Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia
NCT ID: NCT01391403
Last Updated: 2016-07-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
88 participants
INTERVENTIONAL
2008-09-30
2011-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Artemisinin, anti-toxoplasma
Artemisinin
Artemisinin
400 mg/day
Placebo
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Placebo
400mg/day
Interventions
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Artemisinin
400 mg/day
Placebo
400mg/day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of schizophrenia or schizophreniform disorder
* Duration of symptoms is no longer than 60 months
* No history of treatment with antipsychotic medication or, if previously treated, a total lifetime usage of less than 14 days
* Current psychotic symptoms are of moderate severity or greater as measured by one of the five psychotic items in the Brief Psychiatric Rating Scale (BPRS)
Exclusion Criteria
* Documented disease of the central nervous system that might interfere with the trial assessments (e.g., stroke, tumor, Parkinson's disease, Huntington's disease, seizure disorder, history of brain trauma resulting in significant impairment, chronic infection)
* Acute, unstable, and/or significant and untreated medical illness (e.g., infection, unstable diabetes, uncontrolled hypertension)
* A clinically significant echocardiogram (ECG) abnormality in the opinion of the investigator
* Pregnant or breastfeeding
* Use of prohibited concomitant therapy
* History of severe allergy or hypersensitivity
* Dependence on alcohol or illegal drugs
* Use of any of the following medications during the trial: antipsychotic medications other than risperidone; psychostimulants; or antidepressants
18 Years
65 Years
ALL
No
Sponsors
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Stanley Medical Research Institute
OTHER
Beijing HuiLongGuan Hospital
OTHER
Responsible Party
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Xiang Yang Zhang
Director, the Research Center
Principal Investigators
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Lian Y Cao, MD
Role: STUDY_CHAIR
Beijing HuiLongGuan Hospital
Locations
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Beijing HuiLongGuan hospital
Beijing, , China
Countries
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Related Links
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The Stanley Medical Research Institute (SMRI) is a nonprofit organization supporting research on the causes of, and treatments for, schizophrenia and bipolar disorder. This current study was supported by the SMRI.
Other Identifiers
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SMRI 05T-726
Identifier Type: -
Identifier Source: org_study_id
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