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

Beijing HuiLongGuan Hospital

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Treatments

Other: Placebo

Drug: Artemisinin

Study type

Interventional

Funder types

Other

Identifiers

NCT01391403

SMRI 05T-726

Details and patient eligibility

About

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.

Full 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.

Enrollment

88 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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