CompletedNCT00753506Updated Feb 28, 2012Results posted

Artemisinin to Reduce The Symptoms of Schizophrenia

An interventional study of Artemisinin and Identical looking placebo capsule in Schizophrenia and Schizoaffective Disorder, sponsored by Sheppard Pratt Health System. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2012-02-28.

Sponsored by Sheppard Pratt Health System · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 66
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study 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.

Read the detailed description

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.

Conditions studied

Schizophrenia
Schizoaffective Disorder

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In context

Schizophrenia

3,471 studies on the registry are indexed under Schizophrenia; 472 are open to participants now.

This study's enrollment of 66 is close to the median of 70 across 2,872 interventional studies indexed under Schizophrenia.

Browse Schizophrenia studies →

Lead sponsor

Sheppard Pratt Health System is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

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

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

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 66 participants (actual)

Study arms

Active comparator
Artemisinin
100 mg artemisinin capsule
Dietary Supplement: Artemisinin
Placebo comparator
Placebo
Identical looking placebo capsule
Dietary Supplement: Identical looking placebo capsule

Interventions

Dietary supplementArtemisinin
100 mg of artemisinin twice per day for 10 weeks
Dietary supplementIdentical looking placebo capsule
Identical looking placebo twice per day for 10 weeks

What researchers measure

Primary outcomes

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.
Time frame: 10 weeks (weeks 2 & 12)

Secondary outcomes

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)

Results

Posted Feb 20, 2012

Participant flow

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.

Participant flow — Overall Study
Milestone	Artemisinin	Placebo
Started	33	33
Completed	26	31
Not completed	7	2
Withdrew: Withdrawal by subject	4	1
Withdrew: Lost to follow-up	2	0
Withdrew: Other reason	1	1

Outcome measures

PrimaryChange 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.

Time frame:: 10 weeks (weeks 2 & 12)
Reported as:: Mean · units on a scale

Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
units on a scale	Artemisinin	Placebo
Week 2 PANSS total symptom score	64 ± 8.74	68.13 ± 9.07
Week 12 PANSS total symptom score	61.42 ± 10.53	66.32 ± 9.45
Week 2 PANSS positive score	15.42 ± 4.18	16.26 ± 3.96
Week 12 PANSS positive score	14.92 ± 5.11	16.35 ± 5.35
Week 2 PANSS negative score	19.08 ± 3.12	19.77 ± 3.48
Week 12 PANSS negative score	18.69 ± 3.69	19.03 ± 3.67
Week 2 PANSS general score	29.5 ± 5.32	32.10 ± 6.18
Week 12 PANSS general score	27.81 ± 4.78	30.94 ± 4.84

Statistical analysis

Artemisinin vs Placebo · ANOVA · p = >0.10 · F: 1.59

SecondaryChange 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)

Results for this outcome have not been posted.

Adverse events

Collected over 8/08-1/10. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Artemisinin	—	3/33 (9.1%)	0/26 (0%)
Placebo	—	3/33 (9.1%)	0/31 (0%)

Most frequent serious events

Most frequent serious events
Event	Artemisinin	Placebo
Schizophrenia exacerbationPsychiatric disorders	2/33	2/33
Arm fracture requiring hospitalizationMusculoskeletal and connective tissue disorders	0/33	1/33
Atypical chest painCardiac disorders	1/33	0/33

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Artemisinin	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	33	33	66
>=65 years	0	0	0

Age Continuous
Age Continuous(years)	Artemisinin	Placebo	Total
Mean	45.4 ± 9.0	49.2 ± 9.2	47.3 ± 9.3

Sex: Female, Male
Sex: Female, Male(Participants)	Artemisinin	Placebo	Total
Female	13	15	28
Male	20	18	38

Region of Enrollment
Region of Enrollment(participants)	Artemisinin	Placebo	Total
United States	33	33	66

Study locations

1 site

Sheppard Pratt Health System
Towson, Maryland 21204, United States

References and documents

Publications

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. PubMed 21546216 ↗

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 28, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00753506
Lead sponsor: Sheppard Pratt Health System
Collaborators: Stanley Medical Research Institute
Responsible party: Faith Dickerson, PhD, MPH (Head, Stanley Research Program, Sheppard Pratt Health System) — Principal investigator
First posted: Sep 16, 2008
Start date: Aug 2008
Primary completion: May 2010
Completion: May 2010
Results posted: Feb 20, 2012
Last update: Feb 28, 2012

Study contacts

Faith B Dickerson, PhD, MPH

principal investigator · Stanley Research Program at Sheppard Pratt

Oversight

Data monitoring committee: Yes

View the source record on ClinicalTrials.gov ↗

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