Artemisinin to Reduce The Symptoms of Schizophrenia

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

66 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Schizophrenia Schizoaffective Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Artemisinin

100 mg artemisinin capsule

Group Type ACTIVE_COMPARATOR

Artemisinin

Intervention Type DIETARY_SUPPLEMENT

100 mg of artemisinin twice per day for 10 weeks

Placebo

Identical looking placebo capsule

Group Type PLACEBO_COMPARATOR

Identical looking placebo capsule

Intervention Type DIETARY_SUPPLEMENT

Identical looking placebo twice per day for 10 weeks

Interventions

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Artemisinin

100 mg of artemisinin twice per day for 10 weeks

Intervention Type DIETARY_SUPPLEMENT

Identical looking placebo capsule

Identical looking placebo twice per day for 10 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No