Trial Outcomes & Findings for A 4-week, Randomized, Rater-blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia (NCT NCT00642369)
NCT ID: NCT00642369
Last Updated: 2014-04-17
Results Overview
The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
28 days
Results posted on
2014-04-17
Participant Flow
Participant milestones
| Measure |
Quetiapine Fumarate
slow wave sleep% and rapid eye movement sleepin quetiapine fumarate treatment group
|
Haloperidol
slow wave sleep% in haloperidol treatment group
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
25
|
24
|
|
Overall Study
NOT COMPLETED
|
5
|
6
|
Reasons for withdrawal
| Measure |
Quetiapine Fumarate
slow wave sleep% and rapid eye movement sleepin quetiapine fumarate treatment group
|
Haloperidol
slow wave sleep% in haloperidol treatment group
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
3
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
misdiagnosis
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
2
|
2
|
Baseline Characteristics
A 4-week, Randomized, Rater-blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia
Baseline characteristics by cohort
| Measure |
Quetiapine Fumarate
n=30 Participants
quetiapine fumarate treatment (200-750mg/day) in 28 days
|
Haloperidol
n=30 Participants
haloperidol treatment (6-40mg/day) in 28 days
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
27 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
25.0 years
STANDARD_DEVIATION 10.1 • n=5 Participants
|
27.9 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
26.3 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
30 participants
n=5 Participants
|
30 participants
n=7 Participants
|
60 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 daysThe primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF).
Outcome measures
| Measure |
Quetiapine Fumarate
n=30 Participants
percentage of slow wave sleep in quetiapine fumarate group
|
Haloperidol
n=30 Participants
percentage of slow wave sleep in haloperidol group
|
|---|---|---|
|
Percentage of Slow Wave Sleep
percentage at baseline
|
10.5 percentage of slow wave sleep
Standard Deviation 5.5
|
8.6 percentage of slow wave sleep
Standard Deviation 7.6
|
|
Percentage of Slow Wave Sleep
percentage on the 28th day
|
9.2 percentage of slow wave sleep
Standard Deviation 8.0
|
6.3 percentage of slow wave sleep
Standard Deviation 5.4
|
|
Percentage of Slow Wave Sleep
percentage change from baseline to the 28th day
|
-1.4 percentage of slow wave sleep
Standard Deviation 1.1
|
-2.3 percentage of slow wave sleep
Standard Deviation 1.8
|
PRIMARY outcome
Timeframe: 28 daysPopulation: For the need of the statistical analysis, the study group and the control group are 30 evaluable patients respectively. Finally, in consideration of 25% un-evaluable patients after randomisation, there should be 80 patients randomised in this study with 40 patients per arm.
The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF).
Outcome measures
| Measure |
Quetiapine Fumarate
n=30 Participants
percentage of slow wave sleep in quetiapine fumarate group
|
Haloperidol
n=30 Participants
percentage of slow wave sleep in haloperidol group
|
|---|---|---|
|
Percentage of Rapid Eye Movement Sleep
percentage at baseline
|
12.6 percentage of rapid eye movement sleep
Standard Deviation 9.1
|
13.2 percentage of rapid eye movement sleep
Standard Deviation 5.3
|
|
Percentage of Rapid Eye Movement Sleep
percentage on the 28th day
|
16.4 percentage of rapid eye movement sleep
Standard Deviation 9.2
|
10.4 percentage of rapid eye movement sleep
Standard Deviation 11.3
|
|
Percentage of Rapid Eye Movement Sleep
percentage change from baseline to the 28th day
|
3.9 percentage of rapid eye movement sleep
Standard Deviation 3.2
|
-2.7 percentage of rapid eye movement sleep
Standard Deviation 2.5
|
Adverse Events
Quetiapine Fumarate
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Haloperidol
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Zhang Bin
Guang Dong Provinical Mental Health Institute
Phone: 86-20-81888553
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place