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Trial record 86 of 450 for:    QUETIAPINE

A 4-week, Randomized, Rater-blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00642369
Recruitment Status : Completed
First Posted : March 25, 2008
Results First Posted : April 17, 2014
Last Update Posted : April 17, 2014
Sponsor:
Information provided by (Responsible Party):
Bin Zhang, Guang Dong Provincial Mental Health Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: quetiapine fumarate
Drug: haloperidol
Enrollment 60
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Quetiapine Fumarate Haloperidol
Hide Arm/Group Description slow wave sleep% and rapid eye movement sleepin quetiapine fumarate treatment group slow wave sleep% in haloperidol treatment group
Period Title: Overall Study
Started 30 30
Completed 25 24
Not Completed 5 6
Reason Not Completed
Adverse Event             2             3
Withdrawal by Subject             1             0
misdiagnosis             0             1
Lack of Efficacy             2             2
Arm/Group Title Quetiapine Fumarate Haloperidol Total
Hide Arm/Group Description quetiapine fumarate treatment (200-750mg/day) in 28 days haloperidol treatment (6-40mg/day) in 28 days Total of all reporting groups
Overall Number of Baseline Participants 30 30 60
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
<=18 years
3
  10.0%
2
   6.7%
5
   8.3%
Between 18 and 65 years
27
  90.0%
28
  93.3%
55
  91.7%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 30 participants 30 participants 60 participants
25.0  (10.1) 27.9  (6.7) 26.3  (8.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 30 participants 30 participants 60 participants
Female
20
  66.7%
17
  56.7%
37
  61.7%
Male
10
  33.3%
13
  43.3%
23
  38.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
China Number Analyzed 30 participants 30 participants 60 participants
30 30 60
1.Primary Outcome
Title Percentage of Slow Wave Sleep
Hide Description The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Quetiapine Fumarate Haloperidol
Hide Arm/Group Description:
percentage of slow wave sleep in quetiapine fumarate group
percentage of slow wave sleep in haloperidol group
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: percentage of slow wave sleep
percentage at baseline 10.5  (5.5) 8.6  (7.6)
percentage on the 28th day 9.2  (8.0) 6.3  (5.4)
percentage change from baseline to the 28th day -1.4  (1.1) -2.3  (1.8)
2.Primary Outcome
Title Percentage of Rapid Eye Movement Sleep
Hide Description The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF).
Time Frame 28 days
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Quetiapine Fumarate Haloperidol
Hide Arm/Group Description:
percentage of rapid eye movement sleep in quetiapine fumarate group
percentage of rapid eye movement sleep in haloperidol group
Overall Number of Participants Analyzed 30 30
Mean (Standard Deviation)
Unit of Measure: percentage of rapid eye movement sleep
percentage at baseline 12.6  (9.1) 13.2  (5.3)
percentage on the 28th day 16.4  (9.2) 10.4  (11.3)
percentage change from baseline to the 28th day 3.9  (3.2) -2.7  (2.5)
Time Frame 28 days.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine Fumarate Haloperidol
Hide Arm/Group Description quetiapine fumarate treatment (200-750mg/day) in 28 days haloperidol treatment (6-40mg/day) in 28 days
All-Cause Mortality
Quetiapine Fumarate Haloperidol
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Fumarate Haloperidol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine Fumarate Haloperidol
Affected / at Risk (%) Affected / at Risk (%)
Total   0/30 (0.00%)   0/30 (0.00%) 
the present study lasted for only 4 weeks. it might be too short to investigate the effect of quetiapine fumarate and haloperidol on sleep and clinical parameters.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Zhang Bin
Organization: Guang Dong Provinical Mental Health Institute
Phone: 86-20-81888553
EMail: zhang73bin@hotmail.com
Layout table for additonal information
Responsible Party: Bin Zhang, Guang Dong Provincial Mental Health Institute
ClinicalTrials.gov Identifier: NCT00642369     History of Changes
Other Study ID Numbers: D1443L00053
First Submitted: March 18, 2008
First Posted: March 25, 2008
Results First Submitted: December 14, 2009
Results First Posted: April 17, 2014
Last Update Posted: April 17, 2014