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A 4-Week, Randomized, Rater-Blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia
This study is currently recruiting participants.
Verified by Guang Dong Provincial Mental Health Institute, March 2008
Sponsored by: Guang Dong Provincial Mental Health Institute
Information provided by: Guang Dong Provincial Mental Health Institute
ClinicalTrials.gov Identifier: NCT00642369
  Purpose

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

MedlinePlus related topics: Mental Health Schizophrenia
Drug Information available for: Quetiapine Quetiapine fumarate Haloperidol Haloperidol decanoate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Further study details as provided by Guang Dong Provincial Mental Health Institute:

Primary Outcome Measures:
  • The primary objective is to evaluate the effect of quetiapine fumarate on sleep structures as mono-therapy in the treatment of patients with acute schizophrenia. [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The efficacy of quetiapine as mono-therapy in improving sleep quality in acute schizophrenia [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • The efficacy of quetiapine as mono-therapy in acute schizophrenia [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • The safety and tolerability of quetiapine as mono-therapy in acute schizophrenia [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For inclusion in the study patients must fulfill all of the following criteria:

  1. Provision of written informed consent by patient or his/her legal guardian
  2. Hospitalized for a diagnosis of Schizophrenia paranoid subtype by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
  3. PANSS total score≥60
  4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chronic gonadotropin (HCG) test at enrolment
  5. Able to understand and comply with the requirements of the study

Exclusion Criteria:

Any of the following is regarded as a criterion for exclusion from the study:

  1. Pregnancy or lactation
  2. Any DSM-IV Axis I disorder not defined in the inclusion criteria
  3. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
  4. Known intolerance or lack of response to quetiapine fumarate or/and haloperidol, as judged by the investigator
  5. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir, ritonavir, fluvoxamine and saquinavir
  6. Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John's Wort, and glucocorticoids
  7. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
  8. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
  9. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
  10. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
  11. Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
  12. Organic changes was founded by brain CT
  13. Involvement in the planning and conduct of the study
  14. Previous enrolment or randomisation of treatment in the present study.
  15. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
  16. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%; admitted to hospital for treatment of DM or DM related illness in past 12 weeks; not under physician care for DM Physician responsible for patient's DM care has not indicated that patient's DM is controlled; Physician responsible for patient's DM care has not approved patient's participation in the study; has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomisation; for thiazolidinediones (glitazones) this period should not be less than 8 Weeks; taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks. Note: If a diabetic patient meets one of these criteria, the patient is to be excluded even if the treating physician believes that the patient is stable and can participate in the study.
  17. An absolute neutrophil count (ANC) of 1.5 x 109/L
  18. Sleep disorder such as Apnea Hypopneas Syndrome, PLMS and narcolepsy
  19. The work time is rotate and/or often flies across the time zone
  20. Use of clozapine within 28 days prior to randomization
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00642369

Contacts
Contact: Bin Zhang, Ph.D 8620-81884713 ext 80811 zhang73bin@yahoo.com.cn

Locations
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    
Sponsors and Collaborators
Guang Dong Provincial Mental Health Institute
Investigators
Principal Investigator: Zhang Bin, Ph. D Guang Dong Provincial Mental Health Institute
  More Information

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

Keywords provided by Guang Dong Provincial Mental Health Institute:
Polysomnograph

Study placed in the following topic categories:
Haloperidol
Schizophrenia
Haloperidol decanoate
Quetiapine
Dopamine
Mental Disorders
Psychotic Disorders
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on January 16, 2009