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This study will apply polysomnography (PSG) to evaluate the effect of quetiapine fumarate on sleep architecture. Most of previous studies evaluated sleep by self-reported questionnaires during the antipsychotic treatment (clozapine, risperidone, olanzapine, et al), while only a few studies with PSG evaluation had some limitation, such as: small sample size, respective or cross-sectional, potential sleep disorders, et al. In this study, we will investigate both subjective and objective effect of quetiapine fumarate in improving sleep quality in schizophrenic patients by PSG as well as psychiatric scales. The control drug in this study is the typical antipsychotic - haloperidol. It could increase sleep duration and efficiency by mostly increasing the S2 without effect on rapid eye movement (REM) sleep and slow wave sleep (SWS). The patients will be randomised into two groups as a parallel design. This study is designed as rater blinded to reduce the bias in evaluation. It is suggested that the sedative effect of quetiapine fumarate could diminish in 2 weeks, therefore, we use 4 weeks to ensure the change of sleep quality in this study, which could be helpful for the evaluation of relative short and middle term effect of quetiapine fumarate on sleep quality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| quetiapine fumarate | Experimental | quetiapine fumarate was administered 25mg on the 1st day,738±41mg/day on the 14th day, and 738±48mg/day on the 28th day. |
|
| haloperidol | Active Comparator | haloperidol was administered 2mg on the 1st day,16±7mg/day on the 14th day, and 18±6mg/day on the 28th day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| quetiapine fumarate | Drug | 600-750mg/day |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Slow Wave Sleep | The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF). | 28 days |
| Percentage of Rapid Eye Movement Sleep | The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF). | 28 days |
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Inclusion Criteria:
For inclusion in the study patients must fulfill all of the following criteria:
Exclusion Criteria:
Any of the following is regarded as a criterion for exclusion from the study:
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| Name | Affiliation | Role |
|---|---|---|
| Zhang Bin, Ph. D | Guang Dong Provincial Mental Health Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangdong Provincial Mental Health Institute | Guangzhou | Guangdong | 510120 | China |
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine Fumarate | slow wave sleep% and rapid eye movement sleepin quetiapine fumarate treatment group |
| FG001 | Haloperidol | slow wave sleep% in haloperidol treatment group |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine Fumarate | quetiapine fumarate treatment (200-750mg/day) in 28 days |
| BG001 | Haloperidol | haloperidol treatment (6-40mg/day) in 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Slow Wave Sleep | The primary variable is the change of percentage of slow wave sleep (SWS) from baseline to the 28th day (LOCF). | Posted | Mean | Standard Deviation | percentage of slow wave sleep | 28 days |
|
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28 days.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quetiapine Fumarate | quetiapine fumarate treatment (200-750mg/day) in 28 days |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Zhang Bin | Guang Dong Provinical Mental Health Institute | 86-20-81888553 | zhang73bin@hotmail.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000069348 | Quetiapine Fumarate |
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D003987 | Dibenzothiazepines |
| D013841 | Thiazepines |
| D013846 | Thiepins |
| D013457 | Sulfur Compounds |
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| haloperidol | Drug | 6-40mg/day |
|
| misdiagnosis |
|
| Lack of Efficacy |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| Primary | Percentage of Rapid Eye Movement Sleep | The primary variable is the change of the percentage of rapid eye movement (REM)sleep from baseline to the 28th day (LOCF). | 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. | Posted | Mean | Standard Deviation | percentage of rapid eye movement sleep | 28 days |
|
|
|
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Haloperidol | haloperidol treatment (6-40mg/day) in 28 days | 0 | 30 | 0 | 30 |
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| D009930 |
| Organic Chemicals |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D002090 | Butyrophenones |
| D007659 | Ketones |
| percentage change from baseline to the 28th day |
|