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

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ClinicalTrials.gov Identifier: NCT01391403
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : July 12, 2016
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Xiang Yang Zhang, Beijing HuiLongGuan Hospital

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Artemisinin Other: Placebo Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 88 participants
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
Study Start Date : September 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
Drug Information available for: Risperidone
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Artemisinin, anti-toxoplasma
Artemisinin
Drug: Artemisinin
400 mg/day
Other Name: Qinghaosu
Placebo Comparator: Placebo
Placebo looks like the active drug, with the same dose.
Other: Placebo
400mg/day



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

Secondary Outcome Measures :
  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 ]


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
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

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


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

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 Posted: July 12, 2011    Key Record Dates
Last Update Posted: July 12, 2016
Last Verified: July 2016

Keywords provided by Xiang Yang Zhang, Beijing HuiLongGuan Hospital:
Schizophrenia
Risperidone
Artemisinin
Toxoplasma
Immune

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Risperidone
Artemisinins
Artemisinine
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
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents