Trial Outcomes & Findings for A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study (NCT NCT01254721)
NCT ID: NCT01254721
Last Updated: 2014-05-08
Results Overview
The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
131 participants
Primary outcome timeframe
From Baseline to Day 29
Results posted on
2014-05-08
Participant Flow
Participant milestones
| Measure |
Seroquel XR
Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days
|
Seroquel XR + Lithium
Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration \[0.8\~1.2mEq/L\].
Treatment duration: 28 days
|
|---|---|---|
|
Overall Study
STARTED
|
67
|
64
|
|
Overall Study
COMPLETED
|
52
|
42
|
|
Overall Study
NOT COMPLETED
|
15
|
22
|
Reasons for withdrawal
| Measure |
Seroquel XR
Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days
|
Seroquel XR + Lithium
Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration \[0.8\~1.2mEq/L\].
Treatment duration: 28 days
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
|
Overall Study
Lack of Efficacy
|
4
|
2
|
|
Overall Study
Death
|
0
|
1
|
|
Overall Study
technical problum
|
1
|
0
|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
8
|
11
|
|
Overall Study
Wrongly randomization
|
0
|
1
|
Baseline Characteristics
A Comparison of the Effectiveness of Seroquel XR and Seroquel XR Plus Lithium in Patients With Acute Bipolar Mania: An Open-label, Randomized, Parallel Groups, Rater-blinded, 4 Week, Multicenter, Comparative,Study
Baseline characteristics by cohort
| Measure |
Seroquel XR
n=63 Participants
Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days
|
Seroquel XR + Lithium
n=58 Participants
Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration \[0.8\~1.2mEq/L\].
Treatment duration: 28 days
|
Total
n=121 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
Age
|
38.4 Years
STANDARD_DEVIATION 9.8 • n=99 Participants
|
36.9 Years
STANDARD_DEVIATION 11.7 • n=107 Participants
|
37.7 Years
STANDARD_DEVIATION 10.7 • n=206 Participants
|
|
Age, Customized
Age at onset of acute bipolar mania
|
31.0 Years
STANDARD_DEVIATION 10.6 • n=99 Participants
|
30.0 Years
STANDARD_DEVIATION 11.3 • n=107 Participants
|
30.5 Years
STANDARD_DEVIATION 10.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
34 Participants
n=107 Participants
|
71 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
50 Participants
n=206 Participants
|
|
Total No. of acute bipolar mania episodes over lifetime
|
4.24 Episodes
STANDARD_DEVIATION 4.31 • n=99 Participants
|
3.25 Episodes
STANDARD_DEVIATION 2.42 • n=107 Participants
|
3.76 Episodes
STANDARD_DEVIATION 3.54 • n=206 Participants
|
|
Bipolar I Disorder
Manic Episodes
|
57 Number of Patients in ITT analysis set
n=99 Participants
|
51 Number of Patients in ITT analysis set
n=107 Participants
|
108 Number of Patients in ITT analysis set
n=206 Participants
|
|
Bipolar I Disorder
Mixed Episodes
|
6 Number of Patients in ITT analysis set
n=99 Participants
|
7 Number of Patients in ITT analysis set
n=107 Participants
|
13 Number of Patients in ITT analysis set
n=206 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Day 29The Young Mania Rating Scale (YMRS) is an eleven-item, multiple-choice diagnostic questionnaire which psychiatrists use to measure the severity of manic episodes. There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients. Total score is summed of 11items. Total score rage is from 0 to 60 and the higher score represent a worse oucome.
Outcome measures
| Measure |
Seroquel XR
n=63 Participants
Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days
|
Seroquel XR + Lithium
n=58 Participants
Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration \[0.8\~1.2mEq/L\].
Treatment duration: 28 days
|
|---|---|---|
|
The Changes From Baseline in Young Mania Rating Scale (YMRS) Total Score to Day 29
|
-13.7 scores on the scale
Standard Deviation 13.8
|
-15.5 scores on the scale
Standard Deviation 13.3
|
SECONDARY outcome
Timeframe: From Baseline to Day 29The Severity of Illness scale (CGI-S) is scored to rate the patient's current clinical state. The score range is form 0 to 7. A CGI-S score of 1 indicates that a patient is "Normal, not at all ill" and a score of 7 indicates that a patient is "Among the most extremely ill patients".
Outcome measures
| Measure |
Seroquel XR
n=63 Participants
Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days
|
Seroquel XR + Lithium
n=58 Participants
Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration \[0.8\~1.2mEq/L\].
Treatment duration: 28 days
|
|---|---|---|
|
The Change From Baseline up to Day 29 and Final Assessment in the Clinical Global Impression-Severity of Illness Scale (CGI-S)
|
-1.37 scores on the scale
Standard Deviation 1.52
|
-1.58 scores on the scale
Standard Deviation 1.56
|
Adverse Events
Seroquel XR
Serious events: 2 serious events
Other events: 52 other events
Deaths: 0 deaths
Seroquel XR + Lithium
Serious events: 2 serious events
Other events: 49 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Seroquel XR
n=68 participants at risk
Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days
|
Seroquel XR + Lithium
n=62 participants at risk
Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration \[0.8\~1.2mEq/L\].
Treatment duration: 28 days
|
|---|---|---|
|
Psychiatric disorders
MANIC SYMPTOMS AGGRAVATION
|
0.00%
0/68 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
1.6%
1/62 • Number of events 1 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Psychiatric disorders
BIPOLAR MANIA
|
1.5%
1/68 • Number of events 1 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
0.00%
0/62 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Psychiatric disorders
MOOD ELEVATION
|
1.5%
1/68 • Number of events 1 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
0.00%
0/62 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Psychiatric disorders
DEATH
|
0.00%
0/68 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
1.6%
1/62 • Number of events 1 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
Other adverse events
| Measure |
Seroquel XR
n=68 participants at risk
Seroquel XR: 300mg, After that, 400mg to 800mg, Study medication will be administered orally, once daily in the evening.
Treatment duration: 28 days
|
Seroquel XR + Lithium
n=62 participants at risk
Seroquel XR: 300mg, After that, 400mg to 800mg Study medication will be administered orally, once daily in the evening Lithium will be started with 300mg tid on Day 1 then adjusted between the 900mg/day and 1200mg/day from Day 2 within lithium concentration \[0.8\~1.2mEq/L\].
Treatment duration: 28 days
|
|---|---|---|
|
Nervous system disorders
Tremor
|
4.4%
3/68 • Number of events 3 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
9.7%
6/62 • Number of events 6 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Nervous system disorders
Akathisia
|
5.9%
4/68 • Number of events 4 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
8.1%
5/62 • Number of events 5 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Nervous system disorders
Headache
|
8.8%
6/68 • Number of events 6 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
9.7%
6/62 • Number of events 10 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Gastrointestinal disorders
Dyspepsia
|
11.8%
8/68 • Number of events 9 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
4.8%
3/62 • Number of events 4 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Gastrointestinal disorders
Dry mouth
|
4.4%
3/68 • Number of events 4 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
11.3%
7/62 • Number of events 7 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Infections and infestations
Nasopharyngitis
|
7.4%
5/68 • Number of events 6 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
8.1%
5/62 • Number of events 5 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Psychiatric disorders
Insomnia
|
11.8%
8/68 • Number of events 8 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
3.2%
2/62 • Number of events 2 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Gastrointestinal disorders
Constipation
|
29.4%
20/68 • Number of events 21 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
32.3%
20/62 • Number of events 21 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
|
Nervous system disorders
Dizziness
|
8.8%
6/68 • Number of events 6 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
3.2%
2/62 • Number of events 2 • Day1 to Day29
Safety set number is 130 (Seroquel XR 68 and Seroquel XR+Lithium 62)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60