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

NCT01391403 | Completed Phase 3 DMC

• 1 other identifier: SMRI 05T-726
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Risperidone; Artemisinin; Toxoplasma; Immune

Outcome Measures

Primary Outcomes (1)

• the Positive and Negative Syndrome Scale (PANSS)

  10 weeks

Secondary Outcomes (5)

• the Clinical Global Impression (ICG)

  10 weeks

• UKU Side Effect Rating Scale

  10 weeks

• the Simpson-Angus Scale for extrapyramidal side effects (SAS)

  10 weeks

• The Abnormal Involuntary Movement Scale (AIMS)

  10 weeks

• the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  10 weeks

Study Arms (2)

Artemisinin, anti-toxoplasma

EXPERIMENTAL

Artemisinin

Drug: Artemisinin

Placebo

PLACEBO COMPARATOR

Placebo looks like the active drug, with the same dose.

Other: Placebo

Interventions

Artemisinin DRUG

400 mg/day

Also known as: Qinghaosu

Artemisinin, anti-toxoplasma

Placebo OTHER

400mg/day

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing HuiLongGuan Hospital: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Beijing HuiLongGuan hospital

Beijing, 100096, China

Location

Related 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.

MeSH Terms

Conditions

Schizophrenia

Interventions

artemisinin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Lian Y Cao, MD

  Beijing HuiLongGuan Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, the Research Center

Study Record Dates

• First Submitted: July 7, 2011
• First Posted: July 12, 2011
• Study Start: September 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 12, 2016

Record last verified: 2016-07

Locations

CN (1)