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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01391403

Enrollment

Registered

2011-07-12

Start date

2008-09-30

Completion date

2011-05-31

Last updated

2016-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

Schizophrenia, Risperidone, Artemisinin, Toxoplasma, Immune

Brief 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.

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.

Interventions

DRUGArtemisinin

400 mg/day

OTHERPlacebo

400mg/day

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
the Positive and Negative Syndrome Scale (PANSS)	10 weeks

Secondary

Measure	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

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026