseline to Week 8 | MADRS total score range: 0 to 60, the higher the score, the more severe. |
| Change From Baseline to Week 8 in HAM-D Total Scores | Baseline to Week 8 | HAM-D total score range: 0 to 53, the higher the score, the more severe. Change : Total HAM-D score at week 8 minus score at baseline |
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) | 8 weeks from baseline | Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Response was defined as ≥50% reduction in MADRS total score from baseline |
| The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of Much or Very Much Improved | After 8 weeks of start of treatment | Clinical Global Impression - Bipolar - Change (CGI-BP-C) of much or Very much improved is defined as a change in CGI-BP overall bipolar illness score ≤ 2 where 1 = very much improved, 2 = much improved. |
| Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation | Baseline to Week 8 | MADRS item 10 (suicidal ideation) score range: 0 to 6, the higher the score, the more severe, Change: MADRS item 10 score at week 8 minus score at baseline |
| Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment) | After 8 weeks of start of treatment | The incidence of treatment-emergent mania is defined as ≥16 of YMRS total score on 2 consecutive assessments or at final assessment, YMRS total score range: 0-60, the higher is the total score the more severe is the disease. |
| Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | Baseline to Week 8 | CGI-BP severity of illness-Overall bipolar range = 1-7, the higher is the total score,the more severe is the disease. CGI-BP severity of illness-Depression range: 1-7, the higher is the total score, the more severe is the disease |
Countries
China
Participant flow
Recruitment details
A 56-days (8 week), multicenter, double-blind, randomized, parallel group, Phase III study was done to compare the efficacy and safety of quetiapine XR with placebo in the treatment of patients with bipolar depression. In total 296 patients were randomized in 19 centers in the China between December 2010 and November 2012.
Pre-assignment details
361 patients were enrolled in the study of which 296 patients were randomized and 65 patients were not randomized. Reasons for patients not being randomized are (22 due to eligiblity criteria not fullfilled, 40 due to subject decision, 3 due to others).
Participants by arm
| Arm | Count |
|---|---|
| Placebo Placebo matching Quetiapine XR. | 140 |
| Quetiapine XR Quetiapine Fumarate (SEROQUEL) Extended Release Tablet administered orally, once daily in the evening. | 139 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 8 | 9 |
| Overall Study | Condition under Investigation Worsened | 1 | 0 |
| Overall Study | Lack of Efficacy | 11 | 2 |
| Overall Study | Lost to Follow-up | 2 | 2 |
| Overall Study | Severe Non-Compliance to Protocol | 4 | 2 |
| Overall Study | TG=593mg/dL, not fit to participate. | 1 | 0 |
| Overall Study | Withdrawal by Subject | 23 | 22 |
Baseline characteristics
| Characteristic | Quetiapine XR | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 33.4 Years STANDARD_DEVIATION 11.9 | 32.8 Years STANDARD_DEVIATION 11 | 33.1 Years STANDARD_DEVIATION 11.4 |
| Age, Customized 18 - 39 years | 102 Participants | 105 Participants | 207 Participants |
| Age, Customized 40 - 65 years | 37 Participants | 35 Participants | 72 Participants |
| Attempted sucide No | 128 Participants | 124 Participants | 252 Participants |
| Attempted sucide Yes | 11 Participants | 16 Participants | 27 Participants |
| Bipolar Diagnosis Bipolar - I | 70 Participants | 72 Participants | 142 Participants |
| Bipolar Diagnosis Bipolar - II | 69 Participants | 68 Participants | 137 Participants |
| Duration of present depressive episode | 13.7 Weeks STANDARD_DEVIATION 10.3 | 12.3 Weeks STANDARD_DEVIATION 10 | 13 Weeks STANDARD_DEVIATION 10.1 |
| Hamilton Rating Scale for Depression (HAM-D) total score at baseline | 23.5 Scores on a scale STANDARD_DEVIATION 3.6 | 23.2 Scores on a scale STANDARD_DEVIATION 3 | 23.3 Scores on a scale STANDARD_DEVIATION 3.3 |
| MADRS total score at baseline | 28.5 Scores on a scale STANDARD_DEVIATION 5.4 | 28.8 Scores on a scale STANDARD_DEVIATION 5.3 | 28.6 Scores on a scale STANDARD_DEVIATION 5.3 |
| Race/Ethnicity, Customized Ethnicity, Chinese | 139 Participants | 140 Participants | 279 Participants |
| Race/Ethnicity, Customized Race,Asian | 139 Participants | 140 Participants | 279 Participants |
| Rapid cycling course No | 134 Participants | 132 Participants | 266 Participants |
| Rapid cycling course Yes | 5 Participants | 8 Participants | 13 Participants |
| Sex/Gender, Customized Female | 72 Participants | 73 Participants | 145 Participants |
| Sex/Gender, Customized Male | 67 Participants | 67 Participants | 134 Participants |
| Weight | 63.8 Kilogram (Kg) STANDARD_DEVIATION 13.5 | 65.2 Kilogram (Kg) STANDARD_DEVIATION 12.3 | 64.5 Kilogram (Kg) STANDARD_DEVIATION 12.9 |
| Years since Bipolar diagnosis | 2.8 Years STANDARD_DEVIATION 4.6 | 3.2 Years STANDARD_DEVIATION 4.7 | 3 Years STANDARD_DEVIATION 4.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 43 / 147 | 81 / 147 |
| serious Total, serious adverse events | 3 / 147 | 0 / 147 |
Outcome results
Primary
Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
MADRS total score range: 0 to 60, the higher the score, the more severe, Change : Total MADRS score at week 8 minus score at baseline
Time frame: Baseline to Week 8
Population: Full Analysis Set (Number of participants at Week 8: Placebo=100; Quetiapine XR=114)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Change from Baseline to End of Study | -15.27 Scores on a scale | Standard Error 0.81 |
| Placebo | Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline | 28.8 Scores on a scale | Standard Error 0.45 |
| Quetiapine XR | Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Change from Baseline to End of Study | -18.48 Scores on a scale | Standard Error 0.78 |
| Quetiapine XR | Change From Baseline (Visit 2) to End of Study (Week 8) in the Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | Baseline | 28.5 Scores on a scale | Standard Error 0.46 |
Comparison: Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)p-value: 0.00495% CI: [-5.39, -1.04]Mixed Model Repeated Measures (MMRM)
Secondary
Change From Baseline to Each Assessment in MADRS Total Score
MADRS total score range: 0 to 60, the higher the score, the more severe.
Time frame: Baseline to Week 8
Population: Full Analysis Set (Number of participants at each assessment : Baseline (Placebo=140, Quetiapine XR= 139), Week 1 (Placebo=140, Quetiapine XR= 139), Week 2 (Placebo=127, Quetiapine XR= 128), Week 4 (Placebo=114, Quetiapine XR= 120), Week 6 (Placebo=102, Quetiapine XR= 114), Week 8 (Placebo=100, Quetiapine XR= 114)).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Each Assessment in MADRS Total Score | Change from Baseline to Week 1 | -4.14 Scores on a scale | Standard Error 0.5 |
| Placebo | Change From Baseline to Each Assessment in MADRS Total Score | Change from Baseline to Week 2 | -7.70 Scores on a scale | Standard Error 0.64 |
| Placebo | Change From Baseline to Each Assessment in MADRS Total Score | Change from Baseline to Week 4 | -11.05 Scores on a scale | Standard Error 0.69 |
| Placebo | Change From Baseline to Each Assessment in MADRS Total Score | Change from Baseline to Week 6 | -13.96 Scores on a scale | Standard Error 0.76 |
| Placebo | Change From Baseline to Each Assessment in MADRS Total Score | Change from Baseline to Week 8 | -15.27 Scores on a scale | Standard Error 0.81 |
| Placebo | Change From Baseline to Each Assessment in MADRS Total Score | Baseline | 28.8 Scores on a scale | Standard Error 0.45 |
| Quetiapine XR | Change From Baseline to Each Assessment in MADRS Total Score | Change from Baseline to Week 8 | -18.48 Scores on a scale | Standard Error 0.78 |
| Quetiapine XR | Change From Baseline to Each Assessment in MADRS Total Score | Change from Baseline to Week 1 | -5.62 Scores on a scale | Standard Error 0.51 |
| Quetiapine XR | Change From Baseline to Each Assessment in MADRS Total Score | Change from Baseline to Week 6 | -16.04 Scores on a scale | Standard Error 0.74 |
| Quetiapine XR | Change From Baseline to Each Assessment in MADRS Total Score | Change from Baseline to Week 2 | -10.13 Scores on a scale | Standard Error 0.65 |
| Quetiapine XR | Change From Baseline to Each Assessment in MADRS Total Score | Baseline | 28.5 Scores on a scale | Standard Error 0.46 |
| Quetiapine XR | Change From Baseline to Each Assessment in MADRS Total Score | Change from Baseline to Week 4 | -14.18 Scores on a scale | Standard Error 0.69 |
Comparison: Change from Baseline to Week 1 in MADRS total score based on observed cases (OC)p-value: 0.02995% CI: [-2.79, -0.15]Mixed Model Repeated Measure (MMRM)
Comparison: Change from Baseline to Week 2 in MADRS total score based on observed cases (OC)p-value: 0.00695% CI: [-4.16, -0.69]Mixed Model Repeated Measure (MMRM)
Comparison: Change from Baseline to Week 4 in MADRS total score based on observed cases (OC)p-value: 0.00195% CI: [-5, -1.25]Mixed Model Repeated Measures (MMRM)
Comparison: Change from Baseline to Week 6 in MADRS total score based on observed cases (OC)p-value: 0.04595% CI: [-4.12, -0.05]Mixed Model Repeated Measures (MMRM)
Comparison: Change from Baseline to Week 8 in MADRS total score based on observed cases (OC)p-value: 0.00495% CI: [-5.39, -1.04]Mixed Model Repeated Measures (MMRM)
Secondary
Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S)
CGI-BP severity of illness-Overall bipolar range = 1-7, the higher is the total score,the more severe is the disease. CGI-BP severity of illness-Depression range: 1-7, the higher is the total score, the more severe is the disease
Time frame: Baseline to Week 8
Population: Full Anlaysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=112)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | CGI-BP-S score for Overall Bipolar (BP) Illness | -1.73 Scores on a scale | Standard Error 0.12 |
| Placebo | Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | CGI-BP-S score of depression | -1.81 Scores on a scale | Standard Error 0.13 |
| Placebo | Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | CGI-BP-S overall score Baseline | 4.5 Scores on a scale | Standard Error 0.065 |
| Placebo | Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | CGI-BP-S score for depression Baseline | 4.5 Scores on a scale | Standard Error 0.065 |
| Quetiapine XR | Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | CGI-BP-S score for depression Baseline | 4.6 Scores on a scale | Standard Error 0.068 |
| Quetiapine XR | Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | CGI-BP-S score for Overall Bipolar (BP) Illness | -2.24 Scores on a scale | Standard Error 0.12 |
| Quetiapine XR | Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | CGI-BP-S overall score Baseline | 4.6 Scores on a scale | Standard Error 0.067 |
| Quetiapine XR | Change From Baseline to Week 8 Assessment in the Clinical Global Impression Bipolar - Severity (CGI-BP-S) | CGI-BP-S score of depression | -2.28 Scores on a scale | Standard Error 0.13 |
Comparison: Change from baseline to Week 8 assessment in the CGI-BP-S score for overall Bipolar (BP) illness based on observed cases (OC)p-value: 0.00395% CI: [-0.84, -0.17]Mixed Model Repeated Measures (MMRM)
Comparison: Change from Baseline to Week 8 assessment in the CGI-BP-S score of depression based on observed cases (OC)p-value: 0.00795% CI: [-0.81, -0.13]Mixed Model Repeated Measures (MMRM)
Secondary
Change From Baseline to Week 8 in HAM-D Total Scores
HAM-D total score range: 0 to 53, the higher the score, the more severe. Change : Total HAM-D score at week 8 minus score at baseline
Time frame: Baseline to Week 8
Population: Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 8 in HAM-D Total Scores | Change from Baseline to Week 8 | -12.92 Scores on a scale | Standard Error 0.61 |
| Placebo | Change From Baseline to Week 8 in HAM-D Total Scores | Baseline | 23.2 Scores on a scale | Standard Error 1.96 |
| Quetiapine XR | Change From Baseline to Week 8 in HAM-D Total Scores | Change from Baseline to Week 8 | -15.16 Scores on a scale | Standard Error 0.59 |
| Quetiapine XR | Change From Baseline to Week 8 in HAM-D Total Scores | Baseline | 23.5 Scores on a scale | Standard Error 1.87 |
Comparison: Change from Baseline to Week 8 in HAM-D total score based on observed cases (OC)p-value: 0.00795% CI: [-3.88, -0.61]Mixed Model Repeated Measures (MMRM)
Secondary
Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation
MADRS item 10 (suicidal ideation) score range: 0 to 6, the higher the score, the more severe, Change: MADRS item 10 score at week 8 minus score at baseline
Time frame: Baseline to Week 8
Population: Full Analysis Set (Number of Participants at Week 8: Placebo=100; Quetiapine XR=114)
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation | Change from Baseline to Week 8 | -0.76 Scores on a scale | Standard Error 0.06 |
| Placebo | Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation | Baseline | 1.2 Scores on a scale | Standard Error 0.094 |
| Quetiapine XR | Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation | Change from Baseline to Week 8 | -0.98 Scores on a scale | Standard Error 0.06 |
| Quetiapine XR | Change From Baseline to Week 8 in Item 10 of Montgomery-Asberg Depression Rating Scale (MADRS) for Suicidal Ideation | Baseline | 1.0 Scores on a scale | Standard Error 0.083 |
Comparison: Change from Baseline to Week 8 in MADRS item 10 score for suicidal ideation based on observed cases (OC)p-value: 0.00595% CI: [-0.38, -0.07]Mixed Model Repeated Measures (MMRM)
Secondary
Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment)
The incidence of treatment-emergent mania is defined as ≥16 of YMRS total score on 2 consecutive assessments or at final assessment, YMRS total score range: 0-60, the higher is the total score the more severe is the disease.
Time frame: After 8 weeks of start of treatment
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment) | 4 Participants |
| Quetiapine XR | Incidence of Treatment-emergent Mania (AE of Mania or Hypomania, Defined as Young Mania Rating Scale [YMRS] Score ≥16 on 2 Consecutive Assessments or Final Assessment) | 1 Participants |
p-value: 0.23395% CI: [0.03, 2.38]Regression, Logistic
Secondary
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment)
Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Remission was defined as MADRS total score ≤12
Time frame: After 8 week of start of treatment
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) | 59 Participants |
| Quetiapine XR | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Remission (the Proportion of Subjects With a MADRS Total Score ≤ 12 at Week 8 Assessment) | 88 Participants |
p-value: 0.00195% CI: [1.46, 3.86]Regression, Logistic
Secondary
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score)
Montgomery-Asberg Depression Rating Scale (MADRS) total score range: 0 to 60, the higher the score, the more severe, Response was defined as ≥50% reduction in MADRS total score from baseline
Time frame: 8 weeks from baseline
Population: Full Analysis set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) | 62 Participants |
| Quetiapine XR | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score Response (Subjects With ≥50% Reduction From Baseline to Week 8 in MADRS Total Score) | 93 Participants |
p-value: 0.00195% CI: [1.56, 4.13]Regression, Logistic
Secondary
The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of Much or Very Much Improved
Clinical Global Impression - Bipolar - Change (CGI-BP-C) of much or Very much improved is defined as a change in CGI-BP overall bipolar illness score ≤ 2 where 1 = very much improved, 2 = much improved.
Time frame: After 8 weeks of start of treatment
Population: Full Analysis Set
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of Much or Very Much Improved | 65 Participants |
| Quetiapine XR | The Proportion of Patients at Week 8 With a Clinical Global Impression - Bipolar - Change (CGI-BP-C) of Much or Very Much Improved | 91 Participants |
p-value: 0.00495% CI: [1.26, 3.36]Regression, Logistic