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Completed

NCT Number: NCT01391403

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

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Beijing HuiLongGuan hospital

Beijing, 100096, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Artemisinin

Drug

400 mg/day

Other names: Qinghaosu

Placebo

Other

400mg/day

Primary outcomes

  1. the Positive and Negative Syndrome Scale (PANSS)

    Time frame: 10 weeks

Secondary outcomes

  1. the Clinical Global Impression (ICG)

    Time frame: 10 weeks

  2. UKU Side Effect Rating Scale

    Time frame: 10 weeks

  3. the Simpson-Angus Scale for extrapyramidal side effects (SAS)

    Time frame: 10 weeks

  4. The Abnormal Involuntary Movement Scale (AIMS)

    Time frame: 10 weeks

  5. the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: 10 weeks

Sponsors and collaborators

Lead sponsor

Beijing HuiLongGuan Hospital

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 12, 2011
Registry last updated
Jul 12, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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