Trial Outcomes & Findings for Systematic Evaluation of Antiviral Medication in Schizophrenia (NCT NCT00514449)
NCT ID: NCT00514449
Last Updated: 2018-06-14
Results Overview
This is a structured measure of severity of psychopathology that includes both positive and negative symptoms. The range is a minimum score of 30 and the maximum is 210. The lower scores suggest milder severity of illness domains.
COMPLETED
PHASE2
31 participants
Baseline, Weeks 2, 4, 6, 10, 14, 18
2018-06-14
Participant Flow
Subjects were recruited between 7/2007 and 8/2009 at two separate sites, Pittsburgh and Detroit. Recruitment took place through the local hospital and community mental health and school counseling centers, as well as other research studies and area mental health conferences.
Patients first had a placebo run-in for two weeks along with the psychiatric medications they were on and then randomized at Week 2 to either VAV or placebo group. Enrolled subjects were excluded due to cannabis abuse, claustrophobia, and a duration of illness that was too long.
Participant milestones
| Measure |
Valacyclovir
1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
|
Sugar Pill
2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
9
|
8
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Valacyclovir
1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
|
Sugar Pill
2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
2
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Systematic Evaluation of Antiviral Medication in Schizophrenia
Baseline characteristics by cohort
| Measure |
Valacyclovir
n=12 Participants
1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
|
Sugar Pill
n=12 Participants
2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
|
Total
n=24 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
|
12 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
29.6 years
STANDARD_DEVIATION 9.4 • n=93 Participants
|
28.7 years
STANDARD_DEVIATION 8.5 • n=4 Participants
|
29.2 years
STANDARD_DEVIATION 8.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
11 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
13 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=93 Participants
|
12 participants
n=4 Participants
|
24 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 10, 14, 18Population: Comparative analysis of active drug versus placebo
This is a structured measure of severity of psychopathology that includes both positive and negative symptoms. The range is a minimum score of 30 and the maximum is 210. The lower scores suggest milder severity of illness domains.
Outcome measures
| Measure |
Valacyclovir
n=12 Participants
1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks
|
Sugar Pill
n=12 Participants
2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
|
|---|---|---|
|
PANSS Positive and Negative Syndrome Scale for Schizophrenia
Scores at week 2 of the trial
|
72.25 Scores on the scale
Standard Deviation 11.450
|
77 Scores on the scale
Standard Deviation 14.917
|
|
PANSS Positive and Negative Syndrome Scale for Schizophrenia
Scores at Baseline of the trial
|
70.08 Scores on the scale
Standard Deviation 12.616
|
83.92 Scores on the scale
Standard Deviation 13.895
|
|
PANSS Positive and Negative Syndrome Scale for Schizophrenia
Scores at week 4 of the trial
|
67.36 Scores on the scale
Standard Deviation 12.314
|
75.2 Scores on the scale
Standard Deviation 13.998
|
|
PANSS Positive and Negative Syndrome Scale for Schizophrenia
Scores at week 6 of the trial
|
65.583 Scores on the scale
Standard Deviation 9.228
|
74.3 Scores on the scale
Standard Deviation 16.275
|
|
PANSS Positive and Negative Syndrome Scale for Schizophrenia
Scores at week 10 of the trial
|
65.2 Scores on the scale
Standard Deviation 10.737
|
73.2 Scores on the scale
Standard Deviation 12.044
|
|
PANSS Positive and Negative Syndrome Scale for Schizophrenia
Scores at week 14 of the trial
|
57.1 Scores on the scale
Standard Deviation 12.511
|
69.6 Scores on the scale
Standard Deviation 14.886
|
|
PANSS Positive and Negative Syndrome Scale for Schizophrenia
Scores at the end of the trial
|
56.5 Scores on the scale
Standard Deviation 9.289
|
67.125 Scores on the scale
Standard Deviation 13.726
|
PRIMARY outcome
Timeframe: Baseline, Week 18All results are given as the mean difference between an 18 week follow-up and the baseline battery administrations.This is a computerized test that measures both accuracy and response times. A range for response times is not available because of individual variabilities. Accuracy scores can vary for each test: Working memory accuracy range was 0-16. Verbal memory accuracy range was 0-20. For both, the higher the score the better. No cut offs are available
Outcome measures
| Measure |
Valacyclovir
n=12 Participants
1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks
|
Sugar Pill
n=12 Participants
2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
|
|---|---|---|
|
Cognitive Function Neuropsychological Battery (Gur Battery)
Immediate Verbal Memory Reaction Accuracy
|
2.44 units on a scale
Standard Deviation 2.62
|
-0.49 units on a scale
Standard Deviation 3.11
|
|
Cognitive Function Neuropsychological Battery (Gur Battery)
Working Memory: 2-Back Test Accuracy
|
2.13 units on a scale
Standard Deviation 2.68
|
0.13 units on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Baseline, Week 18Population: Analysis included on all participants on whom baseline and week 18 data were collected. Valacyclovir and placebo groups
Gray matter volume changes (in cc) were measured using structural MRI. Changes were reported as gray matter volume in cc. Note: Assessment of blood oxygenation level dependent (BOLD) changes using fMRI were erroneously included in the original study record.
Outcome measures
| Measure |
Valacyclovir
n=9 Participants
1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks
|
Sugar Pill
n=8 Participants
2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
|
|---|---|---|
|
Changes in Grey Matter Deficit
|
26.83 cm^3
Standard Deviation 5.04
|
24.22 cm^3
Standard Deviation 2.85
|
Adverse Events
Valacyclovir
Sugar Pill
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Valacyclovir
n=12 participants at risk
1 gram pill taken twice a day for 2 weeks, after 2 weeks it increased to 1.5 gram pill taken twice a day for 16 weeks.
|
Sugar Pill
n=12 participants at risk
2 placebo pills taken twice a day for 2 weeks, after 2 weeks 3 pills taken twice a day for 16 weeks.
|
|---|---|---|
|
Gastrointestinal disorders
Stomach Bloating
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
General disorders
Fatigue
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
Psychiatric disorders
Mild Extrapyramidal Symptoms
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in Elbow when Extended
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
Psychiatric disorders
Increased Sexual Drive
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Leg Cramps
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
Gastrointestinal disorders
Constipation
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
Gastrointestinal disorders
Stomach Pain
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
Nervous system disorders
Motion Sickness
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
Nervous system disorders
Tongue Twitch
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
|
Nervous system disorders
Slight Tremor
|
8.3%
1/12 • Number of events 1 • 2, 4, 6, 10, 14, and 18 weeks.
|
0.00%
0/12 • 2, 4, 6, 10, 14, and 18 weeks.
|
Additional Information
Dr. Konasale Prasad
Western Psychiatric Institute and Clinic
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place