Artemisinin to Reduce The Symptoms of Schizophrenia

This study has been completed.
Sponsor:
Collaborator:
Stanley Medical Research Institute
Information provided by (Responsible Party):
Faith Dickerson, PhD, MPH, Sheppard Pratt Health System
ClinicalTrials.gov Identifier:
NCT00753506
First received: September 15, 2008
Last updated: February 27, 2012
Last verified: February 2012
  Purpose

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.


Condition Intervention
Schizophrenia
Schizoaffective Disorder
Dietary Supplement: Artemisinin
Dietary Supplement: Identical looking placebo capsule

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-Blind Trial of Artemisinin to Reduce The Symptoms of Schizophrenia

Resource links provided by NLM:


Further study details as provided by Sheppard Pratt Health System:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 66
Study Start Date: August 2008
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Artemisinin
100 mg artemisinin capsule
Dietary Supplement: Artemisinin
100 mg of artemisinin twice per day for 10 weeks
Placebo Comparator: Placebo
Identical looking placebo capsule
Dietary Supplement: Identical looking placebo capsule
Identical looking placebo twice per day for 10 weeks

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

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00753506

Locations
United States, Maryland
Sheppard Pratt Health System
Towson, Maryland, United States, 21204
Sponsors and Collaborators
Sheppard Pratt Health System
Stanley Medical Research Institute
Investigators
Principal Investigator: Faith B Dickerson, PhD, MPH Stanley Research Program at Sheppard Pratt
  More Information

Publications:
Responsible Party: Faith Dickerson, PhD, MPH, Head, Stanley Research Program, Sheppard Pratt Health System
ClinicalTrials.gov Identifier: NCT00753506     History of Changes
Other Study ID Numbers: SMRI/SPHS: 2007-02
Study First Received: September 15, 2008
Results First Received: August 22, 2011
Last Updated: February 27, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Psychotic Disorders
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Artemisinins
Artemisinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014