A Phase 3 interventional study of Quetiapine fumarate XR and Lithium carbonate in Acute Bipolar Depression, sponsored by AstraZeneca. Completed at 24 sites in 9 countries. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-07-11.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The purpose of this study is to compare the efficacy of quetiapine fumarate monotherapy with quetiapine fumarate in combination with lithium in the treatment of a major depressive episode in patients with bipolar disorder.
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Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Drug: Quetiapine fumarate XR
Quetiapine XR will be administered like monotherapy arm. Lithium will be administered twice daily from Day 1 to Day 56.
Drug: Quetiapine fumarate XR · Drug: Lithium carbonate
Quetiapine XR (extended release) will be administered once daily at bedtime in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
Also known as: SEROQUEL XR
Twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose of lithium could be increased gradually within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose could be adjusted from 600 to 1800 mg/day
Also known as: LITHURIL Tb in TURKEY, LITOCARB in PERU
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks). The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Time frame: Baseline, 8 weeks
Response Rate for MADRS.
Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
Time frame: baseline, week 8
Hamilton Rating Scale for Depression (HAM-D) Total Score.
The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8). HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression.
Time frame: Baseline, 8 Weeks
Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8). The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as "anxious mood", "tension" or "fears". Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max).
Time frame: baseline, 8 weeks
Change in the Clinical Global Impression Severity (CGI-S) Score.
The reported mean change in the CGI-S score was calculated as baseline - week 8. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
Time frame: baseline, 8 weeks
Change in Young Mania Rating Scale (YMRS) Total Score.
The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient's subjective report of his or hers clinical condition over the previous 48 hours. The mean change in YMRS Total score reported was calculated as baseline - week 8. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
Time frame: baseline, 8 weeks
Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.
The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8. PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.
Time frame: Baseline, 8 weeks
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.
The mean change in (Q-LES-Q-Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8). The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life.
Time frame: baseline, 8 weeks
Change in the Sheehan Disability Scale (SDS) Total Score.
The mean change in the SDS Total score from baseline to week 8 (baseline- week 8). Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment.
Time frame: baseline, 8 weeks
Treatment Satisfaction Questionnaire (TSQ) Scores.
The 14-item TAQ questionnaire evaluates the patient's overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication. Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction.
Time frame: baseline, 8 weeks
First Subject in (FSI): 22 Apr 2009, Last Subject Last Visit (LSLV): 01 Mar 2011, in 9 countries, 29 Psychiatry centres, 421 randomised participants
| Milestone | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Started | 212 | 209 |
| Intention to treat analysis population | 204 | 195 |
| Per protocol analysis population | 162 | 155 |
| Completed | 166 | 159 |
| Not completed | 46 | 50 |
| Withdrew: Adverse event | 11 | 12 |
| Withdrew: Lack of efficacy | 4 | 3 |
| Withdrew: Lost to follow-up | 7 | 6 |
| Withdrew: Withdrawal by subject | 11 | 20 |
| Withdrew: Eligibility criteria not fullfilled | 6 | 6 |
| Withdrew: Study specific disc. criteria | 2 | 0 |
| Withdrew: Other | 5 | 3 |
The change of MADRS Total Score from baseline to the end of treatment was calculated by subtracting the MADRS Total Score assessed at week 8 from the baseline one (Baseline - 8 weeks). The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
| scores on a scale | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score. | 23.7 ± 8.4 | 24.3 ± 7.9 |
Response rate defined as the percentage of patients with a ≥50% reduction from baseline in the MADRS total score to the final assessment at week 8. The MADRS is a 10-item scale that evaluates the core symptoms and cognitive features of clinical depression. Each MADRS item is rated on a 0 to 6 scale. The MADRS Total score ranges from 0 (min) to 60 (max). Higher MADRS scores indicate higher levels of depressive symptoms.
| percentage of participants | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Response Rate for MADRS. | 93.2 ± 5,0 | 92.9 ± 4,3 |
The mean change of HAM-D Total Score from baseline to the end of treatment was calculated by subtracting the HAM-D Total Score assessed at week 8 from the baseline one (Baseline - week 8). HAM-D is a multiple choice questionnaire used to rate the severity of a patient's major depression. It consists of 17 different items with possible scores from 0 to 4 or 0 to 2 or 0 to 6 depending on the items. Sum the total of all seventeen items gives the HAM-D Total Score, which may range from 0 (min) to 53 (max). The higher the score, the more severe the depression.
| scores on a scale | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Hamilton Rating Scale for Depression (HAM-D) Total Score. | 20.5 ± 7.0 | 21.0 ± 6.1 |
The mean change in HAM-A total score from baseline to final assessment was calculated by subtracting the HAM-A Total score assessed at week 8 from the total score assessed at the baseline (baseline - week 8). The HAM-A is a 14-item scale that assesses anxiety symptoms of anxiety such as "anxious mood", "tension" or "fears". Each item is scored on a 5-point scale, ranging from 0=not present to 4=severe. Sum the scores from all 14 parameters gives the HAM-A Total Score which may range from 0 (min) to 56 (max).
| scores on a scale | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score | 17.5 ± 8.2 | 17.7 ± 8.2 |
The reported mean change in the CGI-S score was calculated as baseline - week 8. CGI-S is a 7-point scale that requires the clinician to rate the severity of the patient's illness at the time of assessment. A patient is assessed on severity of mental illness at the time of rating 1, normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7, extremely ill.
| scores on a scale | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Change in the Clinical Global Impression Severity (CGI-S) Score. | 3.1 ± 1.4 | 3.3 ± 1.2 |
The YMRS is a rating scale to assess manic symptoms. The scale has 11 items and is based upon patient's subjective report of his or hers clinical condition over the previous 48 hours. The mean change in YMRS Total score reported was calculated as baseline - week 8. The YMRS total score ranges from 0 to 60 where higher scores indicate more severe mania, thus, a negative change (or decrease) from baseline indicates a reduction (or improvement) in manic symptoms. Total score ≤12 indicates remission (13-19=minimal symptoms; 20-25=mild mania, 26-37=moderate mania, 38-60=severe mania).
| scores on a scale | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Change in Young Mania Rating Scale (YMRS) Total Score. | 2.3 ± 1.8 | 2.2 ± 1.7 |
The mean change in PSQI score from baseline to final assessment at week 8 was calculated as baseline - week 8. PSQI evaluates 7 areas of quality and pattern of sleep: sleep quality, duration getting to sleep, sleep duration, sleep adequacy, sleep disturbance, use of sleeping pill, and somnolence). Each area is rated on a scale from 0 (better) to 3 (worse) with a total score ranging from 0 to 21. Reduction in total scores are associated with better sleep quality.
| Scores on a scale | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score. | 3.7 ± -20 | 5.0 ± -16 |
The mean change in (Q-LES-Q-Short Form) Total Score from baseline to week 8 was calculated by subtracting the 8 week value from baseline value (baseline - week 8). The Q-LES-Q-SF is a patient self assessment questionnaire consisting of 16 self-rated questions (1 being very poor - 5 very good); the first 14 will be incorporated into a total score. Higher scores indicate better quality of life.
| scores on a scale | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score. | -17.9 ± 12.0 | -18.8 ± 13.4 |
The mean change in the SDS Total score from baseline to week 8 (baseline- week 8). Sheehan Disability Scale is a 5 item scale, with a visual analog scale evaluating work/school work, social life and family life ranging from 0 to a maximum score of 30. Each one of the 3 domains is rated from 0-10 (no impairment to most severe impairment) with evaluation of not at all (0), mild (1-3), moderate (4-6), marked (7-9) and extreme (10) disability. A total score will be calculated. A score of 30 indicates most severe impairment.
| scores on a scale | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Change in the Sheehan Disability Scale (SDS) Total Score. | 14.4 ± -3 | 14.3 ± -16 |
The 14-item TAQ questionnaire evaluates the patient's overall level of satisfaction with the study medication, the effectiveness, side effects and convenience of the medication. Effectiveness, side effects, convenience and global satisfaction is rated on a scale of 0 being the worst and 100 being very effective, no side effects or very convenient or very satisfied. Overall satisfaction is rated over a score of 5 and 5 being the best overall satisfaction.
| Scores on a scale | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Effectivenes, baseline | 42.7 ± 20.2 | 36.7 ± 23.7 |
| Effectivenes, week 8 | 68.7 ± 24.9 | 66.7 ± 21.8 |
| Side effects, baseline | 41.7 ± 25.9 | 44.4 ± 24.9 |
| Side effects, week 8 | 58.2 ± 26.7 | 50.4 ± 17.0 |
| Convenience, baseline | 53.8 ± 21.5 | 52.8 ± 21.8 |
| Convenience, week 8 | 73.6 ± 17.1 | 72.9 ± 17.2 |
| Global satisfaction, baseline | 37.4 ± 26.1 | 35.0 ± 27.7 |
| Global satisfaction, week 8 | 69.4 ± 19.4 | 70.7 ± 18.9 |
Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Quetiapine XR | — | 5/212 (2.4%) | 147/212 (69.3%) |
| Quatiapine XR + Lithium | — | 5/209 (2.4%) | 149/209 (71.3%) |
| Event | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Hospitalization due to suicide riskPsychiatric disorders | 0/212 | 1/209 |
| ConstipationGastrointestinal disorders | 1/212 | 1/209 |
| HypothyroidismEndocrine disorders | 0/212 | 1/209 |
| ConfusionNervous system disorders | 0/212 | 1/209 |
| BurnInjury, poisoning and procedural complications | 0/212 | 1/209 |
| PeritonitisInfections and infestations | 1/212 | 0/209 |
| AppendicitisGastrointestinal disorders | 1/212 | 0/209 |
| SomnolanceNervous system disorders | 1/212 | 0/209 |
| Exacerbation of symptomsNervous system disorders | 1/212 | 0/209 |
| Event | Quetiapine XR | Quatiapine XR + Lithium |
|---|---|---|
| Dry mouthNervous system disorders | 50/212 | 47/209 |
| SomnolanceNervous system disorders | 46/212 | 49/209 |
| DizzinessNervous system disorders | 16/212 | 32/209 |
| NauseaGastrointestinal disorders | 14/212 | 29/209 |
| TremorNervous system disorders | 11/212 | 28/209 |
| HeadacheNervous system disorders | 28/212 | 25/209 |
| AnxietyNervous system disorders | 21/212 | 14/209 |
| ConstipationGastrointestinal disorders | 20/212 | 17/209 |
| DiarrheaGastrointestinal disorders | 14/212 | 13/209 |
| Increased appetiteNervous system disorders | 13/212 | 5/209 |
| Age Continuous(Years) | Quetiapine XR | Quatiapine XR + Lithium | Total |
|---|---|---|---|
| Mean | 40.6 ± 10.8 | 39.9 ± 12.1 | 40.3 ± 11.4 |
| Age, Customized(years) | Quetiapine XR | Quatiapine XR + Lithium | Total |
|---|---|---|---|
| Median | 40 (19 to 64) | 40 (18 to 65) | 40 (18 to 65) |
| Sex: Female, Male(Participants) | Quetiapine XR | Quatiapine XR + Lithium | Total |
|---|---|---|---|
| Female | 147 | 138 | 285 |
| Male | 57 | 57 | 114 |
| Body weight(Kilograms) | Quetiapine XR | Quatiapine XR + Lithium | Total |
|---|---|---|---|
| Mean | 72.8 ± 16.3 | 72.3 ± 15.4 | 72.5 ± 15.8 |
This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.
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