Trial Outcomes & Findings for Artemisinin to Reduce The Symptoms of Schizophrenia (NCT NCT00753506)
NCT ID: NCT00753506
Last Updated: 2012-02-28
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
10 weeks (weeks 2 & 12)
Results posted on
2012-02-28
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.
We used a two week placebo run in for all participants
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
26
|
31
|
|
Overall Study
NOT COMPLETED
|
7
|
2
|
Reasons for withdrawal
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Other reason
|
1
|
1
|
Baseline Characteristics
Artemisinin to Reduce The Symptoms of Schizophrenia
Baseline characteristics by cohort
| Measure |
Artemisinin
n=33 Participants
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).
|
Placebo
n=33 Participants
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.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
45.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
49.2 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
47.3 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
33 participants
n=5 Participants
|
33 participants
n=7 Participants
|
66 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 10 weeks (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.
Outcome measures
| Measure |
Artemisinin
n=26 Participants
100 mg capsule of artemisinin taken twice per day.
|
Placebo
n=31 Participants
100 mg artemisinin identical placebo capsule taken twice per day.
|
|---|---|---|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
Week 2 PANSS total symptom score
|
64 units on a scale
Standard Deviation 8.74
|
68.13 units on a scale
Standard Deviation 9.07
|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
Week 12 PANSS total symptom score
|
61.42 units on a scale
Standard Deviation 10.53
|
66.32 units on a scale
Standard Deviation 9.45
|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
Week 2 PANSS positive score
|
15.42 units on a scale
Standard Deviation 4.18
|
16.26 units on a scale
Standard Deviation 3.96
|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
Week 12 PANSS positive score
|
14.92 units on a scale
Standard Deviation 5.11
|
16.35 units on a scale
Standard Deviation 5.35
|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
Week 2 PANSS negative score
|
19.08 units on a scale
Standard Deviation 3.12
|
19.77 units on a scale
Standard Deviation 3.48
|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
Week 12 PANSS negative score
|
18.69 units on a scale
Standard Deviation 3.69
|
19.03 units on a scale
Standard Deviation 3.67
|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
Week 2 PANSS general score
|
29.5 units on a scale
Standard Deviation 5.32
|
32.10 units on a scale
Standard Deviation 6.18
|
|
Change in Positive and Negative Syndrome Scale (PANSS) Score From the Beginning to the End of the Double-blind Treatment Phase Weeks 2-12
Week 12 PANSS general score
|
27.81 units on a scale
Standard Deviation 4.78
|
30.94 units on a scale
Standard Deviation 4.84
|
SECONDARY outcome
Timeframe: 10 weeks (weeks 2 & 12)Outcome measures
Outcome data not reported
Adverse Events
Artemisinin
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 3 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Artemisinin
n=26 participants at risk；n=33 participants at risk
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).
|
Placebo
n=31 participants at risk；n=33 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arm fracture requiring hospitalization
|
0.00%
0/33 • 8/08-1/10
|
3.0%
1/33 • Number of events 1 • 8/08-1/10
|
|
Cardiac disorders
Atypical chest pain
|
3.0%
1/33 • Number of events 1 • 8/08-1/10
|
0.00%
0/33 • 8/08-1/10
|
|
Psychiatric disorders
Schizophrenia exacerbation
|
6.1%
2/33 • Number of events 2 • 8/08-1/10
|
6.1%
2/33 • Number of events 2 • 8/08-1/10
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place