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
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Beijing Hui-Long-Guan Hospital:

Primary Outcome Measures:
  • the Positive and Negative Syndrome Scale (PANSS) [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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
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
Other Name: 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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01391403

Locations
China
Beijing HuiLongGuan hospital
Beijing, China, 100096
Sponsors and Collaborators
Beijing Hui-Long-Guan Hospital
Stanley Medical Research Institute
Investigators
Study Chair: Lian Y Cao, MD Beijing Hui-Long-Guan Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Xiang Yang Zhang, Director, the Research Center, Beijing Hui-Long-Guan Hospital
ClinicalTrials.gov Identifier: NCT01391403     History of Changes
Other Study ID Numbers: SMRI 05T-726
Study First Received: July 7, 2011
Last Updated: October 15, 2013
Health Authority: China: Food and Drug Administration

Keywords provided by Beijing Hui-Long-Guan Hospital:
Schizophrenia
Risperidone
Artemisinin
Toxoplasma
Immune

Additional relevant MeSH terms:
Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features
Artemisinine
Artemisinins
Risperidone
Anti-Infective Agents
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Antipsychotic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Serotonin Agents
Serotonin Antagonists
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on October 23, 2014