Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Stanley Medical Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
The aims of the current study are:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artemisinin | Active Comparator | 100 mg artemisinin capsule |
|
| Placebo | Placebo Comparator | Identical looking placebo capsule |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artemisinin | Dietary Supplement | 100 mg of artemisinin twice per day for 10 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Faith B Dickerson, PhD, MPH | Stanley Research Program at Sheppard Pratt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheppard Pratt Health System | Towson | Maryland | 21204 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21546216 | Result | 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. |
Not provided
Not provided
We used a two week placebo run in for all participants
We enrolled n=66 participants drawn from the Sheppard Pratt Health System and from rehabilitation and treatment programs in Central Maryland. Dates of recruitment 8/08-1/10.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Artemisinin | Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006). |
| FG001 | Placebo | Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Artemisinin | Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 10 weeks (weeks 2 & 12) |
|
8/08-1/10
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Artemisinin | Artemisinin 100 mg capsule Artemisinin (qinghaosu) is the antimalarial principle isolated by Chinese scientists from Artemisia annua L. (Sweet Wormwood plant), which has been in use in China for more than 2,000 years as an herbal tea against fever (van Agtmael et al., 1999). Artemisinin is a sesquiterpene trioxane lactone with a peroxide bridge linkage and is poorly soluble in oils or water. Johns Hopkins collaborators recently synthesized novel, nonacetal, hydrolytically stable derivatives of artemisinin and showed that they inhibit the replication of Toxoplasma gondii in cell culture (Jones-Brando et al., 2006). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Arm fracture requiring hospitalization | Musculoskeletal and connective tissue disorders | Systematic Assessment |
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Faith Dickerson | Sheppard Pratt | 410-938-4359 | fdickerson@sheppardpratt.org |
Not provided
| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| D011618 | Psychotic Disorders |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| C031327 | artemisinin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Identical looking placebo capsule |
| Dietary Supplement |
Identical looking placebo twice per day for 10 weeks |
|
| Other reason |
|
| BG001 | Placebo | Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Placebo | 100 mg artemisinin identical placebo capsule taken twice per day. |
|
|
|
| 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. | Not Posted | 10 weeks (weeks 2 & 12) |
| 3 |
| 33 |
| 0 |
| 26 |
| EG001 | Placebo | Identical looking placebo capsule The placebo will contain an inert powder which is typically used to make many pharmaceutical tablets. The control capsules will be identical looking to the artemisinin capsules and will be prepared for use in this study by the Temple University Pharmacy which has experience in preparing materials for clinical trials. | 3 | 33 | 0 | 31 |
| Atypical chest pain | Cardiac disorders | Systematic Assessment |
|
| Schizophrenia exacerbation | Psychiatric disorders | Systematic Assessment |
|
Not provided
Not provided