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

NCT01391403 — Phase 3, Completed, 88 participants, Beijing HuiLongGuan Hospital

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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

Registry	NCT01391403
Status	Completed
Phase	Phase 3
Study type	Interventional; randomized, parallel, masking: double, treatment
Enrollment	88 (Actual)
Sponsor	Beijing HuiLongGuan Hospital (Other); collaborators: Stanley Medical Research Institute
Conditions	Schizophrenia
Interventions	Artemisinin, Placebo (Drug, other)
Dates	start 2008-09-01, primary completion 2011-04-01, completion 2011-05-01, first posted 2011-07-12, last updated 2016-07-12
Locations	1 site in China

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Artemisinin, anti-toxoplasma	Experimental	Drug: Artemisinin	Artemisinin
Placebo	Placebo comparator	Other: Placebo	Placebo looks like the active drug, with the same dose.

Artemisinin (Drug), also known as Qinghaosu: 400 mg/day
Placebo (Other): 400mg/day

+Outcome measures

Primary outcomes

the Positive and Negative Syndrome Scale (PANSS) [10 weeks]

Secondary outcomes

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]

+Eligibility

Sex: All, ages: 18 Years to 65 Years

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

+Locations (1)

Facility	City	Country	Status
Beijing HuiLongGuan hospital	Beijing	China

+Investigators

Lian Y Cao, MD, Study chair, Beijing HuiLongGuan Hospital