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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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21 July 2016 |
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Main ID: |
NCT02192723 |
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Date of registration:
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15/07/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Randomized Double-blind Trial With 6 Antipsychotic Drugs for Schizophrenia
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Scientific title:
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Effectiveness of 6 Antipsychotic Drugs in the Treatment of Acute Exacerbations of Chronic Inpatients With Schizophrenia: a Randomized Double-blind Study |
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Date of first enrolment:
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June 2012 |
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Target sample size:
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550 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02192723 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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China
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Contacts
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Name:
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Zhi-Ren Wang, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Beijing HuiLongGuan Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients' diagnoses is based on the results of the Structured Clinical Interview for
DSM (SCID) using the criteria of the fourth edition of the Diagnostic and Statistical
Manual (DSM-IV), physical exams and routine chemistry, and hematology laboratory
tests. Attending-level psychiatrists will use a Chinese translation of the SCID to
interview patients and their family members, who are given freedom to ask additional
questions if respondents do not understand the standard probes.
- Patients must meet the following criteria: (1) diagnosis of schizophrenia; (2)
duration of illness more than 2 years; (3) between 25 and 60 years of age; and (5)
have NOT received antipsychotic medication for at least 1 month;(6) acute
exacerbations of chronic inpatients.
- A complete medical history, electroencephalograms and electrocardiogram are obtained,
and a physical examination and laboratory tests are performed at study entrance. None
of the study participants have abnormal findings on these tests.
Exclusion Criteria:
Age minimum:
25 Years
Age maximum:
60 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Schizophrenia
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Intervention(s)
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Device: Aripiprazole
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Drug: Quetiapine
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Drug: Risperidone
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Drug: Typical antipsychotic
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Drug: Olanzapine
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Drug: Ziprasidone
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Primary Outcome(s)
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Positive and Negative Syndrome Scale (PANSS)
[Time Frame: Baseline, 8 weeks]
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Secondary Outcome(s)
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Clinical Global Impression (CGI)
[Time Frame: Baseline, 8 weeks]
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Secondary ID(s)
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Project863
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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