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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391403
• Other study ID #: SMRI 05T-726
• Status: Completed
• Phase: Phase 3
• First received: July 7, 2011
• Last updated: July 10, 2016
• Start date: September 2008
• Est. completion date: May 2011

Study information

• Verified date: July 2016
• Source: Beijing HuiLongGuan Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: May 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Artemisinin
400 mg/day

Other:
• Placebo
400mg/day

Locations

Country	Name	City	State
China	Beijing HuiLongGuan hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Beijing HuiLongGuan Hospital	Stanley Medical Research Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Positive and Negative Syndrome Scale (PANSS)		10 weeks	No
Secondary	the Clinical Global Impression (ICG)		10 weeks	No
Secondary	UKU Side Effect Rating Scale		10 weeks	Yes
Secondary	the Simpson-Angus Scale for extrapyramidal side effects (SAS)		10 weeks	Yes
Secondary	The Abnormal Involuntary Movement Scale (AIMS)		10 weeks	Yes
Secondary	the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)		10 weeks	No

External Links

•   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.