Trial Outcomes & Findings for Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression (NCT NCT00883493)
NCT ID: NCT00883493
Last Updated: 2012-07-11
Results Overview
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.
COMPLETED
PHASE3
421 participants
Baseline, 8 weeks
2012-07-11
Participant Flow
First Subject in (FSI): 22 Apr 2009, Last Subject Last Visit (LSLV): 01 Mar 2011, in 9 countries, 29 Psychiatry centres, 421 randomised participants
An enrollment period of up to 7 days and if applicable a wash-out period for 7-28 days depending on the medication being used, ie. antidepressants, antipsychotics and/or mood stabilizers.
Participant milestones
| Measure |
Quetiapine XR
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Overall Study
STARTED
|
212
|
209
|
|
Overall Study
Intention To Treat Analysis Population
|
204
|
195
|
|
Overall Study
Per Protocol Analysis Population
|
162
|
155
|
|
Overall Study
COMPLETED
|
166
|
159
|
|
Overall Study
NOT COMPLETED
|
46
|
50
|
Reasons for withdrawal
| Measure |
Quetiapine XR
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Overall Study
Adverse Event
|
11
|
12
|
|
Overall Study
Lack of Efficacy
|
4
|
3
|
|
Overall Study
Lost to Follow-up
|
7
|
6
|
|
Overall Study
Withdrawal by Subject
|
11
|
20
|
|
Overall Study
Eligibility Criteria not fullfilled
|
6
|
6
|
|
Overall Study
Study specific disc. criteria
|
2
|
0
|
|
Overall Study
Other
|
5
|
3
|
Baseline Characteristics
Efficacy and Safety of Quetiapine Versus Quetiapine Plus Lithium in Bipolar Depression
Baseline characteristics by cohort
| Measure |
Quetiapine XR
n=204 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=195 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
Total
n=399 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
40.6 Years
STANDARD_DEVIATION 10.8 • n=93 Participants
|
39.9 Years
STANDARD_DEVIATION 12.1 • n=4 Participants
|
40.3 Years
STANDARD_DEVIATION 11.4 • n=27 Participants
|
|
Age, Customized
|
40 years
n=93 Participants
|
40 years
n=4 Participants
|
40 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=93 Participants
|
138 Participants
n=4 Participants
|
285 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=93 Participants
|
57 Participants
n=4 Participants
|
114 Participants
n=27 Participants
|
|
Body weight
|
72.8 Kilograms
STANDARD_DEVIATION 16.3 • n=93 Participants
|
72.3 Kilograms
STANDARD_DEVIATION 15.4 • n=4 Participants
|
72.5 Kilograms
STANDARD_DEVIATION 15.8 • n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeksPopulation: The analysis population was "Per Protocol" (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.
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.
Outcome measures
| Measure |
Quetiapine XR
n=162 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=155 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score.
|
23.7 scores on a scale
Standard Deviation 8.4
|
24.3 scores on a scale
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: baseline, week 8Population: The analysis population was "Per Protocol" (PP).This population included all randomized patients, classified according to medication actually received, who took study medication with not less than 75% compliance and who had a randomisation MADRS assessment and all post-randomisation MADRS assessments within pre-defined time windows at each visit.
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.
Outcome measures
| Measure |
Quetiapine XR
n=162 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=155 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Response Rate for MADRS.
|
93.2 percentage of participants
5,0 • Interval 5.0 to 6.9
|
92.9 percentage of participants
4,3 • Interval 4.3 to 6.2
|
SECONDARY outcome
Timeframe: Baseline, 8 WeeksPopulation: The analysis population was "Per Protocol" (PP).
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.
Outcome measures
| Measure |
Quetiapine XR
n=162 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=155 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Hamilton Rating Scale for Depression (HAM-D) Total Score.
|
20.5 scores on a scale
Standard Deviation 7.0
|
21.0 scores on a scale
Standard Deviation 6.1
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: The analysis population was "Per Protocol" (PP).
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).
Outcome measures
| Measure |
Quetiapine XR
n=162 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=155 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Change in Hamilton Rating Scale for Anxiety (HAM-A) Total Score
|
17.5 scores on a scale
Standard Deviation 8.2
|
17.7 scores on a scale
Standard Deviation 8.2
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: The analysis population was "Per Protocol" (PP).
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.
Outcome measures
| Measure |
Quetiapine XR
n=162 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=155 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Change in the Clinical Global Impression Severity (CGI-S) Score.
|
3.1 scores on a scale
Standard Deviation 1.4
|
3.3 scores on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: The analysis population was "Per Protocol" (PP).
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).
Outcome measures
| Measure |
Quetiapine XR
n=162 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=155 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Change in Young Mania Rating Scale (YMRS) Total Score.
|
2.3 scores on a scale
Standard Deviation 1.8
|
2.2 scores on a scale
Standard Deviation 1.7
|
SECONDARY outcome
Timeframe: Baseline, 8 weeksPopulation: The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.
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.
Outcome measures
| Measure |
Quetiapine XR
n=75 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=67 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Change in the Pittsburgh Sleep Quality Index (PSQI)Total Score.
|
3.7 Scores on a scale
95% Confidence Interval -20 • Interval -20.0 to 21.0
|
5.0 Scores on a scale
95% Confidence Interval -16 • Interval -16.0 to 19.0
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.
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.
Outcome measures
| Measure |
Quetiapine XR
n=75 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=64 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Change in Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q) Total Score.
|
-17.9 scores on a scale
Standard Deviation 12.0 • Interval -38.0 to 27.0
|
-18.8 scores on a scale
Standard Deviation 13.4 • Interval -49.0 to 8.0
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.
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.
Outcome measures
| Measure |
Quetiapine XR
n=76 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=66 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Change in the Sheehan Disability Scale (SDS) Total Score.
|
14.4 scores on a scale
95% Confidence Interval -3 • Interval -3.0 to 30.0
|
14.3 scores on a scale
95% Confidence Interval -16 • Interval -16.0 to 30.0
|
SECONDARY outcome
Timeframe: baseline, 8 weeksPopulation: The analysis has been performed in modified Per Protocol (PP) population as this Outcome Measure was included after protocol amendment at the stage the recruitment period was already on-going.
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.
Outcome measures
| Measure |
Quetiapine XR
n=69 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=42 Participants
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Treatment Satisfaction Questionnaire (TSQ) Scores.
Effectivenes, baseline
|
42.7 Scores on a scale
Standard Deviation 20.2 • Interval 15.3 to 100.0
|
36.7 Scores on a scale
Standard Deviation 23.7 • Interval 22.2 to 100.0
|
|
Treatment Satisfaction Questionnaire (TSQ) Scores.
Effectivenes, week 8
|
68.7 Scores on a scale
Standard Deviation 24.9
|
66.7 Scores on a scale
Standard Deviation 21.8
|
|
Treatment Satisfaction Questionnaire (TSQ) Scores.
Side effects, baseline
|
41.7 Scores on a scale
Standard Deviation 25.9
|
44.4 Scores on a scale
Standard Deviation 24.9
|
|
Treatment Satisfaction Questionnaire (TSQ) Scores.
Side effects, week 8
|
58.2 Scores on a scale
Standard Deviation 26.7
|
50.4 Scores on a scale
Standard Deviation 17.0
|
|
Treatment Satisfaction Questionnaire (TSQ) Scores.
Convenience, baseline
|
53.8 Scores on a scale
Standard Deviation 21.5
|
52.8 Scores on a scale
Standard Deviation 21.8
|
|
Treatment Satisfaction Questionnaire (TSQ) Scores.
Convenience, week 8
|
73.6 Scores on a scale
Standard Deviation 17.1
|
72.9 Scores on a scale
Standard Deviation 17.2
|
|
Treatment Satisfaction Questionnaire (TSQ) Scores.
Global satisfaction, baseline
|
37.4 Scores on a scale
Standard Deviation 26.1
|
35.0 Scores on a scale
Standard Deviation 27.7
|
|
Treatment Satisfaction Questionnaire (TSQ) Scores.
Global satisfaction, week 8
|
69.4 Scores on a scale
Standard Deviation 19.4
|
70.7 Scores on a scale
Standard Deviation 18.9
|
Adverse Events
Quetiapine XR
Quatiapine XR + Lithium
Serious adverse events
| Measure |
Quetiapine XR
n=212 participants at risk
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=209 participants at risk
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization due to suicide risk
|
0.00%
0/212
|
0.48%
1/209
|
|
Gastrointestinal disorders
Constipation
|
0.47%
1/212
|
0.48%
1/209
|
|
Infections and infestations
Peritonitis
|
0.47%
1/212
|
0.00%
0/209
|
|
Gastrointestinal disorders
Appendicitis
|
0.47%
1/212
|
0.00%
0/209
|
|
Nervous system disorders
Somnolance
|
0.47%
1/212
|
0.00%
0/209
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/212
|
0.48%
1/209
|
|
Nervous system disorders
Confusion
|
0.00%
0/212
|
0.48%
1/209
|
|
Nervous system disorders
Exacerbation of symptoms
|
0.47%
1/212
|
0.00%
0/209
|
|
Injury, poisoning and procedural complications
Burn
|
0.00%
0/212
|
0.48%
1/209
|
Other adverse events
| Measure |
Quetiapine XR
n=212 participants at risk
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg.
|
Quatiapine XR + Lithium
n=209 participants at risk
Quetiapine XR administered once daily in oral tablet form, Day 1: 50 mg, Day 2: 100 mg, Day 3: 200 mg, Day 4 onwards: 300 mg. Lithium carbonate administered twice daily from Day 1 to Day 56. From Day 1 to Day 7, the total daily dose within the dose range 300 mg/day to 1800 mg/day. From Day 8 to Day 56, the total daily dose adjusted from 600 to 1800 mg/day.
|
|---|---|---|
|
Nervous system disorders
Dry mouth
|
23.6%
50/212
|
22.5%
47/209
|
|
Nervous system disorders
Somnolance
|
21.7%
46/212
|
23.4%
49/209
|
|
Nervous system disorders
Headache
|
13.2%
28/212
|
12.0%
25/209
|
|
Nervous system disorders
Anxiety
|
9.9%
21/212
|
6.7%
14/209
|
|
Gastrointestinal disorders
Constipation
|
9.4%
20/212
|
8.1%
17/209
|
|
Nervous system disorders
Dizziness
|
7.5%
16/212
|
15.3%
32/209
|
|
Gastrointestinal disorders
Diarrhea
|
6.6%
14/212
|
6.2%
13/209
|
|
Gastrointestinal disorders
Nausea
|
6.6%
14/212
|
13.9%
29/209
|
|
Nervous system disorders
Increased appetite
|
6.1%
13/212
|
2.4%
5/209
|
|
Nervous system disorders
Tremor
|
5.2%
11/212
|
13.4%
28/209
|
|
Nervous system disorders
Sedation
|
4.2%
9/212
|
5.3%
11/209
|
|
General disorders
Weight gain
|
3.8%
8/212
|
5.3%
11/209
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER