Trial Outcomes & Findings for A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia (NCT NCT02008773)
NCT ID: NCT02008773
Last Updated: 2019-01-30
Results Overview
To determine the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve visual memory (Brief Visuospatial Memory Test) in individuals who are HSV-1 positive and early in the course of schizophrenia. The Brief Visuospatial Memory Test is a subscale of the MATRICS Consensus Cognitive Battery (MCCB) and was used to assess visual memory. The BVMT consists of three trials in which participants must recall shapes by drawing figures on a blank page after being given the opportunity to memorize the figures for 10 seconds. Each page consists of six figures. Points are awarded based on the accuracy of the drawn figure and by correct placement on the page. A minimum of 0 to 12 points are awarded per trial, so a participant can score between 0 and 36 points for all three trials. The raw score is then converted to a t-score, normed by age and sex. The min and max t-scores are between 0-100, a higher t-score representing a better outcome.
COMPLETED
PHASE2
170 participants
Baseline, 8 weeks, and 16 weeks
2019-01-30
Participant Flow
Participant milestones
| Measure |
HSV1+ Placebo
HSV1 positive subjects assigned to the HSV1+ placebo arm
|
HSV1+ Valacyclovir
HSV1 positive subjects assigned to the Valacyclovir study treatment arm
|
HSV1- Placebo
HSV1 negative subjects assigned to the placebo arm
|
HSV1- Valacyclovir
HSV1 negative subjects assigned to the Valacyclovir study treatment arm
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
34
|
46
|
50
|
|
Overall Study
COMPLETED
|
27
|
25
|
32
|
38
|
|
Overall Study
NOT COMPLETED
|
13
|
9
|
14
|
12
|
Reasons for withdrawal
| Measure |
HSV1+ Placebo
HSV1 positive subjects assigned to the HSV1+ placebo arm
|
HSV1+ Valacyclovir
HSV1 positive subjects assigned to the Valacyclovir study treatment arm
|
HSV1- Placebo
HSV1 negative subjects assigned to the placebo arm
|
HSV1- Valacyclovir
HSV1 negative subjects assigned to the Valacyclovir study treatment arm
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
3
|
1
|
2
|
|
Overall Study
Medication Non-compliance
|
2
|
1
|
3
|
2
|
|
Overall Study
Withdrawal by Subject
|
8
|
4
|
7
|
6
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
3
|
2
|
Baseline Characteristics
A Double-Blind Trial of Adjunctive Valacyclovir to Improve Cognition in Early Phase Schizophrenia
Baseline characteristics by cohort
| Measure |
HSV1+ Placebo
n=40 Participants
HSV1 positive subjects assigned to the HSV1+ placebo arm
|
HSV1+ Valacyclovir
n=34 Participants
HSV1 positive subjects assigned to the Valacyclovir study treatment arm
|
HSV1- Placebo
n=46 Participants
HSV1 negative subjects assigned to the placebo arm
|
HSV1- Valacyclovir
n=50 Participants
HSV1 negative subjects assigned to the Valacyclovir study treatment arm
|
Total
n=170 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
40 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
170 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
30 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
29.9 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
25.3 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
27.4 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
28.15 years
STANDARD_DEVIATION 2.25 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
44 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
38 Participants
n=4 Participants
|
126 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
20 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
95 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
41 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
34 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
34 participants
n=7 Participants
|
46 participants
n=5 Participants
|
50 participants
n=4 Participants
|
170 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, 8 weeks, and 16 weeksTo determine the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve visual memory (Brief Visuospatial Memory Test) in individuals who are HSV-1 positive and early in the course of schizophrenia. The Brief Visuospatial Memory Test is a subscale of the MATRICS Consensus Cognitive Battery (MCCB) and was used to assess visual memory. The BVMT consists of three trials in which participants must recall shapes by drawing figures on a blank page after being given the opportunity to memorize the figures for 10 seconds. Each page consists of six figures. Points are awarded based on the accuracy of the drawn figure and by correct placement on the page. A minimum of 0 to 12 points are awarded per trial, so a participant can score between 0 and 36 points for all three trials. The raw score is then converted to a t-score, normed by age and sex. The min and max t-scores are between 0-100, a higher t-score representing a better outcome.
Outcome measures
| Measure |
HSV1+ Valacyclovir
n=34 Participants
HSV1 positive subjects assigned to the Valacyclovir study treatment arm
|
HSV1+ Placebo
n=40 Participants
HSV1 positive subjects assigned to the HSV1+ placebo arm
|
HSV1- Valacyclovir
n=50 Participants
HSV1 negative subjects assigned to the Valacyclovir study treatment arm
|
HSV1- Placebo
n=46 Participants
HSV1 negative subjects assigned to the placebo arm
|
|---|---|---|---|---|
|
Visual Memory
MATRICS Brief Visuospatial Memory Baseline
|
37.1 visual memory scores
Standard Error 2.1
|
33.9 visual memory scores
Standard Error 1.9
|
39.6 visual memory scores
Standard Error 1.7
|
34.2 visual memory scores
Standard Error 1.9
|
|
Visual Memory
MATRICS Brief Visuospatial Memory Week 8
|
38.2 visual memory scores
Standard Error 2.1
|
34.6 visual memory scores
Standard Error 1.9
|
39.4 visual memory scores
Standard Error 1.7
|
38.0 visual memory scores
Standard Error 1.9
|
|
Visual Memory
MATRICS Brief Visuospatial Memory Week 16
|
39.6 visual memory scores
Standard Error 2.1
|
37.3 visual memory scores
Standard Error 1.9
|
42.2 visual memory scores
Standard Error 1.7
|
41.3 visual memory scores
Standard Error 1.9
|
PRIMARY outcome
Timeframe: Baseline, 8 weeks, and 16 weeksDetermine the efficacy of adjunctive valacyclovir, in comparison to placebo, on working memory (composite score of the Wechsler Memory Scale-III: Spatial Span and Letter Number Span tests). WMS has 2 sections in which a subject recalls increasingly difficult sequences. The total raw score range for both sections is 0-32. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. LNS consists of 24 increasingly difficult sequences of letters and numbers that a subject is to recall and repeat back in Numeric-Alpha sequential order. The total raw score range is 0-24. The raw score is then converted to a tscore based on normative ranges by age and sex, ranging from 0-100. For both the raw and tscore a higher score reflects better performance. The Working Memory composite score is calculated by summing the WMS and LNS tscores, a higher tscore reflects better performance.
Outcome measures
| Measure |
HSV1+ Valacyclovir
n=34 Participants
HSV1 positive subjects assigned to the Valacyclovir study treatment arm
|
HSV1+ Placebo
n=40 Participants
HSV1 positive subjects assigned to the HSV1+ placebo arm
|
HSV1- Valacyclovir
n=50 Participants
HSV1 negative subjects assigned to the Valacyclovir study treatment arm
|
HSV1- Placebo
n=46 Participants
HSV1 negative subjects assigned to the placebo arm
|
|---|---|---|---|---|
|
Working Memory
MATRICS Working Memory Scores at Baseline
|
31.8 Working Memory Scores
Standard Error 1.9
|
34.1 Working Memory Scores
Standard Error 1.8
|
40.7 Working Memory Scores
Standard Error 1.6
|
35.5 Working Memory Scores
Standard Error 1.8
|
|
Working Memory
MATRICS Working Memory Scores at 8 weeks
|
34.4 Working Memory Scores
Standard Error 1.9
|
34.7 Working Memory Scores
Standard Error 1.8
|
41.6 Working Memory Scores
Standard Error 1.6
|
39.5 Working Memory Scores
Standard Error 1.8
|
|
Working Memory
MATRICS Working Memory Scores at 16 weeks
|
34.7 Working Memory Scores
Standard Error 1.9
|
36.4 Working Memory Scores
Standard Error 1.8
|
42.6 Working Memory Scores
Standard Error 1.6
|
39.0 Working Memory Scores
Standard Error 1.8
|
SECONDARY outcome
Timeframe: Baseline, 8 Weeks, and 16 weeksTo evaluate the efficacy of adjunctive valacyclovir, in comparison to placebo, to improve general cognitive performance as measured by the MATRICS Consensus Cognitive Battery composite score in HSV1 + and - participants. MCCB is comprised of 10 tests, Trail Making Test Part A; Brief Assessment in Cognition in Schizophrenia Symbol Coding; Hopkins Verbal Learning Test-Revised; Wechsler Memory Scale-III Spatial Span; Letter Number Sequencing; Neuropsychological Assessment Battery Mazes; Brief Visuospatial Memory Test-Revised; Category Fluency Animal Naming; Mayer-Salovey-Caruso Emotional Intelligence Test Managing Emotions; and Continuous Performance Test-Identical Pairs. For each test, a score is derived based on the raw item values. Each of the individual item raw scores is standardized to age and gender corrected tscores which are then summed to convert into a composite score ranging from \<214-\>486 based on the MCCB scoring manual, with a higher score reflecting better performance.
Outcome measures
| Measure |
HSV1+ Valacyclovir
n=34 Participants
HSV1 positive subjects assigned to the Valacyclovir study treatment arm
|
HSV1+ Placebo
n=40 Participants
HSV1 positive subjects assigned to the HSV1+ placebo arm
|
HSV1- Valacyclovir
n=50 Participants
HSV1 negative subjects assigned to the Valacyclovir study treatment arm
|
HSV1- Placebo
n=46 Participants
HSV1 negative subjects assigned to the placebo arm
|
|---|---|---|---|---|
|
Cognitive Performance
MATRICS Overall Composite Score at baseline
|
27.8 MATRICS Composite Scores
Standard Error 2.3
|
29.4 MATRICS Composite Scores
Standard Error 2.1
|
34.8 MATRICS Composite Scores
Standard Error 1.9
|
30.2 MATRICS Composite Scores
Standard Error 2.2
|
|
Cognitive Performance
MATRICS Overall Composite Score at 8 weeks
|
27.8 MATRICS Composite Scores
Standard Error 2.3
|
30.0 MATRICS Composite Scores
Standard Error 2.1
|
35.6 MATRICS Composite Scores
Standard Error 1.9
|
33.3 MATRICS Composite Scores
Standard Error 2.2
|
|
Cognitive Performance
MATRICS Overall Composite Score at 16 weeks
|
29.6 MATRICS Composite Scores
Standard Error 32.6
|
32.6 MATRICS Composite Scores
Standard Error 2.1
|
39.2 MATRICS Composite Scores
Standard Error 1.9
|
36.4 MATRICS Composite Scores
Standard Error 2.2
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, and 16 weeksTo evaluate the efficacy of adj. valacyclovir to improve functional performance and quality of life (QOL) as measured by the UCSD Performance-Based Skills Assessment, Version B (UPSA-B); QOL Enjoyment and Satisfaction Questionnaire Short Form (Q-LES); and Personal and Social Performance Scale (PSP). The UPSA-B is a performance-based assessment of improvement in functional capacity.Participants are asked to role-play communication and finance tasks. Scores are assigned for each of the 2 subscales and formula is used to calculate a total score (0-100). A higher score reflects better performance. The Q-LES, 16 item scale yields a raw total score, ranging from 14-70, with a higher score representing higher QOL. The PSP scale is a single item scale assessing 4 domains of functioning: personal\&social relationships, socially useful activities, self-care, and disturbing\&aggressive behaviors. An adjusted score from 0-100 is generated, a higher score reflects better functioning.
Outcome measures
| Measure |
HSV1+ Valacyclovir
n=34 Participants
HSV1 positive subjects assigned to the Valacyclovir study treatment arm
|
HSV1+ Placebo
n=40 Participants
HSV1 positive subjects assigned to the HSV1+ placebo arm
|
HSV1- Valacyclovir
n=50 Participants
HSV1 negative subjects assigned to the Valacyclovir study treatment arm
|
HSV1- Placebo
n=46 Participants
HSV1 negative subjects assigned to the placebo arm
|
|---|---|---|---|---|
|
Functional Performance
Q-LES-Q-SF Total Score at 8 weeks
|
50.9 Scores on a Scale
Standard Error 1.6
|
51.4 Scores on a Scale
Standard Error 1.5
|
52.6 Scores on a Scale
Standard Error 1.3
|
50.7 Scores on a Scale
Standard Error 1.5
|
|
Functional Performance
Q-LES-Q-SF Total Score at 16 weeks
|
49.3 Scores on a Scale
Standard Error 1.6
|
53.7 Scores on a Scale
Standard Error 1.5
|
54.0 Scores on a Scale
Standard Error 1.3
|
52.7 Scores on a Scale
Standard Error 1.5
|
|
Functional Performance
UPSA-B Total Score at Baseline
|
72.6 Scores on a Scale
Standard Error 2.5
|
71.8 Scores on a Scale
Standard Error 2.4
|
71.9 Scores on a Scale
Standard Error 2.2
|
73.4 Scores on a Scale
Standard Error 2.4
|
|
Functional Performance
UPSA-B Total Score at 8 weeks
|
73.4 Scores on a Scale
Standard Error 2.5
|
74.5 Scores on a Scale
Standard Error 2.4
|
75.3 Scores on a Scale
Standard Error 2.2
|
78.6 Scores on a Scale
Standard Error 2.4
|
|
Functional Performance
UPSA-B Total Score at 16 weeks
|
76.7 Scores on a Scale
Standard Error 2.5
|
75.6 Scores on a Scale
Standard Error 2.4
|
77.5 Scores on a Scale
Standard Error 2.2
|
78.8 Scores on a Scale
Standard Error 2.4
|
|
Functional Performance
Q-LES-Q-SF Total Score at Baseline
|
47.8 Scores on a Scale
Standard Error 1.6
|
50.8 Scores on a Scale
Standard Error 1.5
|
53.0 Scores on a Scale
Standard Error 1.3
|
49.4 Scores on a Scale
Standard Error 1.5
|
|
Functional Performance
PSP Adjusted Score at Baseline
|
55.4 Scores on a Scale
Standard Error 2.1
|
58.2 Scores on a Scale
Standard Error 2.0
|
59.9 Scores on a Scale
Standard Error 1.8
|
59.2 Scores on a Scale
Standard Error 2.0
|
|
Functional Performance
PSP Adjusted Score at 8 weeks
|
55.6 Scores on a Scale
Standard Error 2.1
|
60.5 Scores on a Scale
Standard Error 2.0
|
61.7 Scores on a Scale
Standard Error 1.8
|
61.4 Scores on a Scale
Standard Error 2.0
|
|
Functional Performance
PSP Adjusted Score at 16 weeks
|
58.3 Scores on a Scale
Standard Error 2.1
|
60.8 Scores on a Scale
Standard Error 2.0
|
61.3 Scores on a Scale
Standard Error 1.8
|
61.5 Scores on a Scale
Standard Error 2.0
|
SECONDARY outcome
Timeframe: Baseline, 4 weeks, 8 weeks, 12 weeks, and 16 weeksTo evaluate the efficacy of adj. valacyclovir for general and positive symptoms (sxs) as measured by the PANSS total and factor scores and negative sxs as measured by the NSA-16.The PANSS contains 30 items that assess sxs of psychotic d/os.Positive sxs are rated on 7 items, negative sxs on 7 items, and general psych. on 16 items.Scores for each item range from 1-7.Positive total scores ranging from 7-49, negative total scores ranging from 7-49, and general psych. scores ranging from 16-112.Total scores for all items range from 30-210.Additionally a factor score can be derived for Cognition/Disorganization by using scores from 7 items and ranges from 7-49.For factor and total scores a lower score reflects fewer sxs.The NSA-16 is used to rate behaviors commonly associated with negative sxs of schizophrenia.The scale rates subjects on 16 anchors from 1 to 6.The total score is the sum of the 16 specific items and ranges from 16 to 96; a higher score indicates greater severity of illness.
Outcome measures
| Measure |
HSV1+ Valacyclovir
n=34 Participants
HSV1 positive subjects assigned to the Valacyclovir study treatment arm
|
HSV1+ Placebo
n=40 Participants
HSV1 positive subjects assigned to the HSV1+ placebo arm
|
HSV1- Valacyclovir
n=50 Participants
HSV1 negative subjects assigned to the Valacyclovir study treatment arm
|
HSV1- Placebo
n=46 Participants
HSV1 negative subjects assigned to the placebo arm
|
|---|---|---|---|---|
|
Psychosis Symptoms
PANSS Total Score at Baseline
|
66.4 Symptom Scale Scores
Standard Error 2.7
|
61.1 Symptom Scale Scores
Standard Error 2.5
|
58.9 Symptom Scale Scores
Standard Error 2.3
|
64.2 Symptom Scale Scores
Standard Error 2.6
|
|
Psychosis Symptoms
PANSS Total Score at 4 weeks
|
64.8 Symptom Scale Scores
Standard Error 2.7
|
60.5 Symptom Scale Scores
Standard Error 2.5
|
58.0 Symptom Scale Scores
Standard Error 2.3
|
62.1 Symptom Scale Scores
Standard Error 2.6
|
|
Psychosis Symptoms
PANSS Total Score at 8 weeks
|
64.0 Symptom Scale Scores
Standard Error 2.7
|
59.5 Symptom Scale Scores
Standard Error 2.5
|
57.3 Symptom Scale Scores
Standard Error 2.3
|
63.5 Symptom Scale Scores
Standard Error 2.6
|
|
Psychosis Symptoms
PANSS Total Score at 12 weeks
|
62.6 Symptom Scale Scores
Standard Error 2.7
|
59.3 Symptom Scale Scores
Standard Error 2.5
|
56.0 Symptom Scale Scores
Standard Error 2.3
|
61.1 Symptom Scale Scores
Standard Error 2.6
|
|
Psychosis Symptoms
PANSS Total Score at 16 weeks
|
65.1 Symptom Scale Scores
Standard Error 2.7
|
57.9 Symptom Scale Scores
Standard Error 2.5
|
56.0 Symptom Scale Scores
Standard Error 2.3
|
58.9 Symptom Scale Scores
Standard Error 2.6
|
|
Psychosis Symptoms
PANSS Positive Symptom Factor Score at Baseline
|
20.5 Symptom Scale Scores
Standard Error 1.0
|
19.3 Symptom Scale Scores
Standard Error 10
|
17.2 Symptom Scale Scores
Standard Error 0.9
|
19.3 Symptom Scale Scores
Standard Error 1.0
|
|
Psychosis Symptoms
PANSS Positive Symptom Factor Score at 4 weeks
|
20.7 Symptom Scale Scores
Standard Error 1.0
|
18.8 Symptom Scale Scores
Standard Error 1.0
|
17.1 Symptom Scale Scores
Standard Error 0.9
|
18.7 Symptom Scale Scores
Standard Error 1.0
|
|
Psychosis Symptoms
PANSS Positive Symptom Factor Score at 8 weeks
|
20.1 Symptom Scale Scores
Standard Error 1.0
|
18.4 Symptom Scale Scores
Standard Error 1.0
|
16.8 Symptom Scale Scores
Standard Error 0.9
|
18.7 Symptom Scale Scores
Standard Error 1.0
|
|
Psychosis Symptoms
PANSS Positive Symptom Factor Score at 12 weeks
|
19.2 Symptom Scale Scores
Standard Error 1.0
|
18.0 Symptom Scale Scores
Standard Error 1.0
|
16.0 Symptom Scale Scores
Standard Error 0.9
|
18.3 Symptom Scale Scores
Standard Error 1.0
|
|
Psychosis Symptoms
PANSS Positive Symptom Factor Score at 16 weeks
|
19.1 Symptom Scale Scores
Standard Error 1.0
|
17.1 Symptom Scale Scores
Standard Error 1.0
|
16.1 Symptom Scale Scores
Standard Error 0.9
|
17.2 Symptom Scale Scores
Standard Error 1.0
|
|
Psychosis Symptoms
PANSS Negative Symptom Factor Score at Baseline
|
17.1 Symptom Scale Scores
Standard Error 1.1
|
14.2 Symptom Scale Scores
Standard Error 1.0
|
15.6 Symptom Scale Scores
Standard Error 0.9
|
16.0 Symptom Scale Scores
Standard Error 1.0
|
|
Psychosis Symptoms
PANSS Negative Symptom Factor Score at 4 weeks
|
16.8 Symptom Scale Scores
Standard Error 1.1
|
15.0 Symptom Scale Scores
Standard Error 1.0
|
15.4 Symptom Scale Scores
Standard Error 0.9
|
15.5 Symptom Scale Scores
Standard Error 1.0
|
|
Psychosis Symptoms
PANSS Negative Symptom Factor Score at 8 weeks
|
16.5 Symptom Scale Scores
Standard Error 1.1
|
15.3 Symptom Scale Scores
Standard Error 1.0
|
14.9 Symptom Scale Scores
Standard Error 0.9
|
16.0 Symptom Scale Scores
Standard Error 1.0
|
|
Psychosis Symptoms
PANSS Negative Symptom Factor Score at 12 weeks
|
16.6 Symptom Scale Scores
Standard Error 1.1
|
14.7 Symptom Scale Scores
Standard Error 1.0
|
14.7 Symptom Scale Scores
Standard Error 1.0
|
16.0 Symptom Scale Scores
Standard Error 1.0
|
|
Psychosis Symptoms
PANSS Negative Symptom Factor Score at 16 weeks
|
17.5 Symptom Scale Scores
Standard Error 1.1
|
14.8 Symptom Scale Scores
Standard Error 1.0
|
14.8 Symptom Scale Scores
Standard Error 1.0
|
14.8 Symptom Scale Scores
Standard Error 1.0
|
|
Psychosis Symptoms
PANSS Cognitive/Disorganized Factor Score at Base
|
13.7 Symptom Scale Scores
Standard Error 0.7
|
13.5 Symptom Scale Scores
Standard Error 0.6
|
12.5 Symptom Scale Scores
Standard Error 0.6
|
13.2 Symptom Scale Scores
Standard Error 0.6
|
|
Psychosis Symptoms
PANSS Cognitive/Disorganized Factor Score at 4 wks
|
14.0 Symptom Scale Scores
Standard Error 0.7
|
12.7 Symptom Scale Scores
Standard Error 0.6
|
12.3 Symptom Scale Scores
Standard Error 0.6
|
13.0 Symptom Scale Scores
Standard Error 0.6
|
|
Psychosis Symptoms
PANSS Cognitive/Disorganized Factor Score at 8 wks
|
14.0 Symptom Scale Scores
Standard Error 0.7
|
12.8 Symptom Scale Scores
Standard Error 0.6
|
11.9 Symptom Scale Scores
Standard Error 0.6
|
13.7 Symptom Scale Scores
Standard Error 0.6
|
|
Psychosis Symptoms
PANSS Cognitive/Disorganized Factor Score at 12 wk
|
13.6 Symptom Scale Scores
Standard Error 0.7
|
12.7 Symptom Scale Scores
Standard Error 0.6
|
12.2 Symptom Scale Scores
Standard Error 0.6
|
13.0 Symptom Scale Scores
Standard Error 0.6
|
|
Psychosis Symptoms
PANSS Cognitive/Disorganized Factor Score at 16 wk
|
14.6 Symptom Scale Scores
Standard Error 0.7
|
12.5 Symptom Scale Scores
Standard Error 0.6
|
12.1 Symptom Scale Scores
Standard Error 0.6
|
12.4 Symptom Scale Scores
Standard Error 0.6
|
|
Psychosis Symptoms
NSA-16 Total Score at Baseline
|
44.5 Symptom Scale Scores
Standard Error 2.3
|
40.2 Symptom Scale Scores
Standard Error 2.2
|
42.5 Symptom Scale Scores
Standard Error 2.0
|
41.7 Symptom Scale Scores
Standard Error 2.2
|
|
Psychosis Symptoms
NSA-16 Total Score at 4 weeks
|
43.3 Symptom Scale Scores
Standard Error 2.3
|
40.2 Symptom Scale Scores
Standard Error 2.2
|
42.7 Symptom Scale Scores
Standard Error 2.0
|
41.1 Symptom Scale Scores
Standard Error 2.2
|
|
Psychosis Symptoms
NSA-16 Total Score at 8 weeks
|
44.4 Symptom Scale Scores
Standard Error 2.3
|
39.9 Symptom Scale Scores
Standard Error 2.2
|
41.5 Symptom Scale Scores
Standard Error 2.0
|
41.5 Symptom Scale Scores
Standard Error 2.2
|
|
Psychosis Symptoms
NSA-16 Total Score at 12 weeks
|
43.7 Symptom Scale Scores
Standard Error 2.3
|
40.6 Symptom Scale Scores
Standard Error 2.2
|
41.0 Symptom Scale Scores
Standard Error 2.0
|
42.1 Symptom Scale Scores
Standard Error 2.2
|
|
Psychosis Symptoms
NSA-16 Total Score at 16 weeks
|
46.5 Symptom Scale Scores
Standard Error 2.3
|
39.9 Symptom Scale Scores
Standard Error 2.2
|
41.5 Symptom Scale Scores
Standard Error 2.0
|
41.1 Symptom Scale Scores
Standard Error 2.2
|
SECONDARY outcome
Timeframe: Baseline, 8 weeks, and 16 weeksTo evaluate the efficacy of adjunctive valacyclovir, compared to placebo, to improve to improve global functional assessments as measured by the Clinical Global Impressions Severity Scale (CGI-S). The CGI-S is a single 7-point Likert scale rating severity of psychopathology on a scale of 1 (normal, not ill) to 7 (very severely ill).
Outcome measures
| Measure |
HSV1+ Valacyclovir
n=34 Participants
HSV1 positive subjects assigned to the Valacyclovir study treatment arm
|
HSV1+ Placebo
n=40 Participants
HSV1 positive subjects assigned to the HSV1+ placebo arm
|
HSV1- Valacyclovir
n=50 Participants
HSV1 negative subjects assigned to the Valacyclovir study treatment arm
|
HSV1- Placebo
n=46 Participants
HSV1 negative subjects assigned to the placebo arm
|
|---|---|---|---|---|
|
Functional Performance
CGI-S Scores at Baseline
|
3.6 scores on a scale
Standard Error 0.1
|
3.6 scores on a scale
Standard Error 0.1
|
3.5 scores on a scale
Standard Error 0.1
|
3.6 scores on a scale
Standard Error 0.1
|
|
Functional Performance
CGI-S Scores at 4 weeks
|
3.6 scores on a scale
Standard Error 0.1
|
3.5 scores on a scale
Standard Error 0.1
|
3.5 scores on a scale
Standard Error 0.1
|
3.5 scores on a scale
Standard Error 0.1
|
|
Functional Performance
CGI-S Scores at 8 weeks
|
3.5 scores on a scale
Standard Error 0.1
|
3.3 scores on a scale
Standard Error 0.1
|
3.4 scores on a scale
Standard Error 0.1
|
3.5 scores on a scale
Standard Error 0.1
|
|
Functional Performance
CGI-S Scores at 12 weeks
|
3.5 scores on a scale
Standard Error 0.1
|
3.5 scores on a scale
Standard Error 0.1
|
3.4 scores on a scale
Standard Error 0.1
|
3.5 scores on a scale
Standard Error 0.1
|
|
Functional Performance
CGI-S Scores at 16 weeks
|
3.5 scores on a scale
Standard Error 0.1
|
3.4 scores on a scale
Standard Error 0.1
|
3.3 scores on a scale
Standard Error 0.1
|
3.5 scores on a scale
Standard Error 0.1
|
Adverse Events
Valacyclovir
Placebo
Serious adverse events
| Measure |
Valacyclovir
n=84 participants at risk
3000mg daily oral 16 weeks
Valacyclovir HCI 500 mg tablets: Valacyclovir HCI 500 mg capsules 6/day oral for 16 weeks
|
Placebo
n=86 participants at risk
placebo 6 capsules daily oral 16 weeks
placebo: placebo capsules 6/day oral for 16 weeks
|
|---|---|---|
|
Psychiatric disorders
Psychotic Illness Exacerbation
|
3.6%
3/84 • Number of events 3 • Adverse event data were collected throughout the course of subject participation in the 16 week study.
|
4.7%
4/86 • Number of events 7 • Adverse event data were collected throughout the course of subject participation in the 16 week study.
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
1.2%
1/84 • Number of events 1 • Adverse event data were collected throughout the course of subject participation in the 16 week study.
|
0.00%
0/86 • Adverse event data were collected throughout the course of subject participation in the 16 week study.
|
Other adverse events
| Measure |
Valacyclovir
n=84 participants at risk
3000mg daily oral 16 weeks
Valacyclovir HCI 500 mg tablets: Valacyclovir HCI 500 mg capsules 6/day oral for 16 weeks
|
Placebo
n=86 participants at risk
placebo 6 capsules daily oral 16 weeks
placebo: placebo capsules 6/day oral for 16 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
6.0%
5/84 • Number of events 5 • Adverse event data were collected throughout the course of subject participation in the 16 week study.
|
0.00%
0/86 • Adverse event data were collected throughout the course of subject participation in the 16 week study.
|
Additional Information
Alan Breier, MD
Indiana University Psychotic Disorders Program
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place