SchizophreniaPhase 3NCT01391403
Artemisinin With Risperidone for First-Episode and Drug-Naive Schizophrenia
A Phase 3 study testing Artemisinin in people with Schizophrenia, run by Beijing HuiLongGuan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Artemisinin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 88 participants
- Where
- 1 siteChina
- Study dates
- Sep 2008to May 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Schizophrenia
- Being tested
- Artemisinin, Placebo
- Keywords
- Schizophrenia, Risperidone, Artemisinin, Toxoplasma, Immune
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtemisininDrug
Also called Qinghaosu
400 mg/day
PlaceboOther
400mg/day
| Study group | Role | What they receive |
|---|---|---|
| Artemisinin, anti-toxoplasma | Experimental | Artemisinin Receives: Drug: Artemisinin |
| Placebo | Placebo comparator | Placebo looks like the active drug, with the same dose. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
the Positive and Negative Syndrome Scale (PANSS)
Measured: 10 weeks
Secondary outcomes (5)
the Clinical Global Impression (ICG)
Measured: 10 weeks
UKU Side Effect Rating Scale
Measured: 10 weeks
the Simpson-Angus Scale for extrapyramidal side effects (SAS)
Measured: 10 weeks
The Abnormal Involuntary Movement Scale (AIMS)
Measured: 10 weeks
the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startSep 2008
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing HuiLongGuan Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Responsible party
- Principal investigator, Xiang Yang Zhang, Beijing HuiLongGuan Hospital
- Investigators
- Lian Y Cao, MD, Study chair, Beijing HuiLongGuan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391403
- Sponsor's protocol ID
- SMRI 05T-726
- Status last verified
- Jul 2016
- First submitted
- 7 Jul 2011
- Last updated
- 12 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01391403
- Acronym / sponsor ID
- SMRI 05T-726
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Risperidone, Artemisinin, Toxoplasma, Immune
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- Beijing HuiLongGuan HospitalUniversity, hospital or other
- Collaborators
- Stanley Medical Research Institute
- Study start
- Sep 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 12 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artemisinin, anti-toxoplasma | Experimental | Drug: ArtemisininArtemisinin |
| Placebo | Placebo comparator | Other: PlaceboPlacebo looks like the active drug, with the same dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArtemisininAlso: Qinghaosu400 mg/day | Drug | Artemisinin, anti-toxoplasma |
| Placebo400mg/day | Other | Placebo |
Primary outcome
the Positive and Negative Syndrome Scale (PANSS)
Time frame: 10 weeks
5 secondary outcomes
the Clinical Global Impression (ICG)
Time frame: 10 weeks
UKU Side Effect Rating Scale
Time frame: 10 weeks
the Simpson-Angus Scale for extrapyramidal side effects (SAS)
Time frame: 10 weeks
The Abnormal Involuntary Movement Scale (AIMS)
Time frame: 10 weeks
the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2016.
- 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.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lian Y Cao, MD study chair
Beijing HuiLongGuan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Artemisinin in people with Schizophrenia, run by Beijing HuiLongGuan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Positive and Negative Syndrome Scale (PANSS) (time frame: 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2016.