Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia - Full Text View

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:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone

U.S. FDA Resources

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 ]

Estimated Enrollment:	200
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

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:

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. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Xiang Yang Zhang, MD, Beijing HuiLongGuan hospital
ClinicalTrials.gov Identifier:	NCT01391403 History of Changes
Other Study ID Numbers:	SMRI 05T-726
Study First Received:	July 7, 2011
Last Updated:	July 11, 2011
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
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Artemisinins
Artemisinine
Risperidone
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 21, 2013