Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Artemisinin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Artemisinin, Toxoplasma, Immune
Eligibility Criteria
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
Sites / Locations
- Beijing HuiLongGuan hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Artemisinin, anti-toxoplasma
Placebo
Arm Description
Artemisinin
Placebo looks like the active drug, with the same dose.
Outcomes
Primary Outcome Measures
the Positive and Negative Syndrome Scale (PANSS)
Secondary Outcome Measures
the Clinical Global Impression (ICG)
UKU Side Effect Rating Scale
the Simpson-Angus Scale for extrapyramidal side effects (SAS)
The Abnormal Involuntary Movement Scale (AIMS)
the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Full Information
NCT ID
NCT01391403
First Posted
July 7, 2011
Last Updated
July 10, 2016
Sponsor
Beijing HuiLongGuan Hospital
Collaborators
Stanley Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT01391403
Brief Title
Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing HuiLongGuan Hospital
Collaborators
Stanley Medical Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Risperidone, Artemisinin, Toxoplasma, Immune
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Artemisinin, anti-toxoplasma
Arm Type
Experimental
Arm Description
Artemisinin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo looks like the active drug, with the same dose.
Intervention Type
Drug
Intervention Name(s)
Artemisinin
Other Intervention Name(s)
Qinghaosu
Intervention Description
400 mg/day
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
400mg/day
Primary Outcome Measure Information:
Title
the Positive and Negative Syndrome Scale (PANSS)
Time Frame
10 weeks
Secondary Outcome Measure Information:
Title
the Clinical Global Impression (ICG)
Time Frame
10 weeks
Title
UKU Side Effect Rating Scale
Time Frame
10 weeks
Title
the Simpson-Angus Scale for extrapyramidal side effects (SAS)
Time Frame
10 weeks
Title
The Abnormal Involuntary Movement Scale (AIMS)
Time Frame
10 weeks
Title
the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time Frame
10 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lian Y Cao, MD
Organizational Affiliation
Beijing HuiLongGuan Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Beijing HuiLongGuan hospital
City
Beijing
ZIP/Postal Code
100096
Country
China
12. IPD Sharing Statement
Links:
URL
http://www.stanleyresearch.org
Description
The Stanley Medical Research Institute (SMRI) is a nonprofit organization supporting research on the causes of, and treatments for, schizophrenia and bipolar disorder. This current study was supported by the SMRI.
Learn more about this trial
Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia
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