Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier:
NCT01391403
First received: July 7, 2011
Last updated: October 15, 2013
Last verified: October 2013

July 7, 2011
October 15, 2013
September 2008
April 2011   (final data collection date for primary outcome measure)
the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01391403 on ClinicalTrials.gov Archive Site
  • the Clinical Global Impression (ICG) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  • UKU Side Effect Rating Scale [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • the Simpson-Angus Scale for extrapyramidal side effects (SAS) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • The Abnormal Involuntary Movement Scale (AIMS) [ Time Frame: 10 weeks ] [ Designated as safety issue: Yes ]
  • the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Artemisinin
    400 mg/day
    Other Name: Qinghaosu
  • Other: Placebo
    400mg/day
    Other Name: Placebo
  • Experimental: Artemisinin, anti-toxoplasma
    Artemisinin
    Intervention: Drug: Artemisinin
  • Placebo Comparator: Placebo
    Placebo looks like the active drug, with the same dose.
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
88
May 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01391403
SMRI 05T-726
Yes
Xiang Yang Zhang, Beijing Hui-Long-Guan Hospital
Beijing Hui-Long-Guan Hospital
Stanley Medical Research Institute
Study Chair: Lian Y Cao, MD Beijing Hui-Long-Guan Hospital
Beijing Hui-Long-Guan Hospital
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP