Back to resultsArtemisinin to Reduce The Symptoms of Schizophrenia
Primary Purpose
Schizophrenia, Schizoaffective Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Artemisinin
Identical looking placebo capsule
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility 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.
Sites / Locations
- Sheppard Pratt Health System
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Artemisinin
Placebo
Arm Description
100 mg artemisinin capsule
Identical looking placebo capsule
Outcomes
Primary Outcome Measures
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase 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
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.
Full Information
NCT ID
NCT00753506
First Posted
September 15, 2008
Last Updated
February 27, 2012
Sponsor
Sheppard Pratt Health System
Collaborators
Stanley Medical Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00753506
Brief Title
Artemisinin to Reduce The Symptoms of Schizophrenia
Official Title
Double-Blind Trial of Artemisinin to Reduce The Symptoms of Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheppard Pratt Health System
Collaborators
Stanley Medical Research Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
The aims of the current study are:
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.
To evaluate the effect of artemisinin on cognitive impairments and associated functional skills.
To investigate whether treatment with artemisinin produces a significant effect on the levels of antibodies to Toxoplasma.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Artemisinin
Arm Type
Active Comparator
Arm Description
100 mg artemisinin capsule
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical looking placebo capsule
Intervention Type
Dietary Supplement
Intervention Name(s)
Artemisinin
Intervention Description
100 mg of artemisinin twice per day for 10 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Identical looking placebo capsule
Intervention Description
Identical looking placebo twice per day for 10 weeks
Primary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
Description
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.
Time Frame
10 weeks (weeks 2 & 12)
Secondary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith B Dickerson, PhD, MPH
Organizational Affiliation
Stanley Research Program at Sheppard Pratt
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheppard Pratt Health System
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21546216
Citation
Dickerson F, Stallings C, Vaughan C, Origoni A, Goga J, Khushalani S, Yolken R. Artemisinin reduces the level of antibodies to gliadin in schizophrenia. Schizophr Res. 2011 Jul;129(2-3):196-200. doi: 10.1016/j.schres.2011.04.010. Epub 2011 May 5.
Results Reference
result
Learn more about this trial
Artemisinin to Reduce The Symptoms of Schizophrenia
We'll reach out to this number within 24 hrs