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Completed

NCT Number: NCT00753506

Artemisinin to Reduce The Symptoms of Schizophrenia

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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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sheppard Pratt Health System

Towson, Maryland, 21204, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artemisinin

Dietary Supplement

100 mg of artemisinin twice per day for 10 weeks

Identical looking placebo capsule

Dietary Supplement

Identical looking placebo twice per day for 10 weeks

Primary outcomes

  1. 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

  1. 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)

Sponsors and collaborators

Lead sponsor

Sheppard Pratt Health System

Other

Collaborators

  • Stanley Medical Research Institute

Registry information

Official study title

Double-Blind Trial of Artemisinin to Reduce The Symptoms of Schizophrenia

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 16, 2008
Registry last updated
Feb 28, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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