Bipolar Depression, Bipolar Disorder
Conditions
Keywords
Bipolar disorder, Bipolar depression, quetiapine, sertraline
Brief summary
Prospective, open-label, controlled (active comparator), randomized study of 8 weeks follow-up for the evaluation of the efficacy of extended release quetiapine (quetiapine XR) versus Sertraline in addition to previous mood stabilizer treatment (lithium or valproate at stable and clinically therapeutic blood levels) in the treatment of the adult bipolar depression. This multicentric study will be featured in two sites in Spain.
Interventions
DRUGExtended release quetiapine (quetiapine XR)
Flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. Quetiapine XR was initiated at 50 mg/day and titrated to 100 mg on day 2, 200 mg on day 3, 300 mg on day 4, and flexible doses of 300 to 600 mg/d from day 5 to the end of the study.
DRUGSertraline
Flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length. Sertraline titration: 50 mg on day 1-3, 100 mg on day 4, and flexible doses of 50 to 200 mg/d from day 5 to the end of the study.
DRUGadequate mood stabilizer
An adequate mood stabilizer treatment with lithium or valproate(defined as a serum concentration of 0.5-1.2 mEq/L or 50-100 microg/ml, respectively).
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult ambulatory patients diagnosed of bipolar disorder I or II, current depressive episode (DSM-IV-TR 4ª Ed: 296.5x or 296.89 codes) * Have been treated with only one mood stabilizer (lithium or valproate) in optimal and stable doses during at least the previous 4 weeks to randomization * Hamilton Depression Rating Scale (HDRS-17) total score ≥ 20 and Young Mania Rating Scale (YMRS) total score ≤ 14 at the screening and randomization visits - Informed consent signed
Exclusion criteria
* Patients with any axis I or II Diagnostic and Statistical Manual of Mental Disorders, 4th edition, text revision (DSM-IV-TR) diagnoses different from bipolar disorder I or II - Length of current depressive episode less than 2 weeks or more than 12 months * Having been treated with more than one mood stabilizer or any mood stabilizer other than Lithium or valproate, any antidepressant, any antipsychotic or any CP450-3A inductor/inhibitor within the 7 days period prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | baseline, week 2 | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | baseline, week 1 | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) |
| The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | baseline, week 4 | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) |
| The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | baseline. week 8 | MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms) |
| The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | baseline, week 1 | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) |
| The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | baseline, week 2 | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) |
| The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | baseline, week 4 | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity) |
| The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | baseline, week 8 | CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity) |
| The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score | baseline, week 4 | HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) |
| The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score | baseline, week 8 | HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms) |
| Number of Patients With Response at Week 2 | week 2 | Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. |
| Number of Patients With Response at Week 4. | week 4 | Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. |
| Number of Patients With Response at Week 8. | week 8 | Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. |
| Number of Patients With Remission at Week 1. | week 1 | Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. |
| Number of Patients With Remission at Week 2. | week 2 | Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. |
| Number of Patients With Remission at Week 4. | week 4 | Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. |
| Number of Patients With Remission at Week 8. | week 8 | Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. |
| Number of Patients Response at Week 1 | week 1 | Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms. |
Countries
Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Quetiapine Extended Release Extended release quetiapine (quetiapine XR) - flexible dose from 300 to 600 mg/d (combination of tablets of 50mg, 200mg and 300mg) oral, daily, 8 weeks length. | 14 |
| Setraline Sertraline - flexible dose from 50 to 200 mg/d (combination of tablets of 50mg and 100mg) oral, daily, 8 weeks length. | 13 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 2 | 2 |
| Overall Study | Lack of Efficacy | 1 | 2 |
| Overall Study | Physician Decision | 1 | 1 |
Baseline characteristics
| Characteristic | Setraline | Total | Quetiapine Extended Release |
|---|---|---|---|
| Age Continuous | 43.3 years STANDARD_DEVIATION 12.6 | 46.07 years STANDARD_DEVIATION 12.6 | 48.5 years STANDARD_DEVIATION 12.5 |
| Clinical Impression Global Scale - Bipolar total score (CGI-BP-M), Continuous | 5.3 score on a scale STANDARD_DEVIATION 0.8 | 5.2 score on a scale STANDARD_DEVIATION 0.8 | 5.1 score on a scale STANDARD_DEVIATION 0.7 |
| Hamilton Anxiety Rating Scale (HARS) total score, Continuous | 17.6 score on a scale STANDARD_DEVIATION 4.46 | 20.04 score on a scale STANDARD_DEVIATION 7.38 | 22.4 score on a scale STANDARD_DEVIATION 4.03 |
| Montgomery Asberg Depression Rating Scale (MADRS) total score, Continuous | 28.2 score on a scale STANDARD_DEVIATION 5.8 | 28.9 score on a scale STANDARD_DEVIATION 5.3 | 29.5 score on a scale STANDARD_DEVIATION 5 |
| Sex: Female, Male Female | 4 Participants | 10 Participants | 6 Participants |
| Sex: Female, Male Male | 9 Participants | 17 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 12 / 14 | 9 / 13 |
| serious Total, serious adverse events | 0 / 14 | 0 / 13 |
Outcome results
Primary
The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
Time frame: baseline, week 2
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology. Safety data were analyzed for patients who received at least one dose of study medication.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Extended Release | The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | -13.1 score on a scale |
| Setraline | The Mean Change From Baseline to Week 2 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | -6.6 score on a scale |
Secondary
Number of Patients Response at Week 1
Number of patients responded to the treatment at week 1, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 1. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Time frame: week 1
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Extended Release | Number of Patients Response at Week 1 | 4 Participants |
| Setraline | Number of Patients Response at Week 1 | 4 Participants |
Secondary
Number of Patients With Remission at Week 1.
Number of patients who achieved remission at week 1, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Time frame: week 1
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Extended Release | Number of Patients With Remission at Week 1. | 6 Participants |
| Setraline | Number of Patients With Remission at Week 1. | 5 Participants |
Secondary
Number of Patients With Remission at Week 2.
Number of patients who achieved remission at week 2, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Time frame: week 2
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Extended Release | Number of Patients With Remission at Week 2. | 6 Participants |
| Setraline | Number of Patients With Remission at Week 2. | 5 Participants |
Secondary
Number of Patients With Remission at Week 4.
Number of patients who achieved remission at week 4, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Time frame: week 4
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Extended Release | Number of Patients With Remission at Week 4. | 3 Participants |
| Setraline | Number of Patients With Remission at Week 4. | 3 Participants |
Secondary
Number of Patients With Remission at Week 8.
Number of patients who achieved remission at week 8, where remission is defined as Montgomery Asberg Depression Rating Scale (MADRS) total score ≤ 10. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Time frame: week 8
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Extended Release | Number of Patients With Remission at Week 8. | 3 Participants |
| Setraline | Number of Patients With Remission at Week 8. | 4 Participants |
Secondary
Number of Patients With Response at Week 2
Number of patients responded to the treatment at week 2, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 2. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Time frame: week 2
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Extended Release | Number of Patients With Response at Week 2 | 8 Participants |
| Setraline | Number of Patients With Response at Week 2 | 2 Participants |
Secondary
Number of Patients With Response at Week 4.
Number of patients responded to the treatment at week 4, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 4. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Time frame: week 4
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Extended Release | Number of Patients With Response at Week 4. | 8 Participants |
| Setraline | Number of Patients With Response at Week 4. | 6 Participants |
Secondary
Number of Patients With Response at Week 8.
Number of patients responded to the treatment at week 8, where response is defined as ≥ 50% reduction in the Montgomery Asberg Depression Rating Scale (MADRS) total score from baseline to week 8. MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms.
Time frame: week 8
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Quetiapine Extended Release | Number of Patients With Response at Week 8. | 8 Participants |
| Setraline | Number of Patients With Response at Week 8. | 5 Participants |
Secondary
The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)
Time frame: baseline, week 1
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Extended Release | The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | -0.79 score on a scale |
| Setraline | The Mean Change From Baseline to Week 1 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | -1.08 score on a scale |
Secondary
The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
Time frame: baseline, week 1
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Extended Release | The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | -9.5 score on a scale |
| Setraline | The Mean Change From Baseline to Week 1 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | -8.6 score on a scale |
Secondary
The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)
Time frame: baseline, week 2
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Extended Release | The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | -1.36 score on a scale |
| Setraline | The Mean Change From Baseline to Week 2 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | -1.00 score on a scale |
Secondary
The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 ( higher scores indicating a greater clinical severity)
Time frame: baseline, week 4
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Extended Release | The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | -2.09 score on a scale |
| Setraline | The Mean Change From Baseline to Week 4 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | -2.56 score on a scale |
Secondary
The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score
HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)
Time frame: baseline, week 4
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Extended Release | The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score | -13.4 score on a scale |
| Setraline | The Mean Change From Baseline to Week 4 in the Hamilton Anxiety Rating Scale (HARS) Total Score | -8.9 score on a scale |
Secondary
The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
Time frame: baseline, week 4
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Extended Release | The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | -16.1 score on a scale |
| Setraline | The Mean Change From Baseline to Week 4 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | -17.7 score on a scale |
Secondary
The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score
CGI-BP-M assesses severity of clinical status. It ranges from a minimum of 1 to a maximum of 7 (higher scores indicating a greater clinical severity)
Time frame: baseline, week 8
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Extended Release | The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | -2.9 score on a scale |
| Setraline | The Mean Change From Baseline to Week 8 in the Clinical Impression Global Scale - Bipolar (CGI-BP-M) Total Score | -2.88 score on a scale |
Secondary
The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score
HARS assesses severity of anxiety symptoms. It ranges from a minimum of 0 to a maximum of 56 (higher scores indicating a greater severity of anxiety symptoms)
Time frame: baseline, week 8
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Extended Release | The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score | -13.1 score on a scale |
| Setraline | The Mean Change From Baseline to Week 8 in the Hamilton Anxiety Rating Scale (HARS) Total Score | -10.6 score on a scale |
Secondary
The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score
MADRS assesses severity of depressive symptoms. It ranges from a minimum of 0 to a maximum of 60 (higher scores indicating a greater severity of depressive symptoms)
Time frame: baseline. week 8
Population: Efficacy analyses of the intent-to-treat (ITT) population (those who received at least one dose of the study medication and had at least one post-baseline efficacy assessment) were conducted using ANCOVA and last observation carried forward (LOCF) methodology.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Quetiapine Extended Release | The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | -19.4 score on a scale |
| Setraline | The Mean Change From Baseline to Week 8 in the Montgomery Asberg Depression Rating Scale (MADRS) Total Score | -18.2 score on a scale |