Artemisinin to Reduce The Symptoms of Schizophrenia

NCT00753506 | Completed Results DMC

• 1 other identifier: SMRI/SPHS: 2007-02
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia; Schizoaffective Disorder

Outcome Measures

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

  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)

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.

  10 weeks (weeks 2 & 12)

Study Arms (2)

Artemisinin

ACTIVE COMPARATOR

100 mg artemisinin capsule

Dietary Supplement: Artemisinin

Placebo

PLACEBO COMPARATOR

Identical looking placebo capsule

Dietary Supplement: Identical looking placebo capsule

Interventions

Artemisinin DIETARY_SUPPLEMENT

100 mg of artemisinin twice per day for 10 weeks

Artemisinin

Identical looking placebo capsule DIETARY_SUPPLEMENT

Identical looking placebo twice per day for 10 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sheppard Pratt Health System: lead
• Stanley Medical Research Institute: collaborator

Study Sites (1)

Sheppard Pratt Health System

Towson, Maryland, 21204, United States

Location

Related 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.

  PMID: 21546216 RESULT

MeSH Terms

Conditions

Schizophrenia; Psychotic Disorders

Interventions

artemisinin

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Faith Dickerson
• Organization: Sheppard Pratt

fdickerson@sheppardpratt.org

410-938-4359

Study Officials

• Faith B Dickerson, PhD, MPH

  Stanley Research Program at Sheppard Pratt

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Stanley Research Program

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 16, 2008
• Study Start: August 1, 2008
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 28, 2012
• Results First Posted: February 20, 2012

Record last verified: 2012-02

Locations

US (1)