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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
Beijing HuiLongGuan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Risperidone, Artemisinin, Toxoplasma, Immune

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
July 7, 2011
Last Updated
July 10, 2016
Sponsor
Beijing HuiLongGuan Hospital
Collaborators
Stanley Medical Research Institute
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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.

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

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