Trial Outcomes & Findings for Anti-Inflammatory Treatment of Schizophrenia (NCT NCT01514682)
NCT ID: NCT01514682
Last Updated: 2022-03-03
Results Overview
The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
The BPRS will be administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.
Results posted on
2022-03-03
Participant Flow
Signed a consent form: 52 (50 unique subjects: 2 withdrew then later re-enrolled, not counted in analysis); Ineligible prior to Evaluation Phase: 1 subject (1=clinically unstable); Entered Evaluation Phase: 49 subjects; Withdrawn prior to randomization: 10 (8=Did not meet BPRS criteria; 1=Did not meet age criteria; 1=On an excluded medication)
Participant milestones
| Measure |
Anti-inflammatory Combination Therapy
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
Placebo
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
20
|
|
Overall Study
COMPLETED
|
13
|
14
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
| Measure |
Anti-inflammatory Combination Therapy
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
Placebo
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Physician Decision
|
4
|
3
|
Baseline Characteristics
Anti-Inflammatory Treatment of Schizophrenia
Baseline characteristics by cohort
| Measure |
Anti-inflammatory Combination Therapy
n=19 Participants
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
Placebo
n=20 Participants
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
12 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
14 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
19 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=93 Participants
|
20 participants
n=4 Participants
|
39 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: The BPRS will be administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.Population: Participants completing the BPRS assessment rating.
The Brief Psychiatric Rating Scale (BPRS) positive symptom items are: conceptual disorganization, hallucinatory behavior, unusual thought content, and suspiciousness. The total score is calculated by adding the scores for each item. Each scale ranges from "1=Not Present" to "7=Very Severe". The minimum score is 4 and the maximum score is 28. A higher score indicates a more severe positive symptom rating.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
Anti-inflammatory Combination Therapy
n=18 Participants
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
|---|---|---|
|
Change in Persistent Positive Symptoms
Baseline Week 0
|
13 units on a scale
Interval 12.0 to 16.0
|
14 units on a scale
Interval 12.0 to 15.0
|
|
Change in Persistent Positive Symptoms
Treatment Week 2
|
14 units on a scale
Interval 11.0 to 16.0
|
14 units on a scale
Interval 11.0 to 18.0
|
|
Change in Persistent Positive Symptoms
Treatment Week 4
|
14 units on a scale
Interval 10.0 to 16.0
|
15 units on a scale
Interval 11.0 to 16.0
|
|
Change in Persistent Positive Symptoms
Treatment Week 6
|
14 units on a scale
Interval 11.0 to 16.0
|
14 units on a scale
Interval 12.0 to 15.0
|
|
Change in Persistent Positive Symptoms
Treatment Week 8
|
12 units on a scale
Interval 10.0 to 16.0
|
14 units on a scale
Interval 10.0 to 17.0
|
|
Change in Persistent Positive Symptoms
Treatment Week 10
|
14 units on a scale
Interval 10.0 to 15.0
|
14 units on a scale
Interval 10.0 to 16.0
|
|
Change in Persistent Positive Symptoms
Treatment Week 12
|
14 units on a scale
Interval 10.0 to 15.0
|
12 units on a scale
Interval 10.0 to 14.0
|
PRIMARY outcome
Timeframe: The MCCB was administered at baseline and end-of-study (Week 12).Population: Participants completing the MCCB testing.
The MATRICS Consensus Cognitive Battery (MCCB) composite score by week ranging from -10-100 with a higher score indicating a better outcome.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
Anti-inflammatory Combination Therapy
n=19 Participants
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
|---|---|---|
|
Change in Neuropsychological Test Performance
Baseline Week 0
|
25 units on a scale
Interval 18.5 to 35.0
|
36 units on a scale
Interval 24.0 to 48.5
|
|
Change in Neuropsychological Test Performance
Treatment Week 12
|
24 units on a scale
Interval 20.0 to 29.2
|
26 units on a scale
Interval 13.8 to 41.2
|
SECONDARY outcome
Timeframe: The CDS was administered at baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.Population: Participants completing the CDS assessment rating.
The Calgary Depression Scale (CDS) total score will be used to measure depressive symptoms. Total score calculated by adding scores for scales #1-#9. Each scale ranges from "0=Absent" to "3=Severe". The minimum total CDS score is 0 and the maximum total CDS score is 27. A higher score indicates a more severe depression rating.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
Anti-inflammatory Combination Therapy
n=19 Participants
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
|---|---|---|
|
Change in Depressive Symptoms
Baseline Week 0
|
2 units on a scale
Interval 0.5 to 3.5
|
0 units on a scale
Interval 0.0 to 2.0
|
|
Change in Depressive Symptoms
Treatment Week 2
|
2 units on a scale
Interval 0.0 to 4.0
|
1 units on a scale
Interval 0.75 to 2.0
|
|
Change in Depressive Symptoms
Treatment Week 4
|
1 units on a scale
Interval 0.25 to 3.0
|
1 units on a scale
Interval 0.0 to 2.5
|
|
Change in Depressive Symptoms
Treatment Week 6
|
2 units on a scale
Interval 1.0 to 3.0
|
1 units on a scale
Interval 0.0 to 3.0
|
|
Change in Depressive Symptoms
Treatment Week 8
|
2 units on a scale
Interval 1.0 to 2.0
|
1 units on a scale
Interval 0.0 to 1.0
|
|
Change in Depressive Symptoms
Treatment Week 10
|
2 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 1.0
|
|
Change in Depressive Symptoms
Treatment Week 12
|
1 units on a scale
Interval 0.0 to 2.0
|
0 units on a scale
Interval 0.0 to 1.8
|
SECONDARY outcome
Timeframe: Baseline and every two weeks throughout the double-blind phase of the study, for up to 12 weeks.Population: Participants completing the SANS rating assessment.
The Scale for the Assessment of Negative Symptoms (SANS) total score, minus the global items, inappropriate affect, poverty of content of speech, and attention items, used to measure negative symptoms. Median SANS total score by treatment and week. SANS total score range = 0-85. Higher scores indicate more severe negative symptoms.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
Anti-inflammatory Combination Therapy
n=19 Participants
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
|---|---|---|
|
Change in Negative Symptoms
Baseline Week 0
|
27 units on a scale
Interval 24.0 to 30.0
|
26 units on a scale
Interval 19.0 to 34.0
|
|
Change in Negative Symptoms
Treatment Week 2
|
28 units on a scale
Interval 23.0 to 33.0
|
24 units on a scale
Interval 20.0 to 30.0
|
|
Change in Negative Symptoms
Treatment Week 4
|
32 units on a scale
Interval 25.0 to 34.0
|
30 units on a scale
Interval 20.0 to 34.0
|
|
Change in Negative Symptoms
Treatment Week 6
|
28 units on a scale
Interval 21.0 to 34.0
|
27 units on a scale
Interval 23.0 to 30.0
|
|
Change in Negative Symptoms
Treatment Week 8
|
30 units on a scale
Interval 25.0 to 36.0
|
24 units on a scale
Interval 19.0 to 34.0
|
|
Change in Negative Symptoms
Treatment Week 10
|
30 units on a scale
Interval 24.0 to 33.0
|
30 units on a scale
Interval 17.0 to 32.0
|
|
Change in Negative Symptoms
Treatment Week 12
|
28 units on a scale
Interval 22.0 to 34.0
|
28 units on a scale
Interval 19.0 to 32.0
|
SECONDARY outcome
Timeframe: A cytokine profile will be collected at baseline and at week 12 (end-of-study).Population: Participants who had a cytokine profile collected.
Data was only available on 2 of the 9 cytokines (i.e., IL-2 and IL-8) and C-Reactive Protein (CRP). The baseline values for the other cytokines in the panel were below the level of detection.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
Anti-inflammatory Combination Therapy
n=19 Participants
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
|---|---|---|
|
Change in Pro-inflammatory Cytokines
Baseline IL-2 levels
|
59.16 pg/ml
Standard Deviation 88.38
|
34.94 pg/ml
Standard Deviation 77.01
|
|
Change in Pro-inflammatory Cytokines
End of study IL-2 levels
|
88.4 pg/ml
Standard Deviation 146.0
|
47.5 pg/ml
Standard Deviation 86.0
|
|
Change in Pro-inflammatory Cytokines
Baseline IL-8 levels
|
9.16 pg/ml
Standard Deviation 5.59
|
8.35 pg/ml
Standard Deviation 4.59
|
|
Change in Pro-inflammatory Cytokines
End of study IL-8 levels
|
8.91 pg/ml
Standard Deviation 7.24
|
19.78 pg/ml
Standard Deviation 46.91
|
SECONDARY outcome
Timeframe: A cytokine profile will be collected at baseline and at week 12 (end-of-study).Population: Participants who had a cytokine profile collected.
Data was only available on 2 of the 9 cytokines (i.e., IL-2 and IL-8) and C-Reactive Protein (CRP). The baseline values for the other cytokines in the panel were below the level of detection.
Outcome measures
| Measure |
Placebo
n=19 Participants
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
Anti-inflammatory Combination Therapy
n=19 Participants
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
|---|---|---|
|
Change in C-Reactive Protein (CRP)
Baseline CRP levels
|
38953 ng/ml
Standard Deviation 27218
|
42950 ng/ml
Standard Deviation 32468
|
|
Change in C-Reactive Protein (CRP)
End of study CRP levels
|
38759 ng/ml
Standard Deviation 21753
|
31849 ng/ml
Standard Deviation 23176
|
Adverse Events
Placebo
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Anti-inflammatory Combination Therapy
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
Anti-inflammatory Combination Therapy
n=19 participants at risk
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
|---|---|---|
|
General disorders
Hospitalization
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Psychiatric disorders
Hospitalization
|
5.0%
1/20 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
0.00%
0/19 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
Other adverse events
| Measure |
Placebo
n=20 participants at risk
Placebo pills to be assigned using a permuted randomization system
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
Placebo: Non-medication pills; To be taken in morning and evening intervals.
|
Anti-inflammatory Combination Therapy
n=19 participants at risk
Salsalate, statin and omega-3-fatty acid combination therapy
Anti-inflammatory Combination Therapy: a. salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening b. fluvastatin: target dose 40 mg/day, administered in a single evening dose c. combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose
|
|---|---|---|
|
Gastrointestinal disorders
Eructation
|
10.0%
2/20 • Number of events 2 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
0.00%
0/19 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
General disorders
Abdominal pain
|
5.0%
1/20 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
0.00%
0/19 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Psychiatric disorders
Psychiatric symptom increase
|
20.0%
4/20 • Number of events 6 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
21.1%
4/19 • Number of events 8 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
1/20 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
0.00%
0/19 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Blood and lymphatic system disorders
High triglyceride levels
|
5.0%
1/20 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
0.00%
0/19 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Cardiac disorders
Abnormal EKG
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
General disorders
Hypersalivation
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
15.8%
3/19 • Number of events 3 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
2/20 • Number of events 2 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Renal and urinary disorders
Enuresis
|
5.0%
1/20 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
0.00%
0/19 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Gastrointestinal disorders
Nausea
|
5.0%
1/20 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
0.00%
0/19 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
15.8%
3/19 • Number of events 4 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
General disorders
Fever
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
10.5%
2/19 • Number of events 2 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Gastrointestinal disorders
Upset stomach
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
General disorders
Memory loss
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Vascular disorders
Hypertension
|
5.0%
1/20 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
0.00%
0/19 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Musculoskeletal and connective tissue disorders
Myoclonus
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
General disorders
Dysgeusia
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
10.5%
2/19 • Number of events 2 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.0%
1/20 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.0%
1/20 • Number of events 2 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
General disorders
Gait instability
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnea
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
10.5%
2/19 • Number of events 2 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Musculoskeletal and connective tissue disorders
Stiffness
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
10.5%
2/19 • Number of events 2 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Renal and urinary disorders
Dark urine
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
General disorders
Insomnia
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Nervous system disorders
Generalized pain
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
|
General disorders
Dry mouth
|
0.00%
0/20 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
|
5.3%
1/19 • Number of events 1 • 12-week Treatment Phase.
Participants are systematically monitored for any increases on the Side Effects Checklist (SEC). An SEC AE includes any symptom/side effect rated with a score of 4 (severe) or for which there was a 2 point change in severity from baseline. Psychotic symptoms are also systematically monitored with the Brief Psychiatric Rating Scale (BPRS) rating. A BPRS AE includes an increase of 3 points or more relative to baseline or an increase from a score of 5 (moderately severe) to a 7 (very severe).
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Additional Information
Robert W. Buchanan, M.D.
Maryland Psychiatric Research Center
Phone: 410-402-7876
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place