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Artemisinin to Reduce The Symptoms of Schizophrenia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00753506
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : February 20, 2012
Last Update Posted : February 28, 2012
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Faith Dickerson, PhD, MPH, Sheppard Pratt Health System

Study Description
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Brief Summary:
The investigators intend to explore the hypothesis that symptoms of schizophrenia may be reduced by the antimalarial compound artemisinin when used in addition to standard antipsychotic medications.

Condition or disease Intervention/treatment Phase
Schizophrenia Schizoaffective Disorder Dietary Supplement: Artemisinin Dietary Supplement: Identical looking placebo capsule Not Applicable

Detailed Description:

The aims of the current study are:

  1. To evaluate the efficacy and side effects of artemisinin as an add-on compound for patients with schizophrenia who have residual psychotic symptoms of at least moderate severity.
  2. To evaluate the effect of artemisinin on cognitive impairments and associated functional skills.
  3. To investigate whether treatment with artemisinin produces a significant effect on the levels of antibodies to Toxoplasma.
  4. To examine whether changes in cognitive impairment or psychiatric symptoms are correlated with changes in antibodies to Toxoplasma before and during the treatment with artemisinin.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind Trial of Artemisinin to Reduce The Symptoms of Schizophrenia
Study Start Date : August 2008
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Artemisinin
100 mg artemisinin capsule
 Dietary Supplement: Artemisinin
100 mg of artemisinin twice per day for 10 weeks
Placebo Comparator: Placebo
Identical looking placebo capsule
 Dietary Supplement: Identical looking placebo capsule
Identical looking placebo twice per day for 10 weeks


Outcome Measures
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Primary Outcome Measures :
  1. 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) ]
    The Positive and Negative Syndrome Scale (PANSS) measures psychiatric symptomatology, especially related to psychosis. The complete PANSS contains ratings for 30 symptoms, including 7 positive symptoms, 7 negative symptoms, and 16 general psychiatric symptoms. The severity of each symptom is rated on a scale ranging from 1 (minimal) to 7 (extreme); higher scores indicate increased symptomatology. Total PANSS scores include scores from all categories and range from 30 to 210 units on a scale. PANSS positive symptom scores and negative symptom scores each range from 7 to 49 units on a scale.


Secondary Outcome Measures :
  1. 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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Age 18-65 years old.
  • Capacity for written informed consent.
  • Primary Axis I diagnosis (DSM-IV) of schizophrenia, any type, OR schizoaffective disorder (APA, 1994).
  • Currently an outpatient at the time of enrollment.
  • Residual psychotic symptoms which are at least moderately severe as evidenced by one or more Positive and Negative Syndrome Scale (PANSS) positive symptom scores, and/or PANSS negative symptom scores of 4 or more; OR a total PANSS score of 50 or more, containing at least three positive or negative items with scores of 3 or more at screening.
  • Conformance to Patient Outcome Research Team (PORT) Treatment Recommendation #5, Maintenance Antipsychotic Medication Dose (Lehman et al., 2004).
  • Receiving antipsychotic medication for at least 8 weeks prior to starting the study with no medication changes within the previous 21 days.
  • Participants must be proficient in English.

Exclusion Criteria

  • Diagnosis of mental retardation.
  • History of IV drug use.
  • Any serious medical condition that affects brain or cognitive functioning (e.g., epilepsy, serious head injury, brain tumor or other neurological disorder).
  • HIV infection or other immunodeficiency condition.
  • Primary diagnosis of substance abuse or dependence according to DSM-IV criteria within the last three months.
  • Participated in any investigational drug trial in the past 30 days.
  • Pregnancy or planning to become pregnant during the study period.
  • Any clinically significant or unstable medical disorder as determined by the investigators that would preclude study participation, including congestive heart failure, abnormal liver function or disease, renal failure, and any diagnosis of cancer undergoing active treatment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753506


Locations
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United States, Maryland
Sheppard Pratt Health System
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Sheppard Pratt Health System
Stanley Medical Research Institute
Investigators
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Principal Investigator: Faith B Dickerson, PhD, MPH Stanley Research Program at Sheppard Pratt
More Information
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Publications of Results:

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Responsible Party: Faith Dickerson, PhD, MPH, Head, Stanley Research Program, Sheppard Pratt Health System
ClinicalTrials.gov Identifier: NCT00753506    
Other Study ID Numbers: SMRI/SPHS: 2007-02
First Posted: September 16, 2008    Key Record Dates
Results First Posted: February 20, 2012
Last Update Posted: February 28, 2012
Last Verified: February 2012
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Artemisinins
 Artemisinin
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents