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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: July 12, 2011
Last Update Posted: July 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Stanley Medical Research Institute
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing HuiLongGuan Hospital
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.

Condition Intervention Phase
Schizophrenia Drug: Artemisinin Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Xiang Yang Zhang, Beijing HuiLongGuan Hospital:

Primary Outcome Measures:
  • the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 10 weeks ]

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

Enrollment: 88
Study Start Date: September 2008
Study Completion Date: May 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Artemisinin, anti-toxoplasma
Drug: Artemisinin
400 mg/day
Other Name: Qinghaosu
Placebo Comparator: Placebo
Placebo looks like the active drug, with the same dose.
Other: Placebo

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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391403

Beijing HuiLongGuan hospital
Beijing, China, 100096
Sponsors and Collaborators
Beijing HuiLongGuan Hospital
Stanley Medical Research Institute
Study Chair: Lian Y Cao, MD Beijing HuiLongGuan Hospital
  More Information

Additional Information:
Responsible Party: Xiang Yang Zhang, Director, the Research Center, Beijing HuiLongGuan Hospital
ClinicalTrials.gov Identifier: NCT01391403     History of Changes
Other Study ID Numbers: SMRI 05T-726
First Submitted: July 7, 2011
First Posted: July 12, 2011
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Xiang Yang Zhang, Beijing HuiLongGuan Hospital:

Additional relevant MeSH terms:
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents