Artemisinin to Reduce The Symptoms of Schizophrenia
|ClinicalTrials.gov Identifier: NCT00753506|
Recruitment Status : Completed
First Posted : September 16, 2008
Results First Posted : February 20, 2012
Last Update Posted : February 28, 2012
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder||Dietary Supplement: Artemisinin Dietary Supplement: Identical looking placebo capsule||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||66 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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
- 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.
- 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) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00753506
|United States, Maryland|
|Sheppard Pratt Health System|
|Towson, Maryland, United States, 21204|
|Principal Investigator:||Faith B Dickerson, PhD, MPH||Stanley Research Program at Sheppard Pratt|