Artemisinin to Reduce The Symptoms of Schizophrenia

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00753506
• Other study ID #: SMRI/SPHS: 2007-02
• Status: Completed
• Phase: N/A
• First received: September 15, 2008
• Last updated: February 27, 2012
• Start date: August 2008
• Est. completion date: May 2010

Study information

• Verified date: February 2012
• Source: Sheppard Pratt Health System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychotic Disorders
• Schizoaffective Disorder
• Schizophrenia

Intervention

Dietary Supplement:
• Artemisinin
100 mg of artemisinin twice per day for 10 weeks
• Identical looking placebo capsule
Identical looking placebo twice per day for 10 weeks

Locations

Country	Name	City	State
United States	Sheppard Pratt Health System	Towson	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sheppard Pratt Health System	Stanley Medical Research Institute

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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	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.	10 weeks (weeks 2 & 12)	No
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.		10 weeks (weeks 2 & 12)	No