Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia

Study Overview
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Brief Summary
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This study will determine the effectiveness of artemisinin plus risperidone in improving symptoms and cognitive disturbances and in Chinese people with schizophrenia. The study addresses the Toxoplasma infection hypothesis of schizophrenia.

Detailed Description
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Evidences of high levels of Toxoplasma gondii antibodies in the serum and the cerebrospinal fluid (CSF) of individuals with schizophrenia have suggested that this organism might be involved in the etiopathogenesis of schizophrenia. The investigators hypothesize that antimicrobial therapy by using an add-on agent together with a well-proven neuroleptic may have favorable effects on a subgroup of schizophrenic patients.

Official Title
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A Double-Blind, Randomized, Placebo-Controlled Trial of Artemisinin as an Add-on Therapy to Risperidone in the Treatment of Drug-Naive First-Episode Patients With Schizophrenia

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: Artemisinin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Currently resides in Beijing, China 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: DSM-IV Axis I diagnosis other than schizophrenia or schizophreniform psychosis 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Artemisinin, anti-toxoplasma<br>Artemisinin | Drug: Artemisinin<br>* 400 mg/day<br>* Other names: Qinghaosu;|
| Placebo Comparator: Placebo<br>Placebo looks like the active drug, with the same dose. | Other: Placebo<br>* 400mg/day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Positive and Negative Syndrome Scale (PANSS) |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Clinical Global Impression (ICG) |  | 10 weeks | 
| UKU Side Effect Rating Scale |  | 10 weeks | 
| the Simpson-Angus Scale for extrapyramidal side effects (SAS) |  | 10 weeks | 
| The Abnormal Involuntary Movement Scale (AIMS) |  | 10 weeks | 
| the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) |  | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Risperidone, Artemisinin, Toxoplasma, Immune