Double-Blind Trial of Artemisinin to Reduce The Symptoms of Schizophrenia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Sheppard Pratt Health System
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
- Status
- Completed
- Last Updated
- 14 years ago
Overview
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: 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.
Investigators
Faith Dickerson, PhD, MPH
Head, Stanley Research Program
Sheppard Pratt Health System
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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 Outcomes
- 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.(10 weeks (weeks 2 & 12))