Status:
COMPLETED
A 4-week, Randomized, Rater-blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia
Lead Sponsor:
Guang Dong Provincial Mental Health Institute
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 ant...
Detailed Description
1. The objective sleep structures of quetiapine fumarate and haloperidol being used as mono-therapy respectively in the treatment of patients with acute schizophrenia are measured by the change of com...
Eligibility Criteria
Inclusion
- For inclusion in the study patients must fulfill all of the following criteria:
- Provision of written informed consent by patient or his/her legal guardian
- Hospitalized for a diagnosis of Schizophrenia paranoid subtype by Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition (DSM-IV)
- Positive and Negative Syndrome Scale (PANSS) total score≥60
- 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
- Able to understand and comply with the requirements of the study
Exclusion
- Any of the following is regarded as a criterion for exclusion from the study:
- Pregnancy or lactation
- Any DSM-IV Axis I disorder not defined in the inclusion criteria
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Known intolerance or lack of response to quetiapine fumarate or/and haloperidol, as judged by the investigator
- 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
- 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
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation
- Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV criteria
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
- Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment
- Unstable or inadequately treated medical illness (e.g. congestive heart failure, angina pectoris, hypertension) as judged by the investigator
- Organic changes was founded by brain CT
- Involvement in the planning and conduct of the study
- Previous enrolment or randomisation of treatment in the present study.
- Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirements
- 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.
- An absolute neutrophil count (ANC) of 1.5 x 109/L
- Sleep disorder such as Apnea Hypopneas Syndrome, periodic leg movement syndrome and narcolepsy
- The work time is rotate and/or often flies across the time zone
- Use of clozapine within 28 days prior to randomization
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00642369
Start Date
March 1 2008
End Date
October 1 2009
Last Update
April 17 2014
Active Locations (1)
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1
Guangdong Provincial Mental Health Institute
Guangzhou, Guangdong, China, 510120