N/A
N=66
Artemisinin to Reduce The Symptoms of Schizophrenia
Schizophrenia · Schizoaffective Disorder
Bottom Line
View on ClinicalTrials.gov: NCT00753506 ↗Enrolled (actual)
66
Serious AEs
9.1%
Results posted
Feb 2012
Primary outcome: 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 — 64; 68.13; 61.42; 66.32 units on a scale — p=>0.10
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Artemisinin (Dietary_supplement); Identical looking placebo capsule (Dietary_supplement)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sheppard Pratt Health System
- Primary completion
- May 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
64; 68.13; 61.42; 66.32; 15.42; 16.26 | >0.10 |
| 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. |
— | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00753506). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.