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Artemisinin to Reduce The Symptoms of Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Faith Dickerson, PhD, MPH, Sheppard Pratt Health System
ClinicalTrials.gov Identifier:
NCT00753506
First received: September 15, 2008
Last updated: February 27, 2012
Last verified: February 2012
History of Changes
Results First Received: August 22, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Schizophrenia
Schizoaffective Disorder
Interventions: Dietary Supplement: Artemisinin
Dietary Supplement: Identical looking placebo capsule

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
We enrolled n=66 participants drawn from the Sheppard Pratt Health System and from rehabilitation and treatment programs in Central Maryland. Dates of recruitment 8/08-1/10.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
We used a two week placebo run in for all participants

Reporting Groups
  Description
Artemisinin Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
Placebo Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.

Participant Flow:   Overall Study
    Artemisinin     Placebo  
STARTED     33     33  
COMPLETED     26     31  
NOT COMPLETED     7     2  
Withdrawal by Subject                 4                 1  
Lost to Follow-up                 2                 0  
Other reason                 1                 1  



  Baseline Characteristics
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Reporting Groups
  Description
Artemisinin Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006).
Placebo Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials.
Total Total of all reporting groups

Baseline Measures
    Artemisinin     Placebo     Total  
Number of Participants  
[units: participants]
 		  33     33     66  
Age  
[units: participants]
 		     
<=18 years     0     0     0  
Between 18 and 65 years     33     33     66  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  45.4  ± 9.0     49.2  ± 9.2     47.3  ± 9.3  
Gender  
[units: participants]
 		     
Female     13     15     28  
Male     20     18     38  
Region of Enrollment  
[units: participants]
 		     
United States     33     33     66  



  Outcome Measures

1.  Primary:   Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12   [ Time Frame: 10 weeks (weeks 2 & 12) ]
  Show Outcome Measure 1

2.  Secondary:   Change in Cognitive Functioning as Measured by the Repeatable Battery for the Assessment of Neuropsychological Status and Change in Functional Performance as Measured by the UCSD Performance-based Skills Assessment.   [ Time Frame: 10 weeks (weeks 2 & 12) ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. Faith Dickerson
Organization: Sheppard Pratt
phone: 410-938-4359
e-mail: fdickerson@sheppardpratt.org


Publications of Results:


Responsible Party: Faith Dickerson, PhD, MPH, Sheppard Pratt Health System
ClinicalTrials.gov Identifier: NCT00753506     History of Changes
Other Study ID Numbers: SMRI/SPHS: 2007-02
Study First Received: September 15, 2008
Results First Received: August 22, 2011
Last Updated: February 27, 2012
Health Authority: United States: Institutional Review Board