Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
Guang Dong Provincial Mental Health Institute |
---|---|
Information provided by: | Guang Dong Provincial Mental Health Institute |
ClinicalTrials.gov Identifier: | NCT00642369 |
Sleep disorders have been recognized by psychiatrists as a range of important symptoms of schizophrenia, which often appear in the exacerbation period as a signal of relapse and increase the risk of suicide. It could be very helpful for the management and prognosis of schizophrenia by a drug that could improve the sleep without over-sedation.
Quetiapine fumarate is a newer atypical antipsychotic with good tolerability. Although sedative effect is common, it will diminish in two weeks without dose adjustment. However, there is no systemic PSG study to investigate the effect of quetiapine on sleep quantity and quality. The systematic PSG study will be helpful to explore such clinical problems as: increasing sleep duration or not, improving the sleep quality by influencing SWS and REM or not, the effect of quetiapine on sleep relating to the prognosis of the positive and negative symptoms or not, and so on.
Since it had the major effect on the 5-HT2A and little effect on 5-HT2C in the 5-HT2 system, quetiapine might not improve the sleep quality by increasing SWS. However, another study on patients with schizophrenia suggested quetiapine could increase SWS duration. It might due to the difference of neurobiological condition between the patients with schizophrenia and the health volunteers. We hypothesized that quetiapine might increase SWS duration in schizophrenia through modifying the neurobiological pathological mechanism.
Condition | Intervention |
---|---|
Schizophrenia |
Drug: quetiapine fumarate Drug: haloperidol |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Estimated Enrollment: | 80 |
Study Start Date: | March 2008 |
Estimated Study Completion Date: | September 2009 |
Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
quetiapine fumarate
|
Drug: quetiapine fumarate
quetiapine fumarate: 600-750mg/day
|
2: Active Comparator
haloperidol
|
Drug: haloperidol
haloperidol: 6-40mg/day
|
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
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:
Contact: Bin Zhang, Ph.D | 8620-81884713 ext 80811 | zhang73bin@yahoo.com.cn |
China, Guangdong Province | |
Guangdong Provincial Mental Health Institute | Recruiting |
Guang Zhou, Guangdong Province, China, 510120 | |
Contact: Zhang Bin, Ph. D 8620-81884713 ext 80811 zhang73bin@yahoo.com.cn |
Principal Investigator: | Zhang Bin, Ph. D | Guang Dong Provincial Mental Health Institute |
Responsible Party: | Guang Dong Provincial Mental Health Institute ( Zhang Bin ) |
Study ID Numbers: | D1443L00053 |
Study First Received: | March 18, 2008 |
Last Updated: | March 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00642369 |
Health Authority: | China: Ethics Committee |
Polysomnograph |
Haloperidol Schizophrenia Haloperidol decanoate Quetiapine |
Dopamine Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
Neurotransmitter Agents Tranquilizing Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Gastrointestinal Agents Psychotropic Drugs Antiemetics Central Nervous System Depressants |
Dopamine Antagonists Antipsychotic Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Dopamine Agents Peripheral Nervous System Agents Central Nervous System Agents |