Clinical trial NCT00753506: Artemisinin to Reduce The Symptoms of Schizophrenia
Official title: Double-Blind Trial of Artemisinin to Reduce The Symptoms of Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia
Schizoaffective Disorder
Lead sponsor: Sheppard Pratt Health System
Sponsor class: OTHER
Collaborators: name: Stanley Medical Research Institute
First posted: 2008-09-16
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
timeFrame: 10 weeks (weeks 2 & 12)
Secondary outcomes:
measure: 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.
timeFrame: 10 weeks (weeks 2 & 12)
Other outcomes:
Locations:
city: Towson
country: United States
facility: Sheppard Pratt Health System
state: Maryland
Study officials:
affiliation: Stanley Research Program at Sheppard Pratt
name: Faith B Dickerson, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.